Q1 2024 LENZ Therapeutics Inc Earnings Call

Operator: Ladies and gentlemen, thank you for standing by. At this time, I would like to welcome everyone to Lenz Therapeutics' first quarter 2024 financial results and business update. All lines have been placed on mute to prevent any background noise.

Ladies and gentlemen, thank you for standing by at this time I would like to welcome everyone to that instead of a few things first quarter 'twenty 'twenty four financial results and business update.

Operator: All lines have been placed on mute to prevent any background noise.

Operator: 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 the 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 Chevallard. Please go ahead, sir.

Operator: After the Speakers' remarks, there will be a question and answer session.

Dan Chevallard: If you would like to ask a question. During this time simply press star followed by the number one on your telephone keypad.

Dan Chevallard: If you would like to withdraw your question again with the Starwood. Thank.

Dan Chevallard: I would now like to turn the conference over to Dan Chevrolet. Please go ahead Sir.

Dan Chevallard: Thank you. Good afternoon everyone, and thank you for joining us today to discuss Lenz's first quarter 2024 financial results and business update. My name is Dan Chevillard, Chief Financial Officer of Lenz Therapeutics. We are joined today by Abe Shimmelpenick, our President and Chief Executive Officer, who will provide our business update, as well as Dr. Mark Odrich, Chief Medical Officer, and Shawn Olson, Chief Commercial Officer, both of whom will join us for Q&A.

Dan Chevallard: Thank you good afternoon, everyone and thank you for joining us today to discuss lenses, the first quarter 2024 financial results and business updates.

Dan Chevallard: My name is Dan shovel, our Chief financial Officer of lens Therapeutics.

Dan Chevallard: We are joined today by <unk> <unk>, our president and Chief Executive Officer, who will provide our business update as well as Dr. Mark <unk>, Chief Medical Officer, and Sean Olson, Chief Commercial officer, both of whom will join us for Q&A.

Dan Chevallard: 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, cash runway projections, and performance, which constitute forward-looking statements. However, 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 obligation to update such statements.

Dan Chevallard: Before we begin I would like to remind you that this call will contain forward looking statements regarding linzess future expectations plans prospects corporate strategy cash runway projections and performance, which constitute forward looking statements.

Dan Chevallard: 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 SEC.

Dan Chevallard: 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.

Abe Shimmelpenick: With that, I will now turn the call over to Dan. 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 Lenz. In March, we completed our merger with Graphite.

Dan Chevallard: With that I will now turn the call over to H.

Abe Shimmelpenick: Thank you Dan and thank you everyone for joining us today.

Dan Chevallard: Let me start by saying that the first quarter of 'twenty 'twenty four and the weeks following have been transformative for loans.

Abe Shimmelpenick: Bio and a concurrent $53.5 million pipe finance. As a result, we became a public company trading on NASDAQ under the ticker Lenz. 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.

Dan Chevallard: In March we completed our merger with gratify bio and a concurrent $53 $5 million pipe financing.

Abe Shimmelpenick: And as a result, we became a public company trading on NASDAQ under the ticker <unk>.

Abe Shimmelpenick: These transactions allowed us to be well capitalized with around $213 million of cash and cash equivalents at the end of the quarter on our balance sheet.

Abe Shimmelpenick: 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 Lenz and Graphite, as well as advisors on both sides that got us into 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 recycling product, as our commercial candidate to treat presbyopia.

Abe Shimmelpenick: Importantly, we anticipate this cash balance to be sufficient to fund our operations to post launch positive operating cash flow.

Abe Shimmelpenick: I want to acknowledge the hot work that went into this and thank the teams at both labs and graphite.

Abe Shimmelpenick: As well as advisors on both sides that got us to a strong position.

Abe Shimmelpenick: Only a few weeks after our public debut we announced a positive clarity phase III data and selected LNG, one hundreds a single agent our cycling products as our commercials candidates to treat presbyopia.

Abe Shimmelpenick: 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.

Abe Shimmelpenick: 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.

Abe Shimmelpenick: As the crystalline lens is hottest with H now is less able to accommodate and focus the incoming light for near vision on the retina, resulting in blurry near vision.

Abe Shimmelpenick: 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.

Abe Shimmelpenick: Although the progression of presbyopia is gradual presbyopia, often experienced an abrupt change in the daily life as the symptoms become more pronounced starting in that mid forty's.

Abe Shimmelpenick: When reading glasses or auto corrective eights are suddenly necessary to read text will conduct close off book.

Abe Shimmelpenick: To address the daily challenges faced by Presbyopia, we are developing a once daily <unk>.

Abe Shimmelpenick: Pharmacological Eyedrop that has been shown to be capable of improving near vision throughout the full workday without the need for reading losses.

Abe Shimmelpenick: Before I give a brief summary of the positive clarity top-line data, I want to highlight that throughout the development of LMZ100, 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 higher 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.

Abe Shimmelpenick: Before I give a brief summary of the positive clarity topline data I want to highlight that throughout the development of LNG 100 <unk>.

Abe Shimmelpenick: Our objective has always been to commercialize the product that we believe will most effectively meet the needs of the widest range of presbyopia.

Abe Shimmelpenick: And best create loyalty and value based on all eyes, All day brand mission.

Abe Shimmelpenick: That means that we're not only aiming for higher 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.

Abe Shimmelpenick: 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 age 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.

Abe Shimmelpenick: This is why we made sure that the close to 1100 participants and a clarity studies represented the majority up to 128 million passenger hopes in the U S alone.

Abe Shimmelpenick: We included participants.

Abe Shimmelpenick: 45% to 75 with a mean age of 55.

Abe Shimmelpenick: We also made sure to include people that had a wide range of effective Arris think of this as including people that need to wear contact lenses or glasses to correct that distance vision, but also people that have never had to wear and distance vision correction and alive.

Abe Shimmelpenick: We make sure to also include people that have 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 presbyopia. 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 pest bureaus globally.

Abe Shimmelpenick: We made sure to also include people that had previously undergone lasik and cataract surgery.

Abe Shimmelpenick: And importantly, we included participants with a wide range of presbyopia to make sure that we have a product that can be.

Abe Shimmelpenick: Two mild moderate and severe Ah <unk>.

Abe Shimmelpenick: By doing so we feel confident that the results of regenerate it truly reflect the potential benefits for the LNG 100 can bring to the vast majority of the close to 2 billion passenger hopes globally.

Abe Shimmelpenick: On that note, let's talk about the key outcomes of the Clarity Phase 3 study in which LMZ100, 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, we are focusing on the results of the Clarity 2 trial, as this is the direct vehicle control trial. LNZ100 showed a rapid onset with 71% 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 3 hours, we also observed a 3-line or more responder rate of 71%.

Abe Shimmelpenick: On that note, let's talk about the key outcomes of the clarity phase III study in which LNG 100, a single agent or cycling product candidates continue to show strong performance and best in class potential.

Abe Shimmelpenick: Consistent with previous trials for a moment focusing on the results for the clarity to trial and this is this is the direct vehicle controlled trial.

Abe Shimmelpenick: 100, <unk> showed a rapid onset with 71% of participants achieving three lines or more of near vision improvement without losing one lino more distance vision at 30 minutes on the very first day of use of the products.

Abe Shimmelpenick: At the primary endpoint of three outlets. We also observed a three line of more respond the rates of 71%.

Abe Shimmelpenick: 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 trial. All results were highly statistically significant, with p-values at each time point of less than 0.0001. We also saw a very impressive near-universal response to LNG-100, 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 patients.

Abe Shimmelpenick: LNG 100 also maintained high levels of near vision improvement with 40% of participants achieving three lines or more of near vision improvement at 10 Atlas. The last time point measured in our efficacy trials.

Abe Shimmelpenick: All results were highly statistically significant with P values at each time point of less than <unk> Triple zero.

Abe Shimmelpenick: We also saw a very impressive near Universal response to LNG one hundreds.

Abe Shimmelpenick: With 95% of participants achieving at least two lines of near vision improvements.

Abe Shimmelpenick: This is an important measure because it was seen as clinically meaningful and significant for most possibly hopes.

Abe Shimmelpenick: Notably, 69% of the participants still reported this improvement at the end of the day, 10 hours after dosing. In both efficacy trials, Clarity 1 and 2, the participants used their assigned treatment agent every day for 42 days.

Abe Shimmelpenick: Notably 69% of the participants still reported there is improvement at the end of the day 10 hours after dosing.

Abe Shimmelpenick: And both the efficacy trials clarity wanted to the participants to use their assigned treatment agents every day for 42 days.

Abe Shimmelpenick: We saw similarly high response rates for LNZ100 across both trials on the various days we brought participants in for measurement. In terms of safety, LNZ100 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.

Abe Shimmelpenick: We saw a similarly high response rates for LNG, one hundreds across both trials at the various days, we brought participants and for measurements.

Abe Shimmelpenick: And so as a safety LNG 100, plus seem to be well tolerated with no treatment related serious adverse.

Abe Shimmelpenick: Adverse events observed and the over 30000 treatment days across all III clarity trials.

Abe Shimmelpenick: Although reported non serious adverse events, 95% were classified as mild believed to be transient and consistent with those observed in previous trials.

Abe Shimmelpenick: Commercial potential was further confirmed by participant surveys, with 90 percent of participants noticing an improvement in near vision, and 75 percent of them indicating that they would continue to use LMZ100 after the study. Together with the broad inclusion criteria we mentioned earlier, we believe this positions M&Z 100 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 insight.

Abe Shimmelpenick: Commercial potential was further confirmed by participants surveys with 90% of participants noticing on improvement in near vision and 75% of them, indicating that they would continue to use LNG 100. After the study.

Abe Shimmelpenick: To get at what the broad inclusion criteria. We've mentioned earlier, we believe dispositions LNG 100, well for the estimated over $3 billion potential market opportunity.

Abe Shimmelpenick: We recently received the full datasets up to three clarity trials currently analyzing them for additional insights.

Abe Shimmelpenick: 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 the nearly universal high efficacy of LNG100. For example, looking at pooled data across both of our efficacy trials, clarity one and two, we see that not only did 97% of participants achieve at least a three-line improvement at some point, but an impressive 84% improved their near vision by at least four or more lines.

Abe Shimmelpenick: 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 LNG 100.

Abe Shimmelpenick: For example, looking at both data across both of our efficacy trials carrier wanted to we see that not only did 97% of participants achieve at least a three line improvement at some point.

Abe Shimmelpenick: But in an impressive 84% improve that near vision by at least four or more lines.

Abe Shimmelpenick: 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 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 3 results beyond the already shared topline results. We're excited to announce that we're planning a Phase 3 Capstone KOL event on June 18. 2024 in New York City.

Abe Shimmelpenick: We believe that these results indicate that the vast majority of people that if approved sample the product.

Abe Shimmelpenick: Notice of rapid and meaningful improvement in the near vision.

Abe Shimmelpenick: 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.

Abe Shimmelpenick: As mentioned, we are conducting analysis of the full dataset for phase III results BMP already share top line results.

Abe Shimmelpenick: We're excited to announce that we are planning a phase III capstone Kols event on June 18th.

Abe Shimmelpenick: 2024 in New York City.

Abe Shimmelpenick: 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 clinical practice and the 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, I'm pleased to share that the Clarity Phase III study was designed in close alignment with the FDA, and the positive top-line data generated concludes the clinical development program for LNZ100.

Abe Shimmelpenick: 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.

Abe Shimmelpenick: For our clinical practice in markets and firsthand experiences with LNG one hundreds.

Abe Shimmelpenick: We look forward to providing additional information on these events in the weeks ahead.

Abe Shimmelpenick: Okay.

Abe Shimmelpenick: Turning to our upcoming NDA submission I am pleased to share that the clarity phase III study was designed in close alignment with the FDA and the positive topline data generated concludes the clinical development program for LNG one hundreds.

Abe Shimmelpenick: The team is now fully focused on the execution of the filing, and we are well on track to submit our NDA for LNG-100 to the FDA in mid-2014. In parallel to working towards our NDA submission, our commercial launch preparations are also well underway. In February 2024, Lenz launched its unbranded IAM campaign to educate and excite eye care professionals about future presbyopia solutions. Over 40 key opinion leaders are involved in the campaign and are featured at iamselected.com, where eye care professionals can learn about ideal pupil size, iris muscle selectivity, and expected early adopters of presbyopia eye drops.

Abe Shimmelpenick: The team is now fully focused on the execution of the filing.

Abe Shimmelpenick: Well on track to submit our NDA for LNG, one hundreds to the FDA in mid 2014.

Abe Shimmelpenick: In parallel to working towards our NDA submission our commercial launch for Fatness is also well underway.

Abe Shimmelpenick: In February 2024.

Abe Shimmelpenick: <unk> launched its unbranded I am campaign.

Abe Shimmelpenick: Campaign to educate and X sight eyecare professionals about future presbyopia solution.

Abe Shimmelpenick: Over 40 key opinion leaders are involved in the campaign and are featured at <unk>.

Abe Shimmelpenick: Selected.

Abe Shimmelpenick: That is D E.

Abe Shimmelpenick: Selected dot com.

Abe Shimmelpenick: But I kept professionals kind of learn about ideal pupil size arris muscle cell activity.

Abe Shimmelpenick: Early adopters of Presbyopia eyedrops.

Dan Chevallard: To continue that momentum and to support the projected launch following potential FDA approval, Lenz is actively building out its U.S. commercial capability, 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 Lenz. With that, I'll hand it over to Dan, our CFO, for an update on our financial results. Thank you, Aif.

Abe Shimmelpenick: Continuing on that momentum and to support the projected launch following potential FDA approval lenses actively building out its U S commercial capabilities.

Dan Chevallard: Highlighted by completion of third party logistics contracting in the first quarter of 224, and the addition of key commercial expertise and direct to consumer and influenza marketing.

Dan Chevallard: All in preparation for a potential launch of LNG 100.

Dan Chevallard: Early in the second half of try and 75.

Dan Chevallard: In summary, we are very pleased with the progress the team has made on all fronts.

Dan Chevallard: The recent period has been and promises to continue to be a very exciting time Atlanta.

Dan Chevallard: With that I'll hand, it over to Dan.

Dan Chevallard: CFO for an update on our financial results.

Dan Chevallard: As Aif mentioned, we're pleased with the successful close of the merger transaction and concurrent pipe, having ended Q1 with approximately $213.3 million in cash, cash equivalents, and marketable security, inclusive of the over $117 million acquired in the recent merger and the $53.5 million in proceeds from the concurrent private placement. Importantly, we announced today that this is anticipated to fund the company's cash runway through to post-launch positive cash flow from operations. We believe this puts us in a strong position to focus on execution.

Dan Chevallard: Thank you as <unk>.

Dan Chevallard: <unk> mentioned, we are pleased with the successful close of the merger transaction and concurrent pipe having ended Q1 with approximately $213 3 million in cash cash equivalents and marketable securities inclusive of the over $117 million acquired in the recent merger and to $53 5 million.

Dan Chevallard: And proceeds from the concurrent private placement.

Dan Chevallard: Importantly, we announced today that this is anticipated to fund the company's cash runway through to post launch positive cash flow from operations.

Dan Chevallard: We believe this puts us in a strong position to focus on execution.

Dan Chevallard: Our operating results and resulting cash burn for the first quarter were substantially in line with our plan. As is common around transactions such as what we just completed, there have been, and will be into the second quarter, certain non-recurring or one-time transaction costs. Those aside, our total operating expenses, inclusive of both research and development and sales general and administrative expenses, for Q1 2024 were approximately $16.1 million, compared to $12.6 million for the same period in 2023.

Dan Chevallard: Our operating results and resulting cash burn for the first quarter were substantially in line with our plan.

Dan Chevallard: As is common around transactions such as what we just completed there have been and will be into the second quarter, certain nonrecurring or onetime transaction costs.

Dan Chevallard: As a side our total operating expenses inclusive of both research and development and sales general and administrative expenses for Q1 2024 were approximately $16 1 million compared to $12 6 million for the same period in 2023.

Dan Chevallard: Overall, this increase was substantially a result of additional operating costs incurred in our preparations for being a publicly traded company and early commercial planning. More specifically, our research and development expenses for Q1 2024 were $10.5 million, which was materially consistent with research and development expenses of $10.3 million for the same period in 2023. Substantially, all research and development expenses incurred for these comparative periods related to the clinical development and manufacturing required to support our Phase 2 Insight and Phase 3 Clarity clinical trials. Selling general and administrative expenses for Q1 2024 increased to $5.6 million, compared to $2.3 million for the same period in 2023.

Dan Chevallard: Overall this increase was substantially a result of additional operating costs incurred in our preparations for being a publicly traded company and early commercial planning.

Dan Chevallard: More specifically our research and development expenses for Q1, 2024 were $10 5 billion.

Dan Chevallard: Which was materially consistent with research and development expenses of $10 3 million for the same period in 2023.

Dan Chevallard: Substantially all research and development expenses incurred for these comparative periods related to the clinical development and manufacturing required to support our phase II insight and phase III clarity clinical trials.

Dan Chevallard: Selling general and administrative expenses for Q1, 'twenty 'twenty four increased to $5 6 million compared to $2 3 million for the same period in 2023.

Dan Chevallard: This increase was primarily driven by costs associated with preparations to be a publicly traded company, in addition to an increase in prelaunch commercial activities. As well, expenses in Q1 2024 included a non-recurring, non-cash, stock-based compensation charge associated with the merger. Finally, our net loss per share, both basic and diluted, was $3.53 per share in the first quarter of 2024 on a net loss of $16.6 million, compared to a net loss per share of $6.50 per share in the first quarter of 2023 on a net loss of $12.7 million.

Dan Chevallard: This increase was primarily driven by costs associated with preparations to be a publicly traded company. In addition to an increase in prelaunch commercial expenses.

Dan Chevallard: Please note that these loss per share figures consider only the weighted average common stock outstanding for the respective period and thus, most notably for Q1 2024, do not fully weight any of, one, the convertible preferred and convertible common stock from pre-merger private Lenz that converted into common stock upon the merger close, totaling 11.3 million shares. Two, the shares acquired from legacy Graphite shareholders as of the merger date, totaling 8.3 million shares

Dan Chevallard: <unk> expenses in Q1 2024 included a nonrecurring noncash stock based compensation charge associated with the merger.

Dan Chevallard: Finally, our net loss per share both basic and diluted was $3 53 per share in the first quarter 2020 for on a net loss of $16 6 million.

Dan Chevallard: Compared to a net loss per share of $6 50 per share in the first quarter of 2023 on a net loss of $12 7 million.

Dan Chevallard: Please note that these loss per share figures considered only the weighted average common stock outstanding for the respective periods.

Dan Chevallard: Thus, most notably for Q1 2024 do not fully weight any of one the convertible preferred convertible common stock from pre merger private lens that converted into common stock upon the merger close totaling 11 3 million shares.

Dan Chevallard: To the shares acquired from legacy graphite shareholders as of the merger date totaling $8 3 million shares or three shares of common stock issued in the 2024 concurrent private placement totaling $3 6 million shares.

Dan Chevallard: Or three, shares of Common Stock issued in the 2024 concurrent private placement totaling 3.6 million. More simply stated, we ended Q1 2024 with approximately 25.5 million shares of common stock outstanding, most of which were not fully weighted in our Q1 2024 net loss per share previously known. Now, as we advance from here, our allocation of capital will begin to change over the balance of the year, and we would like to take a moment to highlight the following three key items at this point.

Dan Chevallard: More simply stated we ended Q1 2024 with approximately $25 5 million shares of common stock outstanding most of which were not fully weighted.

Dan Chevallard: In our Q1 2024 net loss per share previously noted.

Dan Chevallard: First, research and development and clinical development spend will decrease over 2024 due to the winding down of our positive phase 3 clarity study while prioritizing the financial support necessary to enable a successful mid-2024 NDA submission. Second, we plan to allocate more emphasis and more capital toward the ramp-up of our commercial infrastructure and pre-launch activities over the balance of the year. And third, despite the non-recurring nature of our transaction-related costs, we will aim to maintain discipline in managing our general and administrative costs associated with being a newly publicly traded company.

Dan Chevallard: Now as we advance from here our allocation of capital will begin to change over the balance of the year and we would like to take a moment to highlight the following three key items on this point.

Dan Chevallard: First research and development and clinical development spend will decrease over 2024 due to the wind down of our positive phase III clarity studies.

Dan Chevallard: Prioritizing the financial support necessary to enable a successful mid 2020 for NDA submission.

Dan Chevallard: Second we plan to allocate more emphasis and more capital towards the ramp up of our commercial infrastructure and prelaunch activities over the balance of the year.

Dan Chevallard: And third eliminating for the nonrecurring nature of our transaction related costs, we will aim to maintain discipline in managing our general and administrative costs associated with being a newly publicly traded company.

Dan Chevallard: We look forward to executing on what is a clear path forward for the company towards NDA submission in mid-2024 and the potential approval and commercial launch of LMZ 100 in the second half of 2020. With that, I'll turn the call back over to you. Thanks, Dan. Operator, we're now happy to take questions. Thank you. The floor is now open for questions. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue.

Dan Chevallard: We look forward to executing on what is a clear path forward for the company towards NDA submission in mid 2024, and the potential approval and commercial launch of LNG 100 in the second half of 2025.

Dan Chevallard: With that I'll turn the call back over to H.

Dan Chevallard: Thanks, Dan.

Dan Chevallard: Operator, we're now happy to take questions.

Speaker Change: Thank you.

Dan Chevallard: Thanks for the questions. If you have dialed in we would like to ask a question. Please press star one on your telephone keypad duration and Janney Keith if.

Dan Chevallard: If you would like to withdraw your question simply press Star one again.

Dan Chevallard: If you would like to withdraw your question, simply press star 1 again. Your first question comes from the line of Joseph Cantazzaro with Piper Sandler. Your line is open. Hey everybody, I appreciate you taking my questions. Maybe two quick ones for me.

Dan Chevallard: Your first question comes from the line of Joseph <unk> with Piper Sandler Your line is open.

Joseph Cantazzaro: Hi, everybody I appreciate you taking my questions, maybe two quick ones for me.

Operator: First, on the NDA submission, can you maybe just help us better understand some of the gating factors there to getting that filing done? Is it mostly paperwork, or are there sort of other things going on in the background, and is there any risk to maybe the timeline slipping there as you wait for some of those things to get done? And then second, maybe as we look towards the KOL event, are there any sort of additional analyses that you're performing within the clarity data sets and sort of maybe some new things we might expect to see at that June event and what could be important there? Thanks. Thank you all. Great questions. Let me take them.

Joseph Cantazzaro: First on the NDA submission can you maybe just help us better understand some of the gating factors there to getting that filing done is it mostly paperwork or are there sort of other things going on in the background and is there any risk to maybe timeline slipping. There you wait for some of those things to get done and then second.

Speaker Change: As we look towards the Kols event.

Speaker Change: Are there any sort of additional analyses that you are performing within the clarity datasets and sort of maybe some new things we might expect to see.

Speaker Change: At June.

Operator: <unk> event and what could be important there. Thanks.

Abe Shimmelpenick: So first one, as we work towards the NDA submission in the middle of the year. So, like I said, we believe that with the CLARITY trials, we've now completed our full clinical program, and we have the final pieces of the clinical data in our hands. Over the years, we've been very well aligned, and we will continue to be very well aligned with the FDA. So we have high confidence in the fact that we have a complete data set.

Speaker Change: Thanks, Joe Great questions.

Abe Shimmelpenick: Take them. So first one as we work towards the NDA submission.

Abe Shimmelpenick: In the middle of the year.

Abe Shimmelpenick: So like I said, we believe that with the clarity trials, we've completed now.

Abe Shimmelpenick: Full clinical program and we have the final pieces of the clinical data in our hands.

Abe Shimmelpenick: Over the years, we've been very well aligned and will continue to be very well aligned with the FDA. So we have high confidence in the fact that we have a complete data sets and.

Abe Shimmelpenick: And therefore, the team is now really fully focused on compiling the NDA. So, you know, to paraphrase what you were saying, it is paperwork from here on out. Doesn't mean that it's not a lot of work, and therefore the team is really focused on that. You know, we have the right people in place.

Abe Shimmelpenick: And therefore the team is now really fully focused on compiling the NDA so to paraphrase what you were saying.

Abe Shimmelpenick: It is stable from here on out.

Abe Shimmelpenick: It doesn't mean that there's not a lot of work and therefore the team is really focused on that.

Abe Shimmelpenick: We have the right people in place. So we're very confident that we will meet that submission timeline that we've guided to.

Abe Shimmelpenick: So we're very confident that we will meet that submission timeline that we've guided to the middle, in the middle of 2024. So, your second question as to the KOL event, again, as we've mentioned on the call, we now have the full data sets of all our three studies, and teams on both sides are analyzing them for additional insight. What we're looking for and what we're starting to see is, you know, really interesting and exciting data around efficacy, how does this product work for the different groups that are in the study, as it works for mild, moderate, severe presbyopia, any difference in response based on age, how the LASIK patients respond.

Abe Shimmelpenick: In the middle of 2024.

Abe Shimmelpenick: So, those are some of the things that we're excited to share at the upcoming KOL event. And secondly, it's a great opportunity for, you know, people outside of Lenz to actually share their views on the data, how they see this working in the market, and as I've mentioned, we'll also have lead investigators from the CLARITY trial that have, you know, true first-hand experience with our product and potentially also with other products that will share their views on, you know, how it performs in that patient. Okay. Great That's all super helpful. I appreciate you taking the time to answer my questions. Thanks. Thanks, Joe. The next question comes from the line of Egal Nokomovits with Citigroup. Your line is open.

Abe Shimmelpenick: So second question is.

Egal Nokomovits: At a KOL event.

Operator: Hi Ace and team, thank you so much. Ace, you mentioned some of the pool data that you're looking at with the full data set. Is any of that potentially something that could make its way into the label language? Or is that more going to stay with the, you know, on the marketing claim front? No, great question, Yigal.

Egal Nokomovits: Again, as we've mentioned on the call. We now have the full datasets over the last three studies teams on both sides.

Speaker Change: <unk> them for additional insight.

Abe Shimmelpenick: Thanks for joining the call. So looking at the label, the label we actually expect to be fairly broad to begin with. So if you look at the beauty label, it basically states for the treatment of presbyopia. So it's hard to expand that label.

Speaker Change: But we're looking for and what we're starting to see is really interesting and exciting data.

Abe Shimmelpenick: Around efficacy.

Abe Shimmelpenick: How does this work for the different groups that are in the study doesn't.

Yigal: Does it work for mild moderate severe presbyopia.

Yigal: Any difference in responds on H lasik patients respond. So those are some of the things that we're excited to share at the upcoming <unk> events and secondly, it's a great opportunity for people outside of lens to actually share that view on the data hub.

Abe Shimmelpenick: Now, on the label itself, you'll actually have data cutouts. And that's where the marketing team will continue to advertise and will be able to point at that. So we feel this is very important data to ultimately commercialize our product, but also for our health care professionals to look at and continue to gain confidence in how the product performs. So again, we are very excited to see some early data cuts from that data. And as we continue to validate that, we'll start sharing it at our KOL event in June.

Abe Shimmelpenick: Thanks. And then, with regard to the filing of the NDA, I believe you were also on track to complete some of the stability studies for the product. Given that you're not taking Lenz 101 forward but rather Lenz 101, is that any faster to finish that stability? Or are both of those basically on the same timetable? Yeah, no, both were and are on the same timetable, as hard as I sometimes try to move times faster, but that's impossible, obviously.

Abe Shimmelpenick: I see this work in the market and as I've mentioned also have also have lead investigators from the clarity trial that have true firsthand experience with our product and potentially also what other products that will share their views.

Abe Shimmelpenick: However, our performance in that patients.

Speaker Change: Okay, Great. That's all Super helpful. I appreciate you taking my questions.

Speaker Change: Thanks, Joe.

Abe Shimmelpenick: Next question comes from the line of Vega <unk> with Citigroup. Your line is open.

Speaker Change: Hi team. Thank you so much.

Speaker Change: Thank you mentioned some of the pool data that youre looking at with the full dataset.

Abe Shimmelpenick: Is there any of that potentially something that could make its way into into the label language or is that more going to stay with the on the marketing claims.

Speaker Change: No great question Yigal. Thanks for thanks for joining the call. So looking at the label the label that we actually expect to be fairly broad to begin with so if you look at the view to label. It basically states for the treatment of presbyopia. So yes, it's hard to expand that label now.

Abe Shimmelpenick: In the label itself actually have data caught up so that's where the marketing team will continue and we'll be able to point at that so we feel that it is very important data to ultimately commercialize our products, but also for our health care professionals to look at and continue to.

Abe Shimmelpenick: Gain confidence and auto product performs.

Abe Shimmelpenick: Im very excited to see some early data cups of that data and as we continue to validate that.

Abe Shimmelpenick: We'll start sharing that.

Abe Shimmelpenick: Okay.

Abe Shimmelpenick: Event in June.

Speaker Change: Thanks, and then with regard to the filing of the NDA I believe you were also.

Abe Shimmelpenick: On track for completing some of the stability studies for the product.

Abe Shimmelpenick: Given that youre, not thinking lens 101 forward, but rather 101.

Abe Shimmelpenick: Is that any faster to finish that stability.

Abe Shimmelpenick: Both of those basically on the same the same timetable.

Abe Shimmelpenick: Yes, both.

Abe Shimmelpenick: And on the same timetable.

Abe Shimmelpenick: How does that sometimes tried to move times.

Abe Shimmelpenick: Mr.

Abe Shimmelpenick: So what truly is bound by the stability clock, and that is going into filing timing. And then just the last one on distance vision, you had some interesting data suggesting a potential benefit on distance. How much of that is going to be emphasized in your marketing pitch, or is that not going to really be the focus? I think, again, that that's going to be a great additional benefit.

Abe Shimmelpenick: That's impossible, obviously, so what truly bound body severity clock and that is going into a filing.

Abe Shimmelpenick: <unk>.

Abe Shimmelpenick: And then just the last one on the distance vision.

Abe Shimmelpenick: <unk> had some interesting data, suggesting a potential benefit on distance.

Abe Shimmelpenick: How much of that is going to be emphasized in your marketing pitch.

Abe Shimmelpenick: That's not going to really be the focus.

Abe Shimmelpenick: I think again that thats going to be.

Abe Shimmelpenick: Additional benefit so while it.

Abe Shimmelpenick: So while it's likely not going to be a label claim, that's not what we're striving for, it is data that we will aim to have included in the label, and therefore, the marketing team can highlight that. We do feel it's a very substantial benefit. One of the additional data cuts that we're looking at is, is there a certain population that notices this more than others or feels the benefit more? And one of the things that, again, anecdotally, we hear is that especially people that have previously had LASIK and know what 20-20 distance vision looks like, over time, they have lost a little bit, you know, back to 20-25 or 20-30, appear to feel that So while it's not a label claim, we feel it's definitely a benefit that is, you know, additive to the near vision effect. Okay, great. Thank you very much.

Abe Shimmelpenick: It's likely not going to be a label claim is not always driving for it is data that we will aim to have included in the label and therefore, the marketing team Ken can highlight that.

Abe Shimmelpenick: We do feel it's a very substantial benefit.

Abe Shimmelpenick: The.

Abe Shimmelpenick: Additional data costs that we're looking at is if there is.

Abe Shimmelpenick: A certain population that notice of this more than audits or feel the benefit more in one of the things that again anecdotally. We hear is that especially people that have previously had lasik.

Abe Shimmelpenick: And know what 2020 distance vision looks like over time may have lost a little bit back to 20, 25% to 2030.

Abe Shimmelpenick: Appear to feel that benefit so while it's not a label claim we feel it's definitely a benefit that is additive to the near vision effect. That's obviously the main driver of the upper level.

Abe Shimmelpenick: Okay, great. Thank you very much.

Speaker Change: Thanks for your question.

Abe Shimmelpenick: From the line of Tim Lugo with William Blair. Your line is open.

Operator: Thank you all. Thank you for the question and congratulations on all the progress in the quarter. I know it's a very pivotal quarter for the company. My question is, can you talk about the transient nature of the adverse events that were observed in Clarity? I know I've heard some questions around the headache rates, but also, you know, when I look at it, maybe you can talk about that.

Speaker Change: Thank you for the question and congratulations on all the progress in the quarter.

Operator: Alright pivotal quarter for the company.

Operator: My question is can you talk about the transient nature of the adverse events were observed and clarity.

Operator: I have heard some questions around the headache right.

Operator: But also.

Operator: When I look at it maybe you can talk.

Abe Shimmelpenick: Anything you're hearing from the market, because we're not seeing some other successful eye care products like dry eye and then also maybe other presbyopia products. The adverse event rate, you need to compare well for clarity. So can you maybe speak to that a bit?

Operator: Any anything you're hearing from the market because of what I've seen in some other.

Abe Shimmelpenick: First of all I care products like dry.

Abe Shimmelpenick: And then also maybe the other.

Abe Shimmelpenick: DLP products, the adverse event rate compare well for clarity.

Abe Shimmelpenick: Can you maybe speak to that a bit.

Abe Shimmelpenick: Absolutely. Thanks, Tim, for that question. I think first and foremost, and then I'll get to the other adverse events, you know, the big thing that we're very pleased with to see in our AE data is that across 30,000 patient treatment days, there were zero serious adverse events. So I think that, first and foremost, speaks to what we believe the safety of the product and the profile of the product is, and it's obviously different than some of the other products that we've seen out there And that's really true because of the difference in the mechanism of action of the cyclin and how it does not stimulate the ciliary body.

Speaker Change: Absolutely. Thanks, Thanks, Tim for that question so.

Abe Shimmelpenick: I think first and foremost and I'll get to the other.

Abe Shimmelpenick: Diverse events.

Abe Shimmelpenick: The Big thing that we're very pleased with to C&I data is that across 30000 patient treatment days, there was zero serious adverse events. So I think thats first and foremost speaks to what we believe the safety of the product and the profile of the product is.

Abe Shimmelpenick: Obviously different than some of the other products that we've seen out there that's really truly.

Abe Shimmelpenick: Because of the difference of the mechanism of action of Osaka that on how it does not stimulate subsidiary body.

Abe Shimmelpenick: So if you now look at the non-serious... treatment-related AEs, headaches, and some of the other ones that we've noticed. Again, importantly, there, 100% or close to 100% are classified as mild. So, in general, we see and the feedback that we get from patients is that this is a very highly tolerable product, very comfortable, with very minor AE issues. To your point, if you compare that to some of the other very successful products, our AST profile is the same, or you could argue better than those products. You're asked whether they are transients or permanent residents.

Abe Shimmelpenick: So if you then look at the non serious treatment related aes headaches and some of the other ones that we've noticed again importantly, there are 100% or close to a 100% are classified as miles. So in general we see in the.

Abe Shimmelpenick: The feedback that we got from patients.

Abe Shimmelpenick: This is a very highly tolerable product comfortable with very minor.

Abe Shimmelpenick: Issues.

Abe Shimmelpenick: To your point, if you compare that to some of the other very successful products.

Abe Shimmelpenick: <unk> profile as to say well you could argue better.

Abe Shimmelpenick: And then those products.

Abe Shimmelpenick: You asked whether they were transient.

Abe Shimmelpenick: So everything that we're seeing suggests that they are. So we obviously have done our phase 2 trials. I have a lot of data there, and we're going through the data on our phase 3 trials now. So, if you look at what's called insulation site irritation, that's basically, if you put an eye drop in your eye, some people feel a mild, very brief sting.

Abe Shimmelpenick: We think that we're seeing suggests that they are so we obviously have done a phase II trials have a lot of data that I will go through the data on our phase III trials now.

Abe Shimmelpenick: Yeah, think of that as a blink or two, and that's gone. So, that's definitely transient. The other ones, as well, they all go away very, very quickly.

Abe Shimmelpenick: If you look at the let's call an installation site irritation. That's basically if you put it and I dropping your some people feel a mild very brief thing think of that as a blinker too and Thats gone. So that's definitely transient.

Abe Shimmelpenick: The other ones as well they all go away very quickly same goes for the headaches. So if you're one of the few people that actually notice a headache and again placebo corrected that was about seven 6%.

Abe Shimmelpenick: Same goes for the headaches. So, if you're one of the few people that actually notice a headache, and, again, placebo corrected, that was about 7.6% in our efficacy trials. So, if you're one of those few people that feel that,

Abe Shimmelpenick: Efficacy trials, so if you're one of those few people that feel that.

Abe Shimmelpenick: They classify this as very mild and something that goes away very quickly. So that may range patient to patient from 10 minutes, 20 minutes, to 30 minutes or maybe slightly more, but it is transient. So it goes away quickly. The data that we're trying to gather now is to see if it's tachycelectic. So over time, as you continue to use the product, it doesn't occur anymore after, for example, a week. So, this is interesting data to look at.

Abe Shimmelpenick: The classified Thats very mild and something that goes away very quickly. So that may range patient to patient from 10 minutes 20 minutes to 30 minutes or maybe slightly more.

Abe Shimmelpenick: But it is trends yet so it goes away quickly the data that we're trying to get it now is to see <unk> electric so over time as you continue to use the product.

Abe Shimmelpenick: That's just not even occur anymore. After for example, a week.

Abe Shimmelpenick: So this is interesting data to look at the interesting thing is that we only have very few patients which is good that had a headache.

Abe Shimmelpenick: The interesting thing is that we only had a very few patients, which is good, that had a headache. So, it makes it interesting to look at the data and see if we can find any trends. If we do, we will make sure to bring those up again at the KOL events in June.

Abe Shimmelpenick: It makes it.

Abe Shimmelpenick: Interesting to look at the data and see if we can find any trends. If we do we will make sure to bring those again to the kols events in June.

Operator: Okay. Great. Thank you for all the detail.

Speaker Change: Okay, great. Thank you for the detail.

Abe Shimmelpenick: And maybe, can you just speak to the issues with retinal detachment or some of the other products? And I know that's not something that came up in clarity, so hopefully, can you just talk about potential label implications? Absolutely.

Operator: And maybe can you just speak to retinal detachment for some of the other products.

Abe Shimmelpenick: I know it's.

Abe Shimmelpenick: Not something.

Abe Shimmelpenick: <unk> about priorities.

Abe Shimmelpenick: Hopefully.

Speaker Change: Can you just talk about potential label implications.

Abe Shimmelpenick: So let me answer the label, and I'll hand it over to Mark to explain how our product is different and why we feel we see the, again, very good lack of retinal attachments with cycadin. But from a label claim perspective, currently, we expect that the FDA will treat this as a class label effect. I think important it is that the data that we have, we can obviously share with healthcare providers. We'll definitely have that discussion with the FDA. But again, currently, we believe that we might have the same general label or class label effect as the other meiotics.

Speaker Change: Absolutely. So let me answer the label and I'll hand, it over to Mark to explain how our product is different and why we feel we see the again very good lack of rational attachments, what a cycle, but from a label claim perspective currently we expect that the FDA.

Mark: Treat this as a class label effects.

Mark: I think important is that the data that we have we can obviously shadwick.

Abe Shimmelpenick: <unk> will definitely have that discussion with the FDA.

Mark: But again currently we believe that we might have to same general label, a class label affects us CLO biotics, but again the product is a very differently artic and mark feel free to jump in and add to that.

Abe Shimmelpenick: But again, the product is a very different meiotic, and Mark, feel free to jump in and add to that. Thank you. Thank you for the question. The unique feature of a cichlidine is that it spares the ciliary muscle for the most part, and that means it doesn't cause constriction during a critical part on a critical part of the eye, and that constriction can cause a small amount of traction at something called the vitreous base.

Mark: Thank you Ed. Thank you for the question.

Mark: The unique feature of a secular dean is that it spares the ciliary muscle.

Mark: For the most part and that means it doesn't cause constriction during a critical part.

Mark: On a critical part of the eye and that.

Mark: Striction can cause a small amount of traction at something called the vitreous space. So that while this is very if you will inside the eye an inside baseball if I can use that analogy. This is something that this particular drug does not do and therefore.

Mark Odrich: So while this is very, if you will, inside the eye and inside baseball, if I can use that analogy, this is something that this particular drug does not do, and therefore, it has a very low likelihood of causing the same kinds of problems that you would see with the drugs that were more popular than this drug, such as pilocarpine and carbacol, which stimulate this ciliary muscle so that there is traction on this area. So it's a fundamental difference in our mechanism of action. We are a very specific myotic, which is pupil selective and avoids the ciliary muscle as a mechanism of action.

Mark Odrich: This has a very low likelihood of causing the same kinds of problems that you would see with the drugs that were more popular than this drugs such as pilocarpine in Carbachol, which in fact stimulate ciliary.

Mark Odrich: Ciliary muscle.

Mark Odrich: Is that there is traction on this area. So it's a fundamental difference in our mechanism of action. We are a very specific miotic, which is.

Mark Odrich: Its pupils selective and avoids familiarity muscle as a mechanism of action.

Operator: Thanks, Bob. Thanks, Bob. Thanks, Tim. And the last question comes from the line of Mark Goodman with Delirium Partners. Your line is open.

Speaker Change: Thanks, Bob for that.

Mark Goodman: Thanks, Tim.

Mark Goodman: And last question.

Mark Goodman: Comes from the line of Matt <unk>.

Mark Goodman: Your line is now open.

Operator: Hi, this is Batma speaking on behalf of Mark. We would like to ask a question about the survey results for the CLAR-G trials where you mentioned that 75% of the respondents mentioned that they would continue using Lenz 100. Do you know why 25%?

Operator: Yeah.

Speaker Change: Hi, This is Mike this is Bob.

Operator: Mike.

Batma: We would like to ask a question about the survey results performing larger trials, where you mentioned the 75% of respondents.

Batma: You mentioned that they will continue using all lines 100.

Batma: Do you know why 25%.

Abe Shimmelpenick: What was the factor that drove 25% to discontinue the drug? And along the same lines, do you think that this 25% is kind of an indicator of the discontinuation rates that you expect in the real world, or do you expect from the use of the drug? And do you actually have any data from market research or analysis from ongoing long-term safety data, a trial, I'm sorry, that can give you insight on the discontinuation rates? Thank you. Thank you. Thank you for your question. Very insightful.

Batma: Factors that drove 25% to discontinue the drug.

Abe Shimmelpenick: And along the same lines do you think that this 25% is kind of a fabricator of the discontinuation rates that you expect.

Speaker Change: In the real World or do you expect from the use of the Dragon.

Abe Shimmelpenick: And do you actually have any data from market research or analysis.

Speaker Change: Calling Walter Thank you Peter.

Speaker Change: And I'm, sorry that can give you insight on the discontinuation rate.

Speaker Change: Thank you.

Abe Shimmelpenick: Let me kick that off and then hand it over to Sean for some additional detail. First, just to make sure that, or to clarify, the question was asked after the study was completed. So patients had their last day of use of the product. We then asked them, if this were commercially available, would they want to continue to use the product? So, this is not a discontinuation rate from the study by any means.

Speaker Change: Thank you. Thank you for your question very insightful. So let me kick that off and then hand, it over to Sean for some additional detail.

Sean: Firstly, just to make sure that our to clarify so the question was asked after the study was completed so patients at the last day of use of the product. We don't ask them. If this were a commercially available would you want to continue to use the products.

Sean: This is not a discontinuation discontinuation rates and the study by by any means in fact, the vast majority of the applications of our participants completed both the.

Abe Shimmelpenick: In fact, the vast majority of the patients or the participants completed both the efficacy and the long-term safety studies. And, again, that plays to the product being very comfortable but also very effective.

Sean: Efficacy and the long term safety studies, and again that place to probably being very comfortable but also very effective.

Abe Shimmelpenick: So.

Abe Shimmelpenick: The 25% that you referenced are people that say, yeah, I notice an effect, but I might not use it, going forward. If it's in the real world, we feel can have a couple of different reasons. Maybe those are people that actually are happy with their current near-vision solution. So, these people are on bifocals, and they feel that that's the right solution for them, and they don't want to change that. That's maybe one reason.

Sean: The 25% that you reference people that say, yes, I noticed that effect, but I might not use it going forward. If it's in the real world. We feel can have a couple of different reasons. Maybe those are people that actually are happy with their current near vision solutions. These people on.

Abe Shimmelpenick: By focus and they feel that that's.

Abe Shimmelpenick: The right solution for them.

Abe Shimmelpenick: They don't want to change that that's maybe one one reason.

Shawn Olson: Another reason is that maybe they feel that this is a cost that they cannot afford. You know, those are some of the things that you can think about. But again, these are not reasons for discontinuing the product per se. But really, if this product were to be commercially available, would you use it? Yeah, and when I think commercially about this, I find it's very encouraging to see there are results, and we also see it in line with our general market research.

Abe Shimmelpenick: Another reason is maybe that feel that this is a cost that they cannot afford.

Shawn Olson: Some of the things that you can think about it but again these are not reasons off.

Shawn Olson: Discontinuation of the product per se, but really if this product to be commercially available would you use it.

Shawn Olson: And when I think commercially about this I find this very encouraging to see their results and we also see it in line with generally our market research and our.

Shawn Olson: In our corporate presentation, we highlight the interest in this drop, and generally, depending on the age, the amount of people that would seriously consider an eye drop like this rolls all the way up to about 68 percent. So seeing 75 percent continues after the study is exactly in line with what we expect from our market research. And again, very encouraging data. It's great to see such high numbers. And it also confirms that 81% of those people would expect to use it four to seven days a week. That's from the PROs.

Shawn Olson: Corporate presentation, we highlight the interest in this dropped and generally depending on the age the amount of people that would seriously consider and I dropped like this.

Shawn Olson: Rolls all the way up to about 68%. So seeing 75% continued after the study is exactly in line that we expect from our market research and again very encouraging data, it's great to see such high numbers and it also confirms that 81% of those people would expect to use this 4% to seven days a week that's from the <unk>.

Shawn Olson: That is almost exactly aligned with our market research, which came between 79 to 80% of those people being four to seven days a week. So what I find really encouraging is that we actually see that our actual outcomes from our phase three trial mimic what we're finding in our market research as well, which highlights the huge opportunity in this market. And I think as we go towards commercialization, if you think of the sampling strategy, that will really play into that refill rate, which I think is a better thing to focus on is that refill rate.

Shawn Olson: That is almost exactly in line with our market research, which came between 79% to 80% of those people being four to seven days a week. So I find really encouraging is we actually see that our our actual outcomes from R. R.

Shawn Olson: Phase III trial mimic what we're finding in our market research as well, which highlights the huge opportunity in this market and I think as we go towards commercialization. If you think of the sampling status strategy that will really play into that refill rate, which I think is a better thing to focus on is that refill rate.

Shawn Olson: You know, because we're going to have a strong sampling plan up front, that's going to allow people to try this product, make sure this is for them, which we expect the vast majority to do, and then move on into that, you know, fulfillment and repeat buying of the product. So we see that strategy is, you know, very important in actually improving this, you know, refill rate. Thanks, Sean.

Shawn Olson: Because we are going to have a strong sampling plan upfront thats going allow people to try this product make sure that fits for them, which we expect the vast majority to do and then move on into that fulfillment and repeat buying of the product. So we see that strategy is very important and actually improving this risk.

Sean: All right.

Abe Shimmelpenick: And maybe just the last point to add to that, if you were to pluck these percentages in against the 128 million population of residuals in the U. S., you end up with a market that's about 15 to 20 times higher than the $3 billion that we already forecast. So the $3 billion that we talk about as the market potential really takes a very conservative approach on which part of the 128 million population is ultimately going to use it, and how often are they going to use it. Thank you. That's very helpful.

Shawn Olson: Thanks, Sean and maybe just the last point to add to that if you were to pluck. These percentages and against the 128 million population of presbyopia in the U S.

Abe Shimmelpenick: You end up with a market that's about 50.

Abe Shimmelpenick: 15 to 20 times higher than the $3 billion that we already forecast so the $3 billion.

Abe Shimmelpenick: We talk about is the market potential really takes a very conservative approach on which part of the 128 million population is ultimately we feel going to use it how often are they going to use that it also I think indicates the end of very significant upsides over $3 billion.

Abe Shimmelpenick: Market that.

Abe Shimmelpenick: That you could see.

Speaker Change: Thank you that's very helpful. Thank you.

Speaker Change: Thank you.

Speaker Change: There are no further question at this time, Mr. Shimon Panic and turn the call back over to you.

Speaker Change: Thank you Amy.

Speaker Change: Thanks, everyone and thank you for taking the time to join us today.

Speaker Change: And we look forward to keep you updated and.

Speaker Change: We will see hopefully at the June event. Thanks, everyone.

Speaker Change: This concludes today's conference call you may now disconnect.

Speaker Change: Please wait the conference will begin shortly.

Abe Shimmelpenick: Yes.

Abe Shimmelpenick: [music].

Abe Shimmelpenick: Okay.

Abe Shimmelpenick: Sure.

Abe Shimmelpenick: [music].

Abe Shimmelpenick: Yes.

Abe Shimmelpenick: Yes.

Abe Shimmelpenick: Yes.

Abe Shimmelpenick: Yes.

Abe Shimmelpenick: [music].

Speaker Change: Ladies and gentlemen, thank you for standing by at this time I would like to welcome everyone to that instead of a few things first quarter 'twenty 'twenty four financial results and business update all lines have been placed on mute to prevent any background noise. After your speakers remarks, there will be a question and answer Sir.

Operator: Thank you. Thank you. There are no further questions at this time. Mr. F. Schimel Penning, I turn the call back over to you.

Speaker Change: If you would like to ask a question. During this time simply press star followed by the number one on your telephone keypad.

Operator: If you would like to withdraw your question again class the Starwood sale.

Speaker Change: Thank you.

Operator: I would now like to turn the conference over to Dan Chevrolet. Please go ahead Sir.

Abe Shimmelpenick: Thank you, Dimi. Thank you, everyone. Thank you for taking the time to join us today.

Dan Shovel: Thank you good afternoon, everyone and thank you for joining us today to discuss lenses first quarter 2024 financial results and business updates. My name is Dan shovel, our Chief financial Officer of lens Therapeutics. We are joined today by <unk> <unk>, our president and Chief Executive Officer, who will provide our busy.

Operator: We look forward to keep you updated and we'll see you hopefully at the June event. Thanks, everyone. This concludes today's conference call. You may now disconnect. Please wait. The conference will begin shortly. ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Ladies and gentlemen, thank you for standing by.

Operator: This update as well as Dr. Mark <unk>, Chief Medical Officer, and Sean Olson, Chief Commercial officer, both of whom will join us for Q&A.

Speaker Change: Before we begin I would like to remind you that this call will contain forward looking statements regarding lenses future expectations plans prospects corporate strategy cash runway projections and performance, which constitute forward looking statements.

Operator: 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 SEC.

Operator: 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.

Operator: At this time, I would like to welcome everyone to Lenz 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 the 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 Shevalait. Please go ahead, sir.

Operator: With that I'll now turn the call over to H.

Dan Chevallard: Thank you. Good afternoon, everyone, and thank you for joining us today to discuss Lenz's first quarter 2024 financial results and business update. My name is Dan Chevillard, Chief Financial Officer of Lenz Therapeutics. We are joined today by Abe Shimmelpenick, our President and Chief Executive Officer, who will provide our business update, as well as Dr. Mark Odrich, Chief Medical Officer, and Shawn Olson, Chief Commercial Officer, both of whom will join us for Q&A.

Dan Shevalait: Thank you Dan and thank you everyone for joining us today.

Dan Chevallard: 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, cash runway projections, and performance, which constitute forward-looking statements. However, 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 obligation to update such statements.

Abe Shimmelpenick: I'll start by saying that the first quarter of 'twenty four and the weeks following have been transformative for loans.

Abe Shimmelpenick: With that, I'll now turn the call over to Dan. 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 Lenz. In March, we completed our merger with Graphite.

Abe Shimmelpenick: Bio and a concurrent $53.5 million pipe financing. As a result, we became a public company trading on NASDAQ under the ticker Lenz. 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.

Dan Chevallard: In March we completed our merger with <unk> bio and a concurrent $53 $5 million pipe financing.

Abe Shimmelpenick: And as a result, we became a public company trading on NASDAQ under the ticker <unk>.

Abe Shimmelpenick: These transactions allowed us to be well capitalized with around $213 million of cash and cash equivalents at the end of the quarter on our balance sheet.

Abe Shimmelpenick: 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 Lenz and Graphite, as well as advisors on both sides that got us to a strong position. Only a few weeks after our public debut, we announced our positive Clarity Phase III data and selected LNZ100, a single-agent recycling product, as our commercial candidate to treat presbyopia.

Abe Shimmelpenick: Fortunately, we anticipate this cash balance to be sufficient to fund our operations to post launch positive operating cash flow.

Abe Shimmelpenick: I want to acknowledge the hot-work that wanted to enter this and thank the teams at both labs and gratifying.

Abe Shimmelpenick: Advisors on both sides that got us to a strong position.

Abe Shimmelpenick: Only a few weeks after our public debut we announced a positive clarity phase III data and selected LNG, one hundreds a single agent or cycling products as our commercial candidates to treat presbyopia.

Abe Shimmelpenick: 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.

Abe Shimmelpenick: 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.

Abe Shimmelpenick: As the crystalline lens is hottest with H is less able to accommodate and focus the incoming light for near vision on the retina, resulting in blurry near vision.

Abe Shimmelpenick: 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.

Abe Shimmelpenick: Although the progression of presbyopia is gradual presbyopia, often experience and a change in their daily lives as the symptoms become more pronounced starting in that mid forty's. When reading glasses are autocorrected eggs are suddenly necessary to read text will conduct close up work.

Abe Shimmelpenick: To address the daily challenges faced by <unk>, we are developing a once daily.

Abe Shimmelpenick: Pharmacological eye drop that has been shown to be capable of improving near vision throughout the full workday without the need for reading losses.

Abe Shimmelpenick: Before I give a brief summary of the positive clarity top-line data, I want to highlight that throughout the development of LMZ100, 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 higher 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.

Abe Shimmelpenick: Before I give a brief summary of the positive clarity topline data I want to highlight that throughout the development of LNG. One hundreds our objective has always been to commercialize the product that we believe will most effectively meet the needs of the widest range of presbyopia and best create loyalty.

Abe Shimmelpenick: And value based on all eyes, All day Brent mission.

Abe Shimmelpenick: That means that we're not only aiming for higher 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.

Abe Shimmelpenick: 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 age 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.

Abe Shimmelpenick: This is why we made sure that the close to 1100 participants and a clarity studies represented the majority up to 128 million passenger hopes in the U S alone.

Abe Shimmelpenick: We included participants.

Abe Shimmelpenick: 45% to 75 with a mean age of 55.

Abe Shimmelpenick: We also made sure to include people that had a wide range of effective Arris think of this as including people that need to wear contact lenses or glasses to correct that distance vision, but also people that have never had to wear and distance vision correction and alive.

Abe Shimmelpenick: 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 presbyopia. By doing so, we feel confident that the results that we generated truly reflect the potential benefits that LMZ100 can bring to the vast majority of the close to 2 billion Presbyopes globally.

Abe Shimmelpenick: We made sure to also include people that had previously undergone lasik and cataract surgery and.

Abe Shimmelpenick: And importantly, we included participants with a wide range of presbyopia to make sure that we have a product that can be.

Abe Shimmelpenick: Two mild moderate and severe <unk>.

Abe Shimmelpenick: By doing so we feel confident that the results of regenerate it truly reflect the potential benefits for the LNG 100 can bring to the vast majority of the close to 2 billion passenger hopes globally.

Abe Shimmelpenick: On that note, let's talk about the key outcomes of the Clarity Phase 3 study in which LMZ100, 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, focus on the results of the Clarity 2 trial as this is the direct vehicle control trial. LNZ100 showed a rapid onset with 71% 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.

Abe Shimmelpenick: On that note, let's talk about the key outcomes of the clarity phase III study in which LNG 100, a single agents are cycling product candidates continue to show strong performance and best in class potential.

Abe Shimmelpenick: Consistent with previous trials for a moment focusing on the results for the clarity to trial and this is this is the direct vehicle controlled trial <unk>.

Abe Shimmelpenick: LNG 100 showed a rapid onset with 71% of participants achieving three lines or more of near vision improvement without losing one lino more distance vision at 30 minutes on the very first day of use of the products.

Abe Shimmelpenick: At the primary endpoint of three outlets. We also observed a three line of more respond the rates of 71%.

Abe Shimmelpenick: LNZ 100 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 0.0001. We also saw a very impressive near-universal response to LNG-100, 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 breastfeeding operations.

Abe Shimmelpenick: LNG 100 also maintained high levels of near vision improvements with 40% of participants achieving three lines or more of near vision improvement at 10 Atlas. The last time point measured in our efficacy trials.

Abe Shimmelpenick: While our results were highly statistically significant with P values at each time point of less than <unk> Triple Zero luck.

Abe Shimmelpenick: We also saw very impressive near Universal response to LNG one hundreds.

Abe Shimmelpenick: With 95% of participants achieving at least two lines of near vision improvements.

Abe Shimmelpenick: This is an important measure because it is seen as clinically meaningful and significant for most possibly hopes.

Abe Shimmelpenick: Notably, 69% of the participants still reported this improvement at the end of the day, 10 hours after dosing. In both efficacy trials, Clarity 1 and 2, the participants used their assigned treatment agent every day for 42 days. We saw similarly high response rates for LNG100 across both trials on the various days we brought participants in for measurement. In terms of safety, LNZ100 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 non-serious adverse events, 95% were classified as mild, believed to be transient, and consistent with those observed in previous trials.

Abe Shimmelpenick: Notably 69% of the participants still reported there is improvement at the end of the day 10 hours after dosing.

Abe Shimmelpenick: And both the efficacy trials clarity wanted to the participants to use their assigned treatment agents every day for 42 days.

Abe Shimmelpenick: We saw a similarly high response rates for LNG, one hundreds across both trials at the various days, we brought participants and for measurements.

Abe Shimmelpenick: And so as a safety LNG 100, plus seem to be well tolerated with no treatment related serious.

Abe Shimmelpenick: Averse events observed and the over 30000 treatment days across all III clarity trials.

Abe Shimmelpenick: Although reported non serious adverse events, 95% booked classified as miles alluded to be transient and consistent with those observed in previous trials.

Abe Shimmelpenick: Commercial potential was further confirmed by a participant survey, with 90 percent of participants noticing an improvement in near vision, and 75 percent of them indicating that they would continue to use LMG100 after the study. Together with the broad inclusion criteria we mentioned earlier, we believe this positions L&Z 100 well for the estimated over $3 billion potential market opportunity. We recently received the full data sets of the three CLARI trials and are currently analyzing them for additional insight.

Abe Shimmelpenick: Commercial potential was further confirmed by participants service with 90% of participants noticing on improvement in near vision, and 75% of them, indicating that they would continue to use LNG 100 after the studies.

Abe Shimmelpenick: To get at what the broad inclusion criteria. We've mentioned earlier, we believe dispositions LNG 100, well for the estimated over $3 billion potential market opportunity.

Abe Shimmelpenick: We recently received the full data sets up to three clarity trials currently analyzing them for additional insights.

Abe Shimmelpenick: 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 the nearly universal high efficacy of LNG100. For example, looking at pooled data across both of our efficacy trials, clarity one and two, we see that not only did 97% of participants achieve at least a three-line improvement at some point, but an impressive 84% improved their near vision by at least four or more lines.

Abe Shimmelpenick: 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 a nearly universal high efficacy of LNG 100.

Abe Shimmelpenick: For example, looking at both data across both of our efficacy trials carrier wanted to we see that not only did 97% of participants achieve at least a three line improvement at some point.

Abe Shimmelpenick: But in an impressive 84% improve that near vision by at least four or more lines.

Abe Shimmelpenick: 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 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 3 results beyond the already shared top-line results. We're excited to announce that we're planning a Phase 3 Capstone KOL event on June 18. 2024 in New York City.

Abe Shimmelpenick: 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 EMEA of vision.

Abe Shimmelpenick: 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.

Abe Shimmelpenick: As mentioned, we are conducting analysis of the full dataset for phase III results <unk> already shared top line results.

Abe Shimmelpenick: We're excited to announce that we are planning a phase III capstone kols events on June 18th.

Abe Shimmelpenick: 2024 in New York City.

Abe Shimmelpenick: 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 clinical practice and the market, and first-hand experiences with LMZ100. 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 III study was designed in close alignment with the FDA, and the positive top-line data generated concludes the clinical development program for LNZ100.

Abe Shimmelpenick: 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.

Abe Shimmelpenick: For the clinical practice of markets and firsthand experiences with LNG one hundreds.

Abe Shimmelpenick: We look forward to providing additional information on these events in the weeks ahead.

Abe Shimmelpenick: Okay.

Abe Shimmelpenick: Turning to our upcoming NDA submission I am pleased to share that the clarity phase III study was designed in close alignment with the FDA and the positive topline data generated concludes the clinical development program for LNG one hundreds.

Abe Shimmelpenick: The team is now fully focused on the execution of the filing, and we are well on track to submit our NDA for LNG-100 to the FDA in mid-2014. In parallel to working towards our MBA submission, our commercial launch preparations are also well underway. In February 2024, Lenz launched its unbranded I am campaign to educate and excite eye care professionals about future presbyopia solutions. Over 40 key opinion leaders are involved in the campaign and are featured at IamSelected.com. That is P-Y-E-I-M-Selected.com, where eye care professionals can learn about ideal pupil size, iris muscle selectivity, and expected early adopters of presbyopia eye drops.

Abe Shimmelpenick: The team is now fully focused on the execution of the filing.

Abe Shimmelpenick: Well on track to submit our NDA for LNG, one hundreds to the FDA in mid 2014.

Abe Shimmelpenick: In parallel to working towards our NDA submission our commercial launch for Fatness is also well underway.

Abe Shimmelpenick: And February turned 24.

Abe Shimmelpenick: <unk> launched its unbranded campaign to educate and X sites eyecare professionals about future presbyopia solution.

Abe Shimmelpenick: Over 40 key opinion leaders are involved in the campaign and a feature at.

Abe Shimmelpenick: Selective okay.

Abe Shimmelpenick: That is D E and.

Abe Shimmelpenick: Selected dot com.

Abe Shimmelpenick: But I kept professionals kind of learn about ideal pupil size iris muscle cell activity and expected early adopters of presbyopia eyedrops.

Abe Shimmelpenick: To continue that momentum and to support the projected launch following potential FDA approval, Lenz is actively building out its U.S. commercial capability, 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.

Abe Shimmelpenick: Continuing on that momentum and to support the projected launch following potential FDA approval lenses actively building out its U S commercial capabilities.

Abe Shimmelpenick: Highlighted by completion of third party logistics contracting in the first quarter of 224, and the addition of key commercial expertise and direct to consumer and influenza marketing.

Abe Shimmelpenick: All in preparation for a potential launch of LNG, one hundreds as early as the second half of turning 25.

Abe Shimmelpenick: In summary, we are very pleased with the progress the team has made on all fronts.

Abe Shimmelpenick: The recent period has been and promises to continue to be a very exciting time at Lenz. With that, I'll hand it over to Dan, our CFO, for an update on our financial results. Thank you, Aif. As Aif mentioned, we're pleased with the successful close of the merger transaction and concurrent pipe, having ended Q1 with approximately $213.3 million in cash, cash equivalents, and marketable security, inclusive of the over $117 million acquired in the recent merger and the $53.5 million in proceeds from the concurrent private placement.

Abe Shimmelpenick: The recent period has been and promises to continue to be a very exciting time Atlanta.

Abe Shimmelpenick: With that I'll hand, it over to Dan.

Dan Chevallard: CFO for an update on our financial results.

Dan Chevallard: Thank you <unk> as <unk>.

Dan Chevallard: <unk> mentioned, we are pleased with the successful close of the merger transaction and concurrent pipe having ended Q1 with approximately $213 3 million in cash cash equivalents and marketable securities inclusive of the over $117 million acquired in the recent merger and to $53 5 million.

Dan Chevallard: And proceeds from the concurrent private placement.

Dan Chevallard: Importantly, we announced today that this is anticipated to fund the company's cash runway through to post-launch positive cash flow from operations. We believe this puts us in a strong position to focus on execution. Our operating results and resulting cash burn for the first quarter were substantially in line with our plan. However, as is common around transactions such as what we just completed, there have been, and will be into the second quarter, certain non-recurring or one-time transaction costs. Those aside, our total operating expenses, inclusive of both research and development and sales general and administrative expenses, for Q1 2024 were approximately $16.1 million, compared to $12.6 million for the same period

Dan Chevallard: Importantly, we announced today that this is anticipated to fund the company's cash runway through to post launch positive cash flow from operations.

Dan Chevallard: We believe this puts us in a strong position to focus on execution.

Dan Chevallard: Our operating results and resulting cash burn for the first quarter were substantially in line with our plan.

Dan Chevallard: And as is common around transactions such as what we just completed there have been and will be into the second quarter, certain nonrecurring or onetime transaction costs.

Dan Chevallard: <unk> aside our total operating expenses inclusive of both research and development and sales general and administrative expenses for Q1 2024 were approximately $16 1 million compared to $12 6 million for the same period in 2023.

Dan Chevallard: Overall, this increase was substantially a result of additional operating costs incurred in our preparations for being a publicly traded company and early commercial planning. More specifically, our research and development expenses for Q1 2024 were $10.5 million, which was materially consistent with research and development expenses of $10.3 million for the same period in 2023. Substantially, all research and development expenses incurred for these comparative periods related to the clinical development and manufacturing required to support our Phase 2 Insight and Phase 3 Clarity clinical trials. Selling general and administrative expenses for Q1 2024 increased to $5.6 million, compared to $2.3 million for the same period in 2023.

Dan Chevallard: Overall this increase was substantially a result of additional operating costs incurred in our preparations for being a publicly traded company and early commercial planning.

Dan Chevallard: More specifically our research and development expenses for Q1, 2024 were $10 5 million.

Dan Chevallard: Which was materially consistent with research and development expenses of $10 3 million for the same period in 2023.

Dan Chevallard: Substantially all research and development expenses incurred for these comparative periods related to the clinical development and manufacturing required to support our phase III insight and phase III clarity clinical trials.

Dan Chevallard: Selling general and administrative expenses for Q1, 'twenty 'twenty four increased to $5 6 million compared to $2 3 million for the same period in 2023.

Dan Chevallard: This increase was primarily driven by costs associated with preparations to be a publicly traded company, in addition to an increase in prelaunch commercial activities. As well, expenses in Q1 2024 included a non-recurring, non-cash, stock-based compensation charge associated with the merger. Finally, our net loss per share, both basic and diluted, was $3.53 per share in the first quarter of 2024 on a net loss of $16.6 million, compared to a net loss per share of $6.50 per share in the first quarter of 2023 on a net loss of $12.7 million. Please note that these loss per share figures consider only the weighted average common stock outstanding for the respective period.

Dan Chevallard: This increase was primarily driven by costs associated with preparations to be a publicly traded company. In addition to an increase in prelaunch commercial expenses.

Dan Chevallard: As well expenses in Q1 2024 included a nonrecurring noncash stock based compensation charge associated with the merger.

Dan Chevallard: Finally, our net loss per share both basic and diluted was $3 53 per share in the first quarter 2020 for on a net loss of $16 6 million.

Dan Chevallard: Compared to a net loss per share of $6 50 per share in the first quarter of 2023 on a net loss of $12 7 million.

Dan Chevallard: Please note that these loss per share figures considered only the weighted average common stock outstanding for the respective periods.

Dan Chevallard: And thus, most notably for Q1 2024, do not fully wait for any of, one, the convertible preferred and convertible common stock from pre-merger private Lenz that converted into common stock upon the merger closed, totaling 11.3 million shares. Two, the shares acquired from legacy Graphite shareholders as of the merger date, totaling 8.3 million shares, or three, the shares of Common Stock issued in the 2024 concurrent private placement totaling 3.6 More simply stated, we ended Q1 2024 with approximately 25.5 million shares of common stock outstanding, most of which were not fully weighted in our Q1 2024 net loss per share previously known.

Dan Chevallard: Thus, most notably for Q1 2024 do not fully weight any.

Dan Chevallard: One the convertible preferred convertible common stock from pre merger private lands that converted into common stock upon the merger close totaling 11 3 million shares.

Dan Chevallard: To the shares acquired from legacy graphite shareholders as of the merger date totaling $8 3 million shares or three shares of common stock issued in the 2024 concurrent private placement totaling $3 6 million shares.

Dan Chevallard: More simply stated we ended Q1 2024 with approximately $25 5 million shares of common stock outstanding most of which were not fully weighted.

Dan Chevallard: In our Q1 2024 net loss per share previously noted.

Dan Chevallard: Now as we advance from here, our allocation of capital will begin to change over the balance of the year, and we would like to take a moment to highlight the following three key items on this point. First, research and development and clinical development spend will decrease over 2024 due to the wind down of our positive phase 3 clarity study while prioritizing the financial support necessary to enable a successful mid-2024 NDA submission.

Dan Chevallard: Now as we advance from here our allocation of capital will begin to change over the balance of the year. So we would like to take a moment to highlight the following three key items on this point.

Dan Chevallard: First research and development and clinical development spend will decrease over 2024 due to the wind down of our positive phase III clarity studies.

Dan Chevallard: While prioritizing the financial support necessary to enable a successful mid 2020 for NDA submission.

Dan Chevallard: Second, we plan to allocate more emphasis and more capital toward the ramp-up of our commercial infrastructure and pre-launch activities over the balance of the year. And third, despite the non-recurring nature of our transaction-related costs, we will aim to maintain discipline in managing our general and administrative costs associated with being a newly publicly traded company.

Dan Chevallard: Second we plan to allocate more emphasis and more capital towards the ramp up of our commercial infrastructure and prelaunch activities over the balance of the year.

Dan Chevallard: And third eliminating for the nonrecurring nature of our transaction related costs, we will aim to maintain discipline in managing our general and administrative costs associated with being a newly publicly traded company.

Dan Chevallard: We look forward to executing on what is a clear path forward for the company towards NDA submission in mid-2024 and the potential approval and commercial launch of LMZ 100 in the second half of 2022. With that, I'll turn the call back over to you. Thanks, Dan. Operator, we're now happy to take questions. Thank you. The floor is now open for questions. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue.

Dan Chevallard: We look forward to executing on what is a clear path forward for the company towards NDA submission in mid 2024, and the potential approval and commercial launch of LNG 100 in the second half of 2025.

Dan Chevallard: With that I'll turn the call back over to <unk>.

Dan Chevallard: Thanks, Dan.

Dan Chevallard: We're now happy to take questions.

Dan Chevallard: Steve the floor is now open for <unk>.

Dan Chevallard: If you have dialed in we would like.

Dan Chevallard: To ask a question. Please press star one on your telephone Keypad Glacier had engender Keith.

Dan Chevallard: If you would like to withdraw your question simply press Star one again.

Operator: If you would like to withdraw your question, simply press star 1 again. Your first question comes from the line of Joseph Cantazzaro with Piper Sandler. Your line is open.

Dan Chevallard: Your first question comes from the line of Joseph Catanzaro with Piper Sandler Your line is open.

Operator: Hey, everybody. I appreciate you taking my questions. Maybe two quick ones from me.

Joseph Cantazzaro: Hey, everybody I appreciate you taking my questions, maybe maybe two quick ones from me.

Operator: First, on the NDA submission, can you maybe just help us better understand some of the gating factors there to getting that filing done? Is it mostly paperwork, or are there sort of other things going on in the background? And is there any risk of maybe timelines slipping there as you wait for some of those things to get done? [inaudible] And then second, maybe as we look towards the KOL event, are there any sort of additional analyses that you're performing within the clarity data sets and sort of maybe some new things we might expect to see at that June event and what could be important there? Thanks. Thank you; great questions. Let me take them.

Joseph Cantazzaro: First on the NDA submission can you maybe just help us better understand some of the gating factors there to getting that filing done is it mostly paperwork or are there sort of other things going on in the background and is there any risk to maybe timeline slipping. There you wait for some of those things to get done and then second.

Speaker Change: As we look towards the Kols event.

Speaker Change: Are there any sort of additional analyses that you are performing within the clarity datasets and sort of maybe some new things we might expect to see.

Speaker Change: At June.

Speaker Change: <unk> event and what could be important there.

Abe Shimmelpenick: So first one, as we work towards the NDA submission in the middle of the year, Like I said, we believe that with the clarity trials, we've now completed our full clinical program, and we have the final pieces of the clinical data in our hands. Over the years, we've been very well aligned, and we'll continue to be very well aligned with the FDA. So we have high confidence in the fact that we have a complete data set.

Speaker Change: Thanks, Joe Great questions let.

Speaker Change: Let me take them.

Abe Shimmelpenick: First one as we work towards the NDA submission.

Abe Shimmelpenick: The middle of the year.

Abe Shimmelpenick: So like I said, we believe that with the clarity trials, we've completed now.

Abe Shimmelpenick: Our full clinical program and we have the final pieces of the clinical data in our hands.

Abe Shimmelpenick: Over the years, we have been very well aligned and will continue to be very well aligned with the FDA. So we have high confidence in the fact that we have a complete data set.

Abe Shimmelpenick: And therefore, the team is now really fully focused on compiling the NDA. So, you know, to paraphrase what you were saying, it is paperwork from here on out. Doesn't mean that it's not a lot of work, and therefore the team is really focused on that. You know, we have the right people in place.

Abe Shimmelpenick: And therefore the team is now really fully focused on compiling the NDA so to paraphrase what you were saying.

Abe Shimmelpenick: It is paperwork from here on out.

Abe Shimmelpenick: I mean, there's not a lot of work and therefore the team is really focused on that.

Abe Shimmelpenick: You have the right people in place. So we're very confident that we will meet that submission timeline that we've guided to the middle or in the middle of 2024.

Abe Shimmelpenick: So we're very confident that we will meet that submission timeline that we've guided to the middle, in the middle of 2024. So, your second question has to do with the KOL event. Again, as we've mentioned on the call, we now have the full data sets of all our three studies, and teams on both sides are analyzing them for additional insight. What we're looking for and what we're starting to see is, you know, really interesting and exciting data around efficacy, you know, how does this product work for the different groups that are in the study. as it worked for mild, moderate, and severe presbyopia, any difference in response based on age, how the LASIK patients respond.

Abe Shimmelpenick: Okay.

Abe Shimmelpenick: So, those are some of the things that we're excited to share at the upcoming KOL event. And secondly, it's a great opportunity for, you know, people outside of Lenz to actually share their views on the data, how they see this working in the market. And as I've mentioned, we'll also have lead investigators from the CLARITY trial that have, you know, true first-hand experience with our product and, potentially, also with other products that will share their views on, you know, how it performed in that patient. Okay. Great! That's all super helpful. I appreciate you taking the time to answer my questions.

Abe Shimmelpenick: So second question is a sort of kols events.

Operator: Thanks. Thanks, Joe. The next question comes from the line of Egal Nokomovits with Citigroup. Your line is open.

Abe Shimmelpenick: Again, as we've mentioned on the call. We now have the full data sets.

Operator: Hi Ace and team, thank you so much. Ace, you mentioned some of the pooled data that you're looking at with the full data set. Is any of that potentially something that could make its way into the label language? Or is that more going to stay with the, you know, on the marketing claim front? No, great question, Igor.

Speaker Change: All three studies and teams.

Speaker Change: Teams on both sides analyzing them for additional insight.

Abe Shimmelpenick: Thanks for joining the call. So looking at the label, the label we actually expect to be fairly broad to begin with. So if you look at the duty label, it basically states for the treatment of presbyopia. So, you know, it's hard to expand that label.

Speaker Change: But we're looking for and what we're starting to see is really interesting and exciting data around efficacy.

Speaker Change: How does this work for the different groups that are in the study doesn't work for mild moderate severe presbyopia.

Speaker Change: Any difference in responds on H lasik patients respond. So those are some of the things that we're excited to share at the upcoming <unk> events and secondly, it's a great opportunity for people outside of lens to actually share that view on the data hub.

Abe Shimmelpenick: Now, on the label itself, you'll actually have data cutouts, and that's where the marketing team will continue to point at that. So we feel this is very important data to ultimately commercialize our product, but also for our healthcare professionals to look at and continue to gain confidence in how the product performs. So, again, we're very excited to see some early data cuts of that data, and as we continue to validate that, we'll start sharing that at our KOL event in June.

Abe Shimmelpenick: Thanks. And then, with regard to the filing of the NDA, I believe you were also on track to complete some of the stability studies for the product. Given that you're not taking Lenz 101 forward, but rather Lenz 101, is that any faster to finish that stability, or were both of those basically on the same timetable? Yeah, no; both were and are on the same timetable, as hard as I sometimes try to move times faster. That's obviously impossible.

Abe Shimmelpenick: So this work in the market.

Abe Shimmelpenick: As I've mentioned also also have lead investigators from the clarity trial that have true firsthand experience with our product and potentially also what other products that will share their views.

Abe Shimmelpenick: Howard plus outperformed and that patients.

Speaker Change: Okay, Great. That's all Super helpful. I appreciate you taking my questions.

Speaker Change: Thanks, Joe.

Abe Shimmelpenick: Next question comes from the line of Vega <unk> with Citigroup. Your line is open.

Speaker Change: Hi team. Thank you so much.

Abe Shimmelpenick: Thank you mentioned some of the pool data that youre looking at with the full dataset.

Abe Shimmelpenick: Is there any of that potentially something that could make its way into into the label language or is that more going to stay with the on the marketing claims.

Speaker Change: No great question Yigal. Thanks for thanks for joining the call. So looking at the label the label that we actually expect to be fairly broad to begin with so if you look at the view to label it basically states for the treatment of presbyopia.

Abe Shimmelpenick: So, yes, it's hard to expand that label.

Abe Shimmelpenick: And the label itself, you'll actually have data caught up so that's where the marketing team will continue and we will be able to point at that so we feel that it is very important data to ultimately commercialize a product, but also for our health care professionals to look at and continue to.

Abe Shimmelpenick: Gain confidence in our product performs so again very excited to see some early data cups of that data and as we continue to validate that.

Abe Shimmelpenick: We'll start sharing that at.

Abe Shimmelpenick: Okay.

Abe Shimmelpenick: Patents in June.

Abe Shimmelpenick: And then with regard to the filing of the NDA I believe you were also.

Abe Shimmelpenick: On track for completing some of the stability studies for the product.

Abe Shimmelpenick: Given that youre, not taking lens 101 forward, but rather 101.

Abe Shimmelpenick: Is that any faster to finish that stability.

Abe Shimmelpenick: Both of those basically on the same the same time timetable.

Abe Shimmelpenick: Yes.

Abe Shimmelpenick: On the same timetable.

Abe Shimmelpenick: Todd as I, sometimes tried to move times.

Abe Shimmelpenick: Mr.

Abe Shimmelpenick: So what truly is bound by the stability clock, and that is going into filing timing. And then just the last one on distance vision, you had some interesting data suggesting a potential benefit on distance. How much of that is going to be emphasized in your marketing pitch, or is that not going to really be the focus? I think, again, that that's going to be a great additional benefit.

Abe Shimmelpenick: That's impossible, obviously, so what truly bound body severity clock and that is going into a filing.

Abe Shimmelpenick: <unk>.

Abe Shimmelpenick: And then just the last one on the distance vision.

Abe Shimmelpenick: <unk> had some interesting data, suggesting a potential benefit on distance.

Abe Shimmelpenick: How much of that is going to be emphasized in your marketing pitch.

Abe Shimmelpenick: That's not going to really be the focus.

Abe Shimmelpenick: I think again that thats going to be.

Abe Shimmelpenick: Additional benefits so while it.

Abe Shimmelpenick: So while it's likely not going to be a label claim, that's not what we're striving for, it is data that we will aim to have included in the label, and therefore, the marketing team can highlight that. We do feel it's a very substantial benefit. One of the additional data cuts that we're looking at is, is there a certain population that notices this more than others or feels the benefit more? And one of the things that, again, anecdotally, we hear is that especially people that have previously had LASIK and know what 20-20 distance vision looks like, over time, they have lost a little bit, you know, back to 20-25 or 20-30, appear to feel that

Abe Shimmelpenick: It's likely not going to be a label claim is not what was driving for it is data that we will aim to have included in the label and therefore, the marketing team can kind of highlight that.

Abe Shimmelpenick: We do feel it's a very substantial benefit.

Abe Shimmelpenick: The.

Abe Shimmelpenick: Additional data costs that we're looking at is is there a certain population that notice this more than auto saw ill feel the benefit more in one of the things that again anecdotally, we hear is that especially people that have that previously had lasik.

Abe Shimmelpenick: And know what 2020 disciplines ratio looks like over time may have lost a little bit back to $25 2030.

Abe Shimmelpenick: Appear to feel that benefit so while it's not a label claim we feel it's definitely a benefit that is additive to the near vision effect. That's obviously the main driver of the upper level.

Abe Shimmelpenick: So while it's not a label claim, we feel it's definitely a benefit that is, you know, additive to the near vision effect. Okay, great. Thank you very much.

Abe Shimmelpenick: Okay, great. Thank you very much.

Operator: Thank you all. Thank you for the question and congratulations on all the products in the quarter. I know it's a very pivotal quarter for the company. My question is, can you talk about the transient nature of the adverse events that were observed in Clarity? I know I've heard some questions around the headache rates, but also, you know, when I look at it, maybe you can talk about that.

Abe Shimmelpenick: Thanks for your question comes from the line of Tim Lugo with William Blair. Your line is open.

Speaker Change: Alright. Thank you for the question and congratulations on all the progress in the quarter.

Operator: Alright pivotal quarter for the company.

Operator: My question is can you talk about the transient nature of the adverse events were observed and clarity.

Operator: I have heard some questions around the headache rates.

Operator: But also.

Operator: No.

Operator: When I look at it maybe you can talk.

Abe Shimmelpenick: Anything you're hearing from the market, because when I've seen some other successful eye care products, like Dry Eye, and then also maybe some other presbyopia products, the adverse event rate didn't compare well for clarity. So can you maybe speak to that a bit? Absolutely. Thanks, Tim, for that question. I think first and foremost, and then I'll get to the other adverse events, you know, the big thing that we're very pleased to see in our AE data is that across 30,000 patient treatment days, there were zero serious adverse events.

Operator: Any anything you're hearing from the market because of what I've seen in some other.

Abe Shimmelpenick: First of all I care products like dry.

Speaker Change: And then also maybe the other 10.

Speaker Change: DLP products, the adverse event rate in the compare well for clarity.

Speaker Change: Can you maybe speak to that a bit.

Speaker Change: Absolutely. Thanks, Thanks, Tim for that question so.

Speaker Change: I think first and foremost and then I'll get to the other.

Abe Shimmelpenick: <unk> events.

Speaker Change: The Big thing that we're very pleased with to C&I data is that across 30000 patient treatment days, there was zero serious adverse events. So I think thats that.

Abe Shimmelpenick: So I think that first and foremost speaks to what we believe the safety of the product and the profile of the product is, and it's obviously different than some of the other products that we've seen out there, and that's really, truly because of the difference in the mechanism of action of a psych event and how it does not stimulate the ciliary body. So if you don't look at the non-serious, treatment-related AEs, headaches, and some of the other ones that we've noticed, again, importantly, they're 100% or close to 100% are classified as mild.

Speaker Change: First and foremost speaks to what we believe the safety of the product and the profile of the product.

Abe Shimmelpenick: It is obviously different than some of the other products that we've seen out there.

Abe Shimmelpenick: <unk> truly.

Abe Shimmelpenick: Because of the difference of the mechanism of action of a cycle and how it does not stimulate subsidiary body.

Abe Shimmelpenick: So if you then look at the non serious.

Abe Shimmelpenick: Shipment related aes.

Abe Shimmelpenick: And some of the other ones that we've noticed again importantly, there are 100% or close to a 100% classified fight us mild so in general we see in the <unk>.

Abe Shimmelpenick: So in general, we see and the feedback that we get from patients is that this is a very highly tolerable product, very comfortable, with very minor AE issues. To your point, if you compare that to some of the other very successful products, our RAE profile is the same, or you could argue better than those products. You're asked whether they were transients.

Abe Shimmelpenick: Feedback that we got from patients.

Abe Shimmelpenick: This is a very highly tolerable products very comfortable with that.

Abe Shimmelpenick: Minor AE issues.

Abe Shimmelpenick: To your point, if you compare that to some of the other very successful products.

Abe Shimmelpenick: The profile is the same or you could argue better.

Abe Shimmelpenick: And then those products.

Abe Shimmelpenick: You asked whether they were transient.

Abe Shimmelpenick: So everything that we're seeing suggests that they are. So we obviously have done our Phase 2 trials. I have a lot of data there, and we're going through the data on our Phase 3 trials now. So, if you look at what's called insulation site irritation, that's basically, if you put an eye drop in your eye, some people feel a mild, very brief sting.

Abe Shimmelpenick: That we're seeing suggests that they are so we obviously have done a phase II trials have a lot of data that I will go into the data on our phase III trials now so.

Abe Shimmelpenick: Yeah, think of that as a blink or two, and that's gone. So, that's definitely transient. The other ones, as well, they all go away very, very quickly.

Abe Shimmelpenick: So if you look at the let's call an installation site irritation. That's basically if you put it an eye drop in your <unk>. Some people feel a mild very brief thing think of that as a blinker too and Thats gone. So that's definitely a transient.

Abe Shimmelpenick: The other ones as well they all go away very quickly same goes for the headaches. So if you're one of the few people that actually notice a headache and again placebo corrected that was about seven 6%.

Abe Shimmelpenick: Same goes for the headaches. So, if you're one of the few people that actually notice a headache, and, again, placebo-corrected, that was about 7.6% in our efficacy trials. So, if you're one of those few people that feel that, the classifier that's very mild, and something that goes away very quickly.

Abe Shimmelpenick: You can see trials, so if you're one of those few people that feel that.

Abe Shimmelpenick: The classified Thats very mild.

Abe Shimmelpenick: It's something that goes away very quickly so that may range patient to patient from 10 minutes 20 minutes to 30 minutes or maybe slightly more.

Abe Shimmelpenick: So that may range patient to patient from 10 minutes, 20 minutes, to 30 minutes or maybe slightly more, but it is transient. So it goes away quickly. The data that we're trying to gather now is to see if it is tachy-epilectic. So over time, as you continue to use the product, it does not even occur anymore after, for example, a week. So, this is interesting data to look at. The interesting thing is that we only had a very few patients, which is good, that had a headache. So, it makes it interesting to look at the data and see if we can find any trends. If we do, we will make sure to bring those findings again to the KOL event in June.

Abe Shimmelpenick: But it is trends yet so it goes away quickly.

Abe Shimmelpenick: Data were trying to get it now is to see <unk> electric so over time as you continue to use the product.

Abe Shimmelpenick: Not even occur anymore. After for example, a week.

Abe Shimmelpenick: So this is interesting data to look at the interesting thing is that we only have very few patients which is good that had a headache.

Abe Shimmelpenick: It makes it.

Abe Shimmelpenick: Interesting to look at the data and see if we can find any threats. If we do we will make sure to bring those again to the kols events in June.

Speaker Change: Okay, great. Thank you for the detail.

Abe Shimmelpenick: Okay. Great. Thank you for the follow-up detail. And maybe can you just speak to the issues with retinal detachment or some of the other products? And I know that's not something that came up in clarity, so hopefully, can you just talk about potential label implications? Absolutely.

Abe Shimmelpenick: And maybe can you just speak to the issues with retinal detachment of course, and we havent products.

Speaker Change: I know it's.

Speaker Change: Not something.

Speaker Change: About priorities.

Abe Shimmelpenick: Hopefully.

Speaker Change: Can you just talk about potential label implications.

Abe Shimmelpenick: So let me answer the label, and I'll hand it over to Mark to explain how our product is different and why we feel we see the, again, very good lack of retinal attachments with a psychodend. But from a label claim perspective, currently, we expect that the FDA will treat this as a class label effect. I think important it is that the data that we have, we can obviously share with healthcare providers. We'll definitely have that discussion with the FDA. But again, currently, we believe that we might have the same general label or class label effect as the other meiotics.

Speaker Change: Absolutely. So let me answer the label at all I'll hand, it over to Mark to explain how our product is different and why we feel we see the again very good blackout for ethanol attachments, what a cycle of it but from a label claim perspective currently we expect that the FDA.

Mark Odrich: Treat this as a class label effects.

Mark Odrich: I think important is that the data that we have we can obviously sherwood.

Abe Shimmelpenick: <unk> will definitely have that discussion with the FDA.

Mark Odrich: But again currently we believe that we might have to same general label, a class label affects us CLO biotics, but again the product is a very differently artic and mark feel free to jump in and add to that.

Abe Shimmelpenick: But again, the product is a very different meiotic, and Mark, feel free to jump in and add to that. Thank you. Thank you for the question. The unique feature of a cichlidine is that it spares the ciliary muscle for the most part, and that means it doesn't cause constriction during a critical part on a critical part of the eye, and that constriction can cause a small amount of traction at something called the vitreous base.

Mark Odrich: Thank you Ed. Thank you for the question.

Mark Odrich: The unique feature of a secular dean is that it spares the ciliary muscle.

Mark Odrich: For the most part.

Abe Shimmelpenick: That means it doesn't cause constriction.

Mark Odrich: A critical part.

Mark Odrich: On a critical part of the eye and that constriction can cause a small amount of traction at something called the <unk> space. So that while this is very if you will inside the eye in an inside baseball. If I can use that analogy. This is something that this particular drug does not do and therefore.

Mark Odrich: So while this is very, if you will, inside the eye and inside baseball, if I can use that analogy, this is something that this particular drug does not do, and therefore, it has a very low likelihood of causing the same kinds of problems that you would see with the drugs that were more popular than this drug, such as pilocarpine and carbacol, which stimulate this ciliary muscle so that there is traction on this area. So it's a fundamental difference in our mechanism of action. We are a very specific myotic, which is pupil selective and avoids the ciliary muscle as a mechanism of action.

Mark Odrich: Sure.

Mark Odrich: This has a very low likelihood of causing the same kinds of problems that you would see with the drugs that were more popular than this drugs such as pilocarpine in Carbachol, which in fact stimulate ciliary.

Mark Odrich: Ciliary muscle.

Mark Odrich: That there is traction on this area. So it's a fundamental difference in our mechanism of action. We are a very specific miotic, which is <unk>.

Mark Odrich: People selective and avoids the ciliary muscle as a mechanism of action.

Operator: Thanks, Bob. Thank you for that. Thanks, Tim. And the last question comes from the line of Mark Goodman with the Leering Partners. Your line is open.

Speaker Change: Thanks, Bob for that.

Mark Goodman: Thanks, Tim.

Mark Goodman: And last question.

Operator: Comes from the line of Mark Goodman with UBS your.

Mark Goodman: Your line is now open.

Operator: Hi, this is Batma speaking on behalf of Mark. We would like to ask a question about the survey results performed in the CLAR-G trials where you mentioned that 75% of the respondents mentioned that they would continue using Lenz 100. Do you know why 25%? What was the factor that drove 25% to discontinue the drug? And along the same lines, do you think that this 25% is kind of an indicator of the discontinuation rates that you expect in the real world, or do you expect from the use of the drug?

Operator: Hi, This is Matt this is Bob.

Operator: Mike.

Operator: We would like to ask a question about the survey results performing larger trials, where you mentioned the 75% of respondents.

Operator: Mentioned that they will continue using all lines 100.

Operator: Do you know why 25%.

Operator: The factors that drove 25% to discontinue the drug.

Operator: And along the same lines do you think that this 25% is kind of a theme.

Operator: <unk> of the discontinuation rates that you expect.

Operator: In the real World or do you expect from the use of the Dragon.

Operator: And do you actually have any data from market research or analysis from ongoing long-term safety data, a trial, I'm sorry, that can give you insight on the discontinuation rates? Thank you. Thank you. Thank you for your question. Very insightful. Let me kick that off and then hand it over to Sean for some additional detail.

Operator: And do you actually have any data from market research or analysis from an ongoing long term safety data.

Sean: And I'm, sorry that can give you insight on the discontinuation rate.

Operator: Yes.

Abe Shimmelpenick: So, first, just to make sure that or to clarify. So, the question was asked after the study was completed. So, patients on the last day of use of the product. We then asked them, if this were commercially available, would you want to continue to use the product? So this is not a discontinuation rate in the study by any means. In fact, the vast majority of the patients or the participants completed both the efficacy and the long-term safety studies. And again, that plays to the product being very comfortable but also very effective.

Operator: Thank you. Thank you for your question very insightful. So let me kick that off and then hand, it over to Sean for some additional detail so.

Abe Shimmelpenick: Firstly, just to make make sure that our to clarify. So the question was asked after the study was completed so patients at the last day of use of the product.

Abe Shimmelpenick: We then asked.

Abe Shimmelpenick: If this were a commercially available would you want to continue to use the products.

Abe Shimmelpenick: This is not a discontinuation discontinuation rates and the study by by any means in fact, the vast majority of the applications of our participants completed both the.

Abe Shimmelpenick: Efficacy in the long term safety studies, and again that place today, probably being very comfortable but also very effective.

Abe Shimmelpenick: So.

Abe Shimmelpenick: The 25% that you referenced are people that say, yeah, I notice an effect, but I might not use it, going forward. If it's in the real world, we feel can have a couple of different reasons. Maybe those are people that actually are happy with their current near-vision solution. So these people are on bifocals, and they feel that that's, you know, the right solution for them. They don't want to change

Abe Shimmelpenick: The 25% that you reference are people that say, yes, I noticed that effect, but I might not use it going forward if it's in the real world.

Abe Shimmelpenick: We feel kind of have a couple of different reasons, maybe those are people that actually are happy with their current near vision solutions. These people I on bifocals and they feel that that's.

Abe Shimmelpenick: The right solution for them.

Abe Shimmelpenick: They don't want to change that that's maybe one one reason.

Abe Shimmelpenick: That's maybe one reason. Another reason is that maybe they feel that this is a cost that they cannot afford. You know, those are some of the things that you can think about. But again, these are not reasons for discontinuation of the product per se. But really, if this product were to be commercially available, would you use it? Yeah, and when I think commercially about this, I find it very encouraging to see the results.

Abe Shimmelpenick: Another reason is maybe that feel that this is a cost that they cannot afford.

Abe Shimmelpenick: Some of the things that you can think about it but again these are not reasons off.

Abe Shimmelpenick: Discontinuation of the product per se, but really if this product to be commercially available would you use it.

Abe Shimmelpenick: And when I think commercially about this I find this very encouraging to see their results and we also see it in line with generally a market research and our corporate presentation. We highlight the interest in this dropped and generally depending on the age the amount of people that would seriously consider and I dropped like this.

Abe Shimmelpenick: And we also see it in line with our general market research. In our corporate presentation, we highlight the interest in this draft. And generally, depending on the age, the amount of people that would seriously consider an eyedrop like this rolls all the way up to about 68%.

Abe Shimmelpenick: Rolls all the way up to about 68%. So seeing 75% continues assessed after the study is exactly in line that we expect from our market research.

Shawn Olson: So seeing 75% continue to use it after the study is exactly in line with what we expect from our market research. And again, very encouraging data. It's great to see such high numbers. And it also confirms that 81% of those people would expect to use it four to seven days a week. That's from the PROs.

Shawn Olson: And again very encouraging data, it's great to see such high numbers and it also confirms that 81% of those people would expect to use this 4% to seven days a week. That's from the <unk> that is almost exactly in line with our market research, which came between 79% to 80% of this people being 4% to seven days a week. So I find really encouraging is we actually.

Shawn Olson: That is almost exactly aligned with our market research, which came between 79 to 80% of those people being four to seven days a week. So what I find really encouraging is that we actually see that our actual outcomes from our phase three trial mimic what we're finding in our market research as well, which highlights the huge opportunity in this market. And I think as we go towards commercialization, if you think of the sampling strategy, that will really play into that refill rate, which I think is a better thing to focus on is that refill rate.

Shawn Olson: You see that our our actual outcomes from our phase III trial mimic what we're finding in our market research as well, which highlights the huge opportunity in this market.

Shawn Olson: I think as we go towards commercialization. If you think of the sampling status strategy that will really play into that refill rate, which I think is a better thing to focus on is that refill rate.

Shawn Olson: You know, because we're going to have a strong sampling plan up front, that's going to allow people to try this product, make sure this is for them, which we expect the vast majority to do, and then move on into that, you know, fulfillment and repeat buying of the product. So that strategy is, you know, very important in actually improving this, you know, refill rate.

Shawn Olson: We're going to have a strong sampling plan upfront that's going allow people to try this product make sure that fits for them, which we expect the vast majority to do and then move on into that fulfillment and repeat buying of the product. So we see that strategy is very important and actually improving this refill rate.

Shawn Olson: <unk>.

Abe Shimmelpenick: Thanks, Sean. And maybe just one last point to add to that. If you were to pluck these percentages into the 128 million population of presbyopes in the U.S., you end up with a market that's about 15 to 20 times higher than the $3 billion that we already forecast. So the $3 billion that we talk about as the market potential really takes a very conservative approach on which part of the 128 million population is ultimately going to use it, and how often are they going to use it.

Speaker Change: Thanks, Sean and maybe just the last point to add to that if you were to pluck. These percentages and against the 128 million population of presbyopia in the U S.

Abe Shimmelpenick: You end up with a market that's about <unk> 50.

Abe Shimmelpenick: 15 to 20 times higher than the $3 billion that we already forecast so the $3 billion.

Abe Shimmelpenick: We talk about as the market potential really takes a very conservative approach on which part of the 128 million population is ultimately we feel going to use it how often are they going to use that it also I think indicates the end of very significant upsides over $3 billion.

Abe Shimmelpenick: Market that.

Abe Shimmelpenick: That you could see.

Abe Shimmelpenick: Thank you. That's very helpful. Thank you. Thank you. There are no further questions at this time. Mr. F. Schimmelpennig, I turn the call back over to you. Thank you, Demi. Thank you for taking the time to join us today. We look forward to keeping you updated, and we'll see you hopefully at the June event. Thank you, everyone. This concludes today's conference call. You may now disconnect.

Speaker Change: Thank you that's very helpful. Thank you.

Speaker Change: Thank you.

F. Schimmelpennig: There are no further question at this time, Mr. Shimon Panic and turn the call back over to you.

F. Schimmelpennig: Thank you Amy.

Speaker Change: Thanks, everyone and thank you for taking the time to join us today.

F. Schimmelpennig: And we look forward to keep you updated.

Abe Shimmelpenick: We will see hopefully at the June event. Thanks, everyone.

Abe Shimmelpenick: This concludes today's conference call you may now disconnect.