Good day, everyone, and thank you for joining the H.C. Wainwright 26th Annual Global Investment Conference. My name's Steve Bursey. I'm an equity research associate at H.C. Wainwright, and I'd like to welcome Rick Hawkins, CEO of Lumos Pharma. Now I'll turn it over to Rick. Thank you, Steve, and thank you, H.C. Wainwright, for this opportunity to speak to all of our shareholders and our stakeholders, and I'd like to give you a background as the fact that we are in the growth hormone market. Recombinant growth hormone has been approved for almost 40 years now, all injectable products, and Lumos Pharma is working with a once-a-day oral growth hormone secretagogue with a unique mechanism of action. Now, this is a mature market, as I said, it's about close to $5 billion for about 11 different indications and growth hormone deficiency. We're leading off with a indication of pediatric growth hormone deficiency, which is about a $1.5 billion global opportunity. Our market research tells us that as the first oral product in the space, we have a chance to really shift this market really dramatically with the first oral product, and actually expand the market. Our product is not growth hormone or an oral formulation of growth hormone, but it's a growth hormone secretagogue, a small molecule, that works in a very different way. Its mechanism of action has some clear-cut advantages because all we do is restore the natural physiology. We have orphan drug status in US and EU. We'll get it in other parts of the world as time goes on, and we have IP protection out to 2042 for the novel oral formulation. And we've de-risked our program dramatically by using what we call a PEM strategy or Predictive Enrichment Marker strategy, by being able to select the patients we believe the drug will work in, and we've actually established that fact in our phase II studies. But we can identify the responders and by giving a dose of our drug and taking a growth hormone, an IGF-1 level within an hour and determine whether that patient has moderate growth hormone deficiency or not. Now, we've reported on two phase II studies, and we've met all primary and secondary endpoints in both of those studies. We demonstrated a significant annualized height velocity from the beginning of... from baseline, I should say. And we also showed a consistent PK/PD profile, and a very robust safety profile of the drug, not just in studies that had been done prior to these PGHD studies, but in about 1,300 patient population in a drug that was in a prior life. So we had an end-of-phase II meeting with the FDA in the second quarter or the second half of last year. And we're gonna talk- I'm gonna talk quite a bit about our phase III program. Once again, considerably de-risked because we have a placebo-controlled study going forward. I'll go into the details of that in a second. We're gonna initiate that trial in the second half of 2025. Market-wise, global sales almost about $5 billion in 2022, and expected to grow to over $8 billion by 2030. I can say that long-acting growth hormone products that have been recently approved address some of the limitations of daily injectables and have expanded the market and expanded market awareness. With the first oral, we think that we are going to have a chance to be able to develop the market that much more as a result. If you go to the next slide. We had a global phase II program in about 50 sites. The primary study was in naive-to-treat PGHD patients, we called the OraGrowtH210 trial. It was a global trial, and then we had a single-site study and a PK/PD study in Santiago with a very experienced investigator there, where we really underscored the really different mechanism of action of our drug, and underscored some very nice data that shows that the pulsatile release of growth hormone really is meaningful for long-term growth. We also all patients are going on long-term treatment, and will, over time, be able to have three to four years of coverage and height velocity and safety in all these patients before we start our phase III study or after our phase III studies. Of course, we've engaged the growth hormone community in other indications, Prader-Willi, idiopathic short stature, and other indications to think about going to as other indications that growth hormone is currently approved for, but we also have a pilot study, an investigator-initiated study at MGH in non-alcoholic fatty liver disease. That study is ongoing. There have been some very positive results with daily injectable growth hormone in this disease that... and have been published, and we believe our once-a-day oral shows much gonna have much greater utility, and use in this eventually in this disease. If you go to the next slide. So our value proposition versus a recombinant growth hormone, other than the fact that obviously it's an oral versus an injectable, is primarily the fact that the mechanism of action of recombinant growth hormone is really, that's a synthetic growth hormone. You get a bolus effect and then tail off over those twenty-four hours, whereas all we do is restore the natural pulsatile release of growth hormone with our compound. And, you know, growth hormone is an exogenous effect, whereas our drug works and by normalizing growth hormone, IGF-1 levels in an endogenous fashion. And, in order to have the height velocity that you achieve with recombinant growth hormone, you have to give four to five times the normal amounts of growth hormone a patient makes, in order to achieve the growth. Whereas we, all we do is restore growth hormone and IGF-1 levels to normal, within a normal range. So those frequent excursions of IGF-1 with recombinant growth hormone don't happen, or they're exceedingly rare with our compound. So we believe with an oral product once a day, where our compliance is going to be considerably improved. And then, of course, as a small molecule, our cost of goods are gonna be much less, and our flexibility, no matter what the price is of growth hormone in the marketplace, is going to be greater. So to underscore how recombinant growth hormone works versus our compound is, you look at the graph to the left here, that solid blue line is daily injection of growth hormone, where you get a bolus dose, where you get a peak effect in a short period of time, within hours, and that trails off over a twenty-four-hour period of time. That's very different than the normal physiology, where we release growth hormone twenty-three, twenty-five times a day, as you can see by this, the normal graph of this patient. The graph on the right shows directly from data from a study, Dr. Cassorla's study, the PK/PD study I referenced earlier, where we took blood draws every 10 minutes over a 24-hour period. And you can see there's the baseline release of growth hormone in a PGHD patient, and then six months later, the same frequent blood draws, and you can see that all we do is increase the amplitude of each one of those pulsatile releases. We normalize growth hormone and IGF-1 levels, and so this very different mechanism of action is important because there are very few excursions beyond normal ranges of IGF-1, unlike recombinant growth hormone. So underscore our compound, our mechanism of action is very different. As I said, instead of the exogenous effect of growth hormone, our drug stimulates the growth hormone secretagogue receptor 1a in the anterior pituitary. It stimulates us to increase the production of growth hormone, further mediation through the liver to make a secondary growth factor, IGF-1, and those two growth factors together go to the long bones and cause growth. Now, there's the same receptors in the hypothalamus, and there's a... When we make enough growth hormone, there's a feedback loop through the hypothalamus, where we then sort of put the brakes on any further production of growth hormone, and that happens twenty-three, twenty-five times a day. So in other words, we restore the natural physiology with this compound. Go to the next slide. Furthermore, our phase II program and our phase III program is de-risked in the fact that we have developed a PEM strategy. In other words, we call predictive enrichment strategy, where we give a dose of our drug to a patient to qualify them for the study. We take a blood draw within an hour, and if they can make a certain amount of growth hormone and IGF-1, then we know that's a patient that likely our drug will work in, and that's roughly about two-thirds of the patient population versus a third of the patient population we call PEM negative. Those patients can typically can't make, store, or release growth hormones for various reasons, and they should be on recombinant growth hormone. Those are the more severe patients. Ours is the moderate patient population, which is most of the patients out there. In fact, we have accessed a number of large databases, the former Eli Lilly and Pfizer databases, the GeNeSIS and KIGS, and other databases, to show that our growth from our recent studies, our Grow 210 study, is comparable in producing annualized height velocities in this moderate patient population group. If you go to the next slide. Furthermore, if you compare this to baseline in our combined studies patient population, you'll see that the baseline, those patients grew about four and a half centimeters, and we increased that to six months, is eight point two centimeters, and to seven point six centimeters at up to a year. That baseline, if you don't treat those patients, these patients do not grow, so that four and a half centimeters is something to keep in mind as we go further in this presentation. If you go to the next slide... durability of response is really important. It's well known that from databases the drop-off from year one to year two drops off by about 20% in moderate patient population who take recombinant growth hormone. In our studies, our drop-off was only 10%, and I think that... There's a to date in the data we have so far that's also we believe is a not only shows the durability of action of the drug but I think long-term it's very exciting fact that underscores the fact that pulsatility restoring the natural physiology really is meaningful. If you go to the next slide. Now we know that also from accessing databases that what a normal healthy child makes in terms of the amount of growth hormone. In our studies we clearly showed that what we did was bring them within a normal range of growth hormone. And compared to recombinant growth hormone at standard doses, you need four to five times the amount of growth hormone to have a comparable growth. And so restoring this pulsatility over a twenty-four-hour PD effect really makes a difference in terms of growth. And you know, I think the agency clearly sees when they approve other hormones in this space, if you can restore to normal ranges, then many folks have ended up with an approved product, and that's what we're certainly hopeful for. If you go to the next slide. So there's some key milestones that along the way here that we believe we need to look at that are gonna show that we're gonna disrupt this injectable growth hormone market. First of all, we had positive end of phase II meeting with the FDA. It was a very supportive meeting. Essentially, the FDA suggested that we do a placebo-controlled study, and the reason for that is that they recognize that we are not growth hormone. We're a unique and novel growth hormone or growth promoter, we're a growth hormone secretagogue. They suggested then doing a registrational trial, a phase III trial, with placebo control. We're gonna initiate that in the second half of 2025, and I'll go into the details of that design, but we believe that this has tremendously de-risked this entire program. This is gonna be a twelve-month study, about 150 patients, same patient population, moderate growth hormone deficient patients. It's gonna be randomized two to one, and we're gonna have a crossover design. Now, 100 patients are gonna be on 1.6 mgs per kg a day for a year. But we'll have in one portion of the study, we'll have co-primary endpoints, and I'll go into the details of that in a second. But it's really important to note that to recruit these patients, everybody's gonna get access to long-term treatment for over three years. If you go to the next slide. Well, let's back up a little bit and talk a little bit more about this study, if you will, the last slide. Yes, the... Recall that those patients who weren't treated in our phase II studies grew about four and a half centimeters a year, and you can see that all of our patients grew substantially beyond that. And one of the endpoints we believe is gonna be growth annualized height velocity on the lower bound of the 95% confidence interval above 6.6 centimeters that the FDA certainly you know approved it for our phase II studies. We believe that's going to hold true for the phase III study that we're about to start. And so this program has been substantially de-risked as a result. If you go to the next slide. So what do we believe that's gonna happen in the marketplace? In a market that has been well established, once again, almost forty years. You know, daily injections of growth hormone or injections in general, in particular in children, there's always a compliance problem. And with daily injection, there's, you know, about 50%, 50%-60% compliance rate. And so in this space, if you miss three or more doses a week, you get really negligible effect. And I think that our market research clearly says that families and patients are gonna prefer to take an oral versus a weekly injection. And to achieve our targets, you know, once again, to remind you of the data, we had durable effects out to two years. We restore the natural physiology. We stay within normal ranges of growth hormone and IGF-1. We think that's important, by for one point, and I think that the agency, in terms of a regulatory review, is going to look at that favorably if we can continue to show that in our phase III studies. And I also believe that the marketplace is pretty clear. You know, the there's a great deal of jockeying with all the companies with growth hormone. You know, physicians don't like the fact that they're captive to the formulary, or whatever formulary position one company holds over another. We have a distinct product category, as an oral secretagogue. We believe we're gonna be a distinct product category, and in addition to that, we're gonna remind you our cost of goods are gonna be extremely competitive in terms of margins, with whatever the price of growth hormone is in the market. If you go to the next slide. The Lumos team is just the senior management I have listed here, but we have anywhere from 20 to 45 years of experience in drug development, and in particular, the rare disease space, we're not only a highly efficient and capable team, but we did these phase II studies during the height of the pandemic and so I think that our phase III program is going to be... We're gonna deliver on that, too. Let's put it that way. If you go to the next slide, the investment thesis here is that, you know, this is a very large market, almost $5 billion annually, and going to $8 billion soon. PGHD alone is at $1.5 billion and growing. Our market research certainly tells us that we have a chance to have a rapid conversion to oral, and a chance, because of its oral, to rapidly expand the market to other opportunities because it's oral. Now, underscore again, unique mechanism of action has it that restores the natural physiology, restores natural growth hormone IGF-1 levels, and underscores the fact that those excursions that happen, especially with long-acting growth hormone by IGF-1, beyond normal ranges, rarely ever happens with this compound. We have IP protection out to 2042 for this novel formulation, and orphan drug status also in the US and EU. We've de-risked our phase two program with our PEM strategy, as I described earlier, and we're gonna continue to use that to qualify our patients in phase three. And, you know, we clearly had met all of our primary and secondary endpoints in our phase II program, and we significantly increased annualized height velocity from the baseline in our patient population. And then once the safety profile is well-established, not just with the prior studies have been done, and in the life of this drug in about 1,300 patients, but then in a pediatric patient population we just studied. And I think we have a much clearer regulatory pathway and a program that is dramatically de-risked because of the placebo control, and a phase 3 program that will start the second half of 2025. So we believe that we are on the verge of a paradigm shift in the treatment of growth hormone deficiencies, and a first oral therapeutic in its class. Good. Go to the next slide. Okay. Well, thank you, Steve. Appreciate your time today. All right. Thank you, Rick, for taking the time to present, and thank you to everyone joining in to listen. Have a great day. Thank you.