Good afternoon, and welcome to Lumos Pharma's Q2 2023 financial results conference call. Currently, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded. I will now turn the call over to Lisa Miller, Senior Director of Investor Relations. Thank you, operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements. Information presented on this call is contained in the press release we issued this afternoon and in our Form 10-Q, which may be accessed from the Investors page of the company's website. Speaking on today's call will be Rick Hawkins, CEO and Chairman, and Lori Lawley, our CFO. John McKew, our President and Chief Scientific Officer, as well as Dr. Pisit Pitukcheewanont, our Senior Vice President of Global Clinical Development and Medical Affairs, will join for the question and answer section. I will now turn the call over to Rick. Well, thank you, Lisa. Good afternoon, everyone. After the market closed today, we issued a press release announcing our Q2 2023 financial results and providing an update on our clinical programs. As is our practice, we'll keep our prepared remarks on today's call brief so we can maximize the time available for Q&A. I'll touch on the highlights from the quarter in recent weeks before turning it over to Lori for a review of our financial results. John McKew and Dr. Pitukcheewanont, or Dr. Duke, as we call him, will join us to answer your questions. Dr. Duke joined us about a year and a half ago from Ascendis, where he worked on their long-acting injectable growth hormone therapy or therapeutic to approval. He is also president of the Human Growth Foundation, and with his contacts and understanding of the potential of an oral therapeutic in this space, Duke has been instrumental in advancing the enrollment in our OraGrowtH210 trial and in the preparation for our phase III trial in pediatric growth hormone deficiency, or PGHD. Let's begin. As reported this afternoon, during our Q2 of 2023, we made continued progress in advancing our oral therapeutic candidate, LUM-201, in moderate idiopathic PGHD. We can confirm our expectation to report primary outcome data on up to 82 subjects in the dose range-finding OraGrowtH210 trial and up to 22 subjects in a mechanistic PK/PD OraGrowtH212 trial in the Q4 of 2023. At this point, I'd like to remind everyone about our expectations for the primary readout. The primary endpoint for these trials is annualized height velocity, or AHV, at six months on treatment. Based on historical data, the predicted growth rate for LUM-201 is between 8.3 cm and 8.6 cm per year for this moderate idiopathic PGHD population, according to observed growth in several large historical databases. The other objectives of the OraGrowtH210 trial are to confirm the utility of the predictive enrichment marker, or PEM strategy, and to determine the optimal dose for a phase III trial. We also expect our primary outcome readout to include AHV data at 12 months on treatment for up to 12 subjects per OraGrowtH210 cohort, and up to seven subjects for OraGrowtH212 cohort, for a total of up to 62 subjects from both trials. Additional AHV data at 18 and 24 months on treatment are also expected for a small number of subjects. In addition, the phase II trial should demonstrate a safety profile comparable, comparable to the daily growth hormone control arm. Also, as is the case for all phase II trials, the OraGrowtH210 trial is not powered to show non-inferiority of annualized height velocity between LUM-201 and the control arm, but should inform the design of and dose selection for a successful registration phase III trial. As a reminder, the non-inferiority margin between the treatment arm and the control growth hormone arm for a pivotal phase III trial in this indication has historically been from 1.8 to 2 cm a year at 12 months on treatment. This has held true for recent approvals of long-acting growth hormone products as well. The next steps in the program, we're obviously engaging in meticulous planning for a phase 3 trial. After a thorough review of the data package, the first step will be to request an End-of-phase II meeting with the FDA to review the phase II results and agree upon the ultimate design of the phase III trial. Based on regulatory precedents, we expect that this registrational trial will include approximately 180-200 PEM-positive subjects, randomized 2 to 1 versus growth hormone, with a likely dose of 1.6 mg/kg of LUM-201 to daily growth hormone stratified by age and other factors to ensure balanced cohorts. Our proposed primary endpoint will be AHV at 12 months on therapy. The trial will utilize the new LUM-201 formulation, for which we filed a novel formulation patent application last November, enabled by unique properties of our compound, which could extend our IP protection to 2042. This formulation of LUM-201 consists of mini-tablets in capsules, which we believe will provide an easier oral dosage form for the wide age range of our target population. We expect to hear from the US Patent Office later this year. Currently, LUM-201 has patent protection through 2036, plus applicable extensions for the detection and treatment of growth hormone deficiency, as well as orphan drug designation, which offers extended protection for up to 7.5 and 12 years from the date of drug approval in the US and Europe, respectively. During the quarter, we were pleased to see further data and analysis from these two trials presented at the 2023 Endo meeting. Data from these two abstracts were presented, including new data from the OraGrowtH212 trial that showed an increase in IGF-1 levels on LUM-201 at 6 months that remained within normal range, an increase in IGF-1 SDS greater than 0, and a durable growth response up to 12 months of LUM-201 administration. This clear evidence of potential drug effect for LUM-201 was also observed in consistent improvement in AHV over baseline. Also, new analysis of combined OraGrowtH210 and OraGrowtH212 trial data at the 1.6 and the 3.2 mgs per kg a day dose levels in 15 subjects from the OraGrowtH212, 20 subjects from the OraGrowtH210. These combined results continue to demonstrate that there is a durable response to LUM-201 from 6 to 12 months, at the 1.6 and 3.2 mgs per kg a day doses are comparable in the growth each stimulated. As many of you know, these data were highlighted in a key opinion leader webinar we hosted on June 21st, where Doctors Fernando Cassorla and Michael Tansey shared their insights on the data and their continued convictions in the potential of LUM-201 to become the first oral therapeutic to address this patient population treated solely by injectable therapies for the last 40 years. If you've not seen the webinar, we encourage you to review the replay, which is still available on our website. Additional analysis of data from the OraGrowtH212 trial was accepted as a late-breaking abstract for oral presentation at the upcoming annual meeting of the European Society for Paediatric Endocrinology, or ESPE, which was held in The Hague in the Netherlands, September 21 to 23. This abstract by Fernando Cassorla will include a deconvolution analysis of growth hormone secretion with LUM-201 administration and the moderate PGHD population. Now turning to other developments. We continue to support our clinical collaboration with Dr. Laura Dichtel in Massachusetts General Hospital, to explore the potential of orally administered LUM-201 in non-alcoholic fatty liver disease, or NAFLD. Positive results from this investigator's prior trial evaluating injectable growth hormone in NAFLD were recently published in the Journal of Clinical Endocrinology and Metabolism. It was these compelling data that encouraged Dr. Dichtel and Mass General to initiate the collaboration with Lumos Pharma to assess oral LUM-201 in the same indication. In the prior study, investigators hypothesized that growth hormone might reduce hepatic steatosis, or fat buildup in the liver, in obese patients with NAFLD. Subjects were randomly assigned to a treatment group, 27 growth hormone and 26 to the placebo group, with 41 completers overall, 21 growth hormone, 21 on placebo at 6 months. Reduction in absolute percent of intrahepatic lipid content by proton magnetic resonance spectroscopy was significantly greater in the growth hormone versus the placebo cohorts. Investigators concluded that growth hormone reduces liver fat without commensurate weight loss. These data are supportive of evaluation of oral LUM-201 in the NAFLD indication. The LUM-201 pilot trial in NAFLD continues to enroll. As a reminder, the company's primary near-term focus remains on advancing LUM-201 in PGHD. Now, as previously mentioned, we believe that LUM-201 has the potential to address about 10 other indications currently treated by injectable growth hormone. We've done a lot of work internally to assess the potential of LUM-201 in other indications and different geographic regions worldwide. As we've said before, we narrowed our focus to idiopathic short stature, or ISS, and Prader-Willi syndrome, where we see a sizable opportunity both in the US and internationally. While we assess these opportunities, we remain committed to the prudent use of our cash and ensuring our capital allocation is focused on advancing our core program. With that, I'm going to turn it over to Lori for a review of our financial results. Lori? Thank you, Rick. Lumos Pharma ended the quarter on June 30, 2023, with cash, cash equivalents, and short-term investments totaling $50.9 million, compared to $67.4 million on December 31, 2022. We reiterate our expectation for average cash use of approximately $9.5 million to 10.5 million per quarter through 2023. Cash, cash equivalents, and short-term investments as of June 30, 2023, are expected to support operations through at least the next 12 months from the date of the filing of our Q2 2023 financial statement, which is well beyond our announcement of top-line phase II trial results in the Q4 of 2023. This guidance is inclusive of estimated costs to be incurred in preparation for a phase III trial, including estimated costs for clinical trial site initiation, contract manufacturing expenses, and regulatory expenses. These costs may change depending on the primary data from the OraGrowtH210 trial and subsequent feedback from regulatory agencies. Research and development expenses increased by $1.4 million for the 3 months ended June 30, 2023, compared to the same period in 2022, primarily due to increases of $1.1 million in contract manufacturing expenses, $0.4 million in clinical trial expenses, and $0.1 million in personnel-related expenses, offset by a $0.2 million decrease in consulting expenses. General and Administrative expenses increased by $0.5 million for the 3 months ended June 30, 2023, compared to the same period in 2022, primarily due to increases of $0.2 million in personnel-related expenses, $0.1 million in stock compensation expenses, $0.1 million in travel expenses, and $0.1 million in royalty expenses. The net loss for the quarter ended June 30, 2023, was $8.9 million, compared to a net loss of $7.8 million for the same period in 2022. We ended Q2 2023 with 8,041,345 shares. With that, I will turn the call back to Rick to conclude for us. All right. Thank you, Lori. To recap, we can confirm our plan to report top-line data from both OraGrowtH210 and OraGrowtH212 trials in the Q4 of 2023. New interim data analysis presented at Endo and other medical meetings this year further reinforce our confidence that primary outcome data from these two OraGrowtH trials should achieve the predicted annualized height velocity at 6 months on treatment, in line with historical averages of 8.3 to 8.6 centimeters a year for this moderate idiopathic PGHD population. Though our phase II trials are not powered to show non-inferiority, primary outcome data from these trials should support selection of the LUM-201 dose for a registrational phase III trial, where non-inferiority to growth hormone of approximately 1.8 to 2 centimeters, centimeters should determine success based on historical approvals. Our novel formulat`ion of ORALGROW201 should also facilitate adherence to treatment protocols in both this pivotal trial and in the commercial setting, and if a new patent is granted, will extend IP protection beyond our current 2036 expiration date. We believe oral LUM-201 represents a platform therapeutic with the potential not only to disrupt the current worldwide $3.5 billion growth hormone market treated by injectable growth hormone products, now, that excludes China, which is also another $1 billion, but also to expand the market by increasing the historically low compliance and treatment rates due to the high burden of current injectable therapies. Additionally, we will continue to explore utility in broader indications such as NAFLD, where initial clinical studies have shown growth hormone treatment to be beneficial. In the near term, we're focused on advancing our clinical programs in PGHD, and we have the capital to support that effort well beyond our primary outcome readout later this year. Finally, in September, we plan to host both a KOL panel webinar and a KOL dinner, where noted pediatric endocrinologists will discuss their experience with PGHD patients, the therapeutic landscape, and the potential for an orally administered therapeutic to address other indications currently treated by injectable growth hormone. We're excited to continue to advance our clinical programs and look forward to disclosing top-line data in the Q4 of 2023. Thank you very much for your time today, and operator, we're ready to take questions. Thank you. The lines are now open for questions. To ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question is from Yasmeen Rahimi of Piper Sandler. Your line is now live. Good afternoon, team. Thank you so much for all the updates. I guess, could you maybe comment on how soon post the OraGrow readout you could be in a position to kick off the phase III studies? Maybe also some color on if you've started warehousing patients for the phase III, and help us around, you know, enrollment timelines? Third, when do you hope to get color in regards to patents, the patents that are filed with the new formulation? Appreciate color on those topics. Thank you again. Yep. John, I'm gonna let you answer that, the, the first question that Yaz asked. Yes, right, you know, right now we're, we're focused on thinking through all the steps to get from, you know, the data readout in the fall all the way out to the, you know, the End-of-phase II meeting and agreement with the FDA on our, our phase III protocol, right? There's, you know, there's a lot of work involved there in integrating the data from these 2 studies, you know, making any necessary adjustments to our phase III clinical plans, putting together that briefing book, you know, waiting the, the, the 60 days to get the meeting, and then, you know, hopefully quickly coming to agreement with FDA on what that phase III protocol is gonna look like. Really from then is when we'll start to kick off really the extent of our focus on, on, you know, bringing trial sites up and getting ready to go. We've, we've done a lot of the phase III prep work as, as much as we can. We're working on that right now, but we really need to get that, you know, that final agreement on the protocol really to start kicking things off and, you know, getting, getting sites to be thinking about patients. Remember, the patients that we need are naive to treatment and, and so, you know, it's a little bit early right now to, to, you know, you can be watching patients, but I think going any further than that, we, we'd wanna hold off on. In terms of the patent, we filed this patent in November of last year, right? You know, a 12-month decision time is, is not. It's kind of an expected times, timeline for when we might hear back on, on that patent. Yeah, Yaz, let me, let me just add, you know, we have an obviously a really experienced clinical development team. We've really performed well in this, the OraGrowtH210 and OraGrowtH212 trials and the extensions of those trials, in terms of time to enrollment, and I think that is due to two things. Number one, you know, a highly experienced, motivated staff has really managed these trials quite well. The second thing is that, you know, there is a lot of interest. Most of these experienced investigators have been working their entire careers with injectable products. This is the first time that an oral product for PGHD has shown up, so they're pretty excited to work with us, so we get a lot of attention. I might add one other point, and that is you know, you think about the typical time that it takes to enroll a full, you know, 180, 200 patients, Historically, you look at the companies who have done that in the long-acting space, you know, they were all enrolling in a phase III in competition with each other. They're finished with those studies. They're either obviously, those products are approved. While we certainly expect there's gonna be some competition for these patients, we believe there's gonna be a lot less than there was before. Therefore, we think enrollment is gonna go well. I maybe I'd just ask Duke to comment here because, you know, he's really been instrumental in his connection with all these, these, highly experienced sites. Thank you, Rick. Let me touch base with the timeline and enrollment, which is, again, most of the phase III trial, that's one of the big, big hurdle that most companies have experienced, right? With my connection with the KOL around the world, with experience they have done in the past, we hope that if we actually have well-prepared site initiation and potentially could start up site enrollment across the world as pretty much as the same timeline, we'll be able to cut down the number of recruitment and timeline or complete enrollment. Again, a lot of factor involved, but we will do our best based on strategic planning, as John had mentioned. Got it. Thank you- Yaz, did that answer your question? In the queue. Yeah, that was very helpful. Thank you, team. Thank you, Yaz. Thank you. One moment please, for the next question. Our next question is from Leland Gerschel of Oppenheimer. Your line is now live. Hi, guys. Thanks for taking my question and for the comprehensive framing of how to think about things as we head into the readout later this year. Couple questions from me. First, with respect to, obviously, you know, as we look forward to the data from OraGrowtH210 next quarter, wondering if you'd be able to share the PEM screening results or give any color to whether that's the rates of success you've been seeing with the PEM screening have aligned with your expectations? Then 2, as we look forward to the ESPE conference, you mentioned there'd be some additional analyses of the prior study. Just wondering if you could share what the nature of those additional analyses might be. Thank you. All right, John, do you wanna start with the PEM and the SB analysis? ... Sure. Thanks for the question, Leland. The PEM test has been very effective in, in, you know, as an inclusion criteria in the OraGrowtH210 study. We've spent a lot of time educating the clinicians in that study as to which subjects to screen to bring into the trial, and our success rate at inclusion is actually quite high, right? We've, we've got, you know, you know, we had originally said in the entire population, about two-thirds of the kids would be PEM positive. We're actually seeing a much higher number of tests returning a positive value simply because of how the clinicians are focusing their efforts and looking for patients, right? Looking towards the more moderate end of the spectrum, and kids who kind of fit the, the criteria of, of that slice of the patient population. We're getting, you know, a very high number of kids who are PEM positive versus what you would expect from just looking at the epidemiology data of the, you know, the whole spread of growth hormone deficiency. The, the second question about the Endo, the, the ESPE meeting. We've, you know, we've, given out the, the title about the deconvolution analysis of the 212 study. Essentially, it's focused on the 212 study and, and, you know, deconvolution of the PD data that, that is there. Those abstracts haven't been published yet, but the, you know, the, the program has been announced. I think we'll have to wait until they publish the abstract to get, a little bit more information about what's gonna be released there. You know, the, from the, from the title, that should give you a good sense of what's in there. Great. Thanks, thanks so much for taking the questions. I look forward to the updates. Thanks for the question, Leland. Thank you. One moment, please, for the next question. Our next question is from Ed White of H.C. Wainwright. Your line is now live. Hi, thanks for taking my questions. Just going back to the phase III study, and this might be difficult to answer, but how are you thinking about the number of sites that you're going to need for the phase III to enroll that 180-200 patients? How is the split going to go between US sites and ex-US sites? How are you thinking about the patient population? Same question, US versus outside the US. John, you wanna start? We, we haven't released the total number of sites. We're kind of deep in discussions with CROs and trying to get their input, you know, on what, what they've seen in the past. You know, obviously, we're reviewing what some of the folks in, in these successful long-acting programs have done. We haven't really, we haven't decided on a, a, a firm decision on the number of sites. Obviously, we are gonna do a global trial, as we've talked about. I think it's important. You know, we do expect to get different recruitment rates in different regions, you know, depending on access to growth hormone. I think we have to put all those together. In terms of what the FDA wants, obviously, I think we can certainly use, you know, almost all the US and European sites are quite acceptable. I think, you know, some of the Asian countries have, you know, requirements for which patients have to be, have to be or what number of patients have to be enrolled. I think we're working through all those, those spots right now. We don't have a final plan yet, but they are all things that we're thinking through. Yeah, let me just continue with that. Ed, you know, the benefit of being on the podium at all of these Endocrine meetings, around the world, is that all these experienced investigators have really attended those, those meetings, with, with a great deal of interest because of, of us being a first oral. The result is that I think more and more people are becoming real believers in what we're doing, and they've been reaching out to us and, and offering to be, you know, clinical sites. I don't think there's gonna be, you know, a, a problem in choosing, the sites. In fact, we have the benefit of more recent historical, entry rates from, from recently, just completed trials, you know, by site. Duke, of course, has a great deal of experience in that. I think that's gonna be much to our benefit. Yeah. Thanks, Rick. Perhaps a, a question on, you know, what's next for the company. You had mentioned the next indications are ISS and PWS. How should we be thinking about that? Are you prepared to run, you know, perhaps a phase I study concurrently with a phase III study that we've just been discussing, or will this be something that you're thinking about post phase III data? You know, Ed, I, I think that the answer to that question is, you know, we, you know, if we were a large company, we'd probably have a different plan. Capital markets are what they are. You know, as we go out and, and, and, and, and do all the advanced planning for our phase III, that's where we're gonna be focused. If the capital markets are going to permit us to raise the appropriate amount of money over time, then, then we're gonna start programs, other programs perhaps sooner than we normally would plan them. In addition to that, typically what happens when companies in their development plans get to this stage at the end of phase II, end of phase III, you know, regional partners show up, or at least partners of all types. As you know, I think our, our head of business development is a pretty busy guy at this stage, and we're gonna, I think, have some choices here, for some, to look at some partners who could help us advance the program. That could be in other indications, too, although, we certainly haven't, haven't had those discussions with anyone yet. Great. Thanks, Rick. Perhaps a question for Lori. Just when thinking about R&D, moving into the back half of the year, you mentioned that $1.1 million in commercial contracting expenses, hitting in the quarter. That's, I, I take it, a one-time event, and we should be thinking about the run rate more like the Q1? I, I think, you know, our, our research and development expenses for, for Q2 are, are pretty, you know, pretty on par with what we should expect, Leland, going forward. Not, not just in contract manufacturing expenses, but also in clinical. And recall that we are comparing this to 2022, and a lot of the efforts in 2023, you know, are going towards working to prepare for a phase III clinical trial. So R&D, we expect overall R&D and G&A operating expenses to be between. Okay. Thanks, Lori. Thank you everyone for taking my questions. Thank you, Ed. One moment please, for our next question. Our next question is from Catherine Novack of Jones Trading. Your line is now live. Hi. Good afternoon, everyone. Just a question on some KOL issues. You know, what we've heard time and again is that their real focus in, in PGHD is, you know, 12, 24 months and beyond. Here we tend to see injectable growth hormone attenuate after about the first year. So given the mechanism of action, is it safe to say you wouldn't expect this to be so dramatic with LUM-201? Then, you know, how should this change our expectations for what we should see in the data in phase II and phase III? Yeah. Well, thanks for that excellent question, Catherine. John, will you answer that? Sure. Two things to keep in mind. The phase III study will be a 12-month study, and so kind of the key decision point for that phase III will be non-inferiority at 12 months. Obviously, we have several ongoing trials now that are longer than 12 months, right? We'll, you know, hopefully, keep as many kids as we can in that trial and transition kids from the phase III into an extension trial as well. We will have a body of data on treatment past 12 months, but it won't be as comprehensive as the data we have at 6 and 12 months. That's the same data package that all the long-actings have brought in. You know, that said, you can look at the difference in growth, or look at the difference in annualized height velocity for individual patients between, you know, at 6 months, at 12 months, at 18 months, and look at the slope of that decline. As you said, it's, it's well documented, you know, that growth hormone has its kind of biggest peak in the 3 to 6-month range, and then, you know, every, every year after that, you get a decline. You don't get the same growth every year, right? You get a decline in return. You know, LUM-201 has been shown in adults, it's been published in adults, that you can elevate IGF-I growth hormone levels out to 24 months, right? In adults, that change body composition, we get that same level of continued elevation. In kids, we would expect to see a continued growth, right? I think some of the early data that we're gonna reveal at the end of this year on a handful of kids past 12 months will really start to help put those pieces together for us. There are certainly scenarios where you could expect, you know, that we're gonna modulate kids to a more natural growth pattern, that could be a much flatter growth slope than what you might see with kind of the pharmacological or supraphysiological levels of injectable growth hormone. Thank you for that question. Got it. Yeah. Yeah, of course. Just one more, you know, now that we've got a couple weekly injectables in the market for PGHD, you know, what kind of feedback are you getting from KOLs, or what are you hearing? How excited are they to use them, and does this factor into your LUM-201 market expectations at all? You know, Catherine, look, there's, there's no question that, that this is gonna be a highly competitive space. You look at the price on a monthly basis between the three growth hormone, long-acting growth hormones, there's something like $7,000, $8,000, and $9,000 per month, you know, all the way, you know, to yearly cost of over $100,000 for a 35-kilo kid. That's expensive treatment. I think there are, you know, there are certain parts of the world where the standard of care is gonna continue to be a daily because of the restriction in price. Or longer time to approvals in different markets around the world. We believe, I mean, we, we've done our market research. We've asked the question both to ped endos and to parents, "If you had a choice between a weekly injection or a daily oral?" They overwhelmingly say they would, they, they would, choose a daily oral. On top of that, I'm gonna remind you, we're a small molecule. Our cost of goods and our flexibility in pricing and, and margins, is, it looks very favorable to us long term in this market. Well, Kathleen, may I add with the feedback from the KOL industry experts? Yeah. Rick mentioned about the pricing. That's a very important, right? It's more expensive than daily. The other issue that the KOL have some skeptical is the safety data profile. As you know, that in order to get approved FDA, you only have 12-month safety data. However, long-term safety, especially long-acting, not only look at efficacy itself, the long-term side effect, which is again, you know, it's very unclear at the short term, right? When you look at, you know, profile, the growth hormone exposure for weekly growth hormone, it's much higher than daily growth hormone and also higher IGF-1. With that said, you know, long-term, post-phase IV study and postmarketing study need to continue in order to show off the safety profile in the long-term fashion. That's something that some KOLs still quite skeptical to really put all subject in weekly growth hormone therapy in regards to efficacy itself, right? Not to mention, it's very expensive. Yeah, Catherine, recall, you know, our mechanism, mechanism of action is very different from growth hormone. You know, we stay within the natural Endocrine feedback loop, and those excursions you get with, with, of higher levels of growth hormone, with, especially the long-acting, is not possible with our drug. once again, that feedback loop, is, it stays within the natural phy, physiology. Great. Okay, that, that's answered my question. Thanks very much. Thanks. One moment, please, for our next question. Our next question is from Pete Stavropoulos of Cantor Fitzgerald. Your line is now live. Hi, Rick and team. Nice to see all the progress made this quarter and movement towards data readout by year-end. A question, first question is, you know, when, when you look at the data that you've generated to date, you know, using the PEM, the predictive enrichment marker, and the growth that you've observed in these patients, you know, just curious to know, as you move into a later, larger study, you know, if, if you expect to keep the cutoffs where they currently are, or do you think, you know, you can increase the probability of success by focusing or, or enriching patients with a, with a greater response, you know, or is the current algorithm sufficient? Okay. Pete, thank you for that good question, John, I'm gonna let you start. You know, I think, Pete, we're, we're comfortable with the enrichment that we're getting from using our PEM markers right now, but obviously we, you know, we haven't looked at all the data yet, right? We need to look at the AHV data for the other half of the patients that have come in. I think we feel pretty confident, based on, you know, the analysis that we originally did and as well as how things are rolling out now. Okay, and, and, you know, as you, as you think about a phase III design, you know, I understand that, you know, you need to, you know, end the phase II meeting and to come to an agreement, you know, with the, with the agency. However, are there any modifications, you might make to enrollment or trial design, for, for a pivotal study, based on the accumulating data from 210 and 212? John, why don't you start with that question? No, you know, I think the, you know, the phase III design and, and basic kind of including characteristics are, are pretty common across all the, the, the three long-acting products that have been successful and, you know, are, are, are pretty much how we would go forward. Obviously, our patient population has to be PEM positive. That's a, a distinction. Other, you know, other than that, I think, you know, the, the timeline and the approximate ends, I think, are pretty, pretty close to what we would expect after we do the analysis at the end of the study. We don't, we don't see any radical departures from, you know, from those that have gone before us here. Okay. Thanks. Sorry, go ahead. Do you have, something to add? No, go ahead. Please, go ahead. Last question, you know, directed towards Duke, but, you know, Rick, John, more than welcome. You know, you've presented, you know, Lumos presented a number of times at different endocrinology meetings, you know, most recently at Endo 2023. Just wondering, you know, when you speak to KOLs, you know, some of your former colleagues, and even practicing, you know, clinicians about LUM-201, it's a mechanism, mechanism of action and how it may be differentiated from standard of care. You know, just curious to hear, you know, what the reception of this candidate and approach is and the data presented today. Yeah, Duke, why don't you go ahead? Yeah. Actually, it's very, very positive. As you may know, right, this is oral growth hormone secretagogue have been proposed for the treatment for years, but none of those trial have been, you know, successful. Here is the LUM-201, which is mechanism action, and the drug itself is somewhat differentiated in itself from the oral growth hormone-secreting peptide or secretagogue out there, right? They have long-acting, you generate IGF-1 that's sustained. Based on the presentation at PES and at Endo, one, we present only 210 data alone in regards to growth velocity, and it's very clearly shown that compared to historical data, moderate idiopathic population, the growth velocity is somewhat matched. We look at the combined data, trying to see that, you know, what the response look like. It seem like, you know, the dose that have been selected, especially 1.6 and 3.2, it's pretty comparable, and you can see those data in 6 month and 12 month, you know, result. Again, it's very small number, but most of physician really feel intrigued about the data. They did not know that this growth hormone, oral secretagogue, will work as good, right? Again, because it was failed in the past. Not to mention that if this drug get approved, will be alternative for their patient, and especially the impact of compliance should be less. Again, we expect that, you know, the burden injection with the majority of those patients suffering from daily along acting could be somewhat overcome by this new therapy. Again, overall, it's very, very positive. They all just need to looking forward for the top-line data and especially the new phase III pivotal trial in the future. The only thing I would add to that, Pete, is that, you know, when we, when we do these presentations at, at IMPE and March and PES and at Endo, the room's packed, right? There are lots of good questions, lots of excitement, lots of people, you know, wanting to talk to the presenters about this product. You know, one-on-one and then in the lecture halls, we, we feel a lot of excitement and a lot of interest. Yeah. Yeah, I, I, I might add, Pete, that, that, you know, we always have a booth at each one of these meetings, right alongside of all the competitors in the growth hormone space. I am absolutely amazed at the level of interest and the, the, the number of really great questions and just overall excitement that everybody feels over the fact that, that there's a possibility of an oral alternative for their patients. I mean, it's a very important and exciting space to be in right now, just based on the feedback from these clinicians. That's great to hear. Thank you for taking our questions, and congratulations on the progress. All right. Thank you, Pete. Thank you. I'm showing no further questions on the line. This concludes the Lumos Pharma Q2 Earnings Call. Thank you, and have a great day.