Good afternoon, Welcome to Lumos Pharma's Q1 2023 financial results conference call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will then 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 investor's 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, and David B. Karpf, our Chief Medical Officer, will join for the question and answer section. I will now turn the call over to Rick. Thank you, Lisa. Good afternoon, everyone. After the market closed today, we issued a press release announcing our first quarter 2023 financial results and provided 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 some of the highlights from the quarter in recent weeks before turning it over to Lori Lawley for a review of our financial results, and John McKew and David Karpf will join us to answer your questions. Let's begin. As we reported this afternoon, during our first quarter of 2023, we made significant progress in advancing our oral therapeutic candidate, LUM-201, in idiopathic pediatric growth hormone deficiency, led by the completion of patient enrollment in both our phase II OraGrowtH210 and OraGrowtH212 trials. 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 the PK/PD OraGrowtH212 trial in the fourth quarter of 2023. Importantly, as predicted, baseline characteristics for OraGrowtH210 subjects converged across the 1.6 mg/kg LUM-201 in the growth hormone cohort, cohorts between the interim data we announced in November and full enrollment. You may recall that the control arm for the interim analysis included outliers with greater growth than prior data precedents. With the conversions of age and other key predictive baseline characteristics across these two cohorts at full enrollment, we now have better balance in baseline characteristics and therefore believe we should see more similar growth rates between these two arms at final analysis. During the quarter, we were pleased to see an updated interim data from our trials presented at the 2023 International Meeting of Pediatric Endocrinology, or MPE, that was held in Buenos Aires, Argentina in March. The presented data demonstrate that LUM-201 possesses both a natural endogenous mechanism of action with potency to stimulate meaningful growth in a moderate idiopathic PGHD patient population, as well as a favorable safety profile. This included an oral presentation of OraGrowtH212 data by Dr. Fernando Cassorla that further supported the pulsatile mechanism of action of LUM-201 and highlighted growth stimulated with LUM-201 in PEM-positive idiopathic PGHD subjects and a poster presentation by Dr. Alison Lunsford demonstrating that the 1.6 mg/kg LUM-201 dose produced 8.6 cm a year annualized height velocity, again, in line with historical growth for moderate idiopathic PGHD patients treated with injectable standard of care growth hormone. Data demonstrated that LUM-201 possesses a favorable safety and tolerability profile. The presented data further reinforce our prediction from the interim analysis we announced last November that the 1.6 mg/kg LUM-201 dose is on track to meet growth expectations based on historical database averages. Importantly, we believe the IMPE medical meeting was critical for raising awareness and understanding of LUM-201 among key opinion leaders in global pediatric endocrin community. Among the pediatric endocrinologists in attendance at IMPE, the interest in LUM-201 and its potential as an oral therapeutic to treat PGHD was significant. There are those present who are familiar with Merck's original evaluation of LUM-201 in an all-comers PGHD trial and the lack of success there. Yet that trial, I should say, enrolled both severe PGHD patients unable to secrete growth hormone, as well as more moderate or idiopathic PGHD subjects. Once this audience was shown Lumos Pharma's data demonstrating that moderate idiopathic PGHD patients selected by our PEM strategy grew in line with historical averages. There was an acknowledgment that LUM-201 had the potential to become the first oral therapeutic to address this patient population treated solely by injectable therapies for the last four years. We are pleased that interim data from our both OraGrowtH trials were also accepted for presentation at the upcoming Pediatric Endocrinology Society meeting later this week, including an oral presentation on OraGrowtH210 trial interim data given by Dr. Andrew Dauber, Chief of Endocrinology at Children's National Hospital, and a poster presentation on OraGrowtH212 trial interim data by Dr. Fernando Cassorla and presented by our own Dr. David Karpf. We believe that presentations at IMPE and PES and other medical meetings will continue to increase awareness of LUM-201 among the Pediatric Endocrinologist community and garner even greater excitement for the potential for an oral therapeutic candidate in pediatric growth hormone deficiency. Turning to other developments now. We continue to support our clinical collaboration with Dr. Laura Dichtel in Massachusetts General Hospital to explore the potential of LUM-201 in nonalcoholic fatty liver disease, or NAFLD. This investigator-initiated pilot study was supported by data presented by Dr. Dichtel at the ENDO 2022 Conference. At that medical meeting, Dr. Dichtel reviewed positive data evaluating injectable growth hormone in NAFLD, which supported the assessment of oral LUM-201 in the same indication. As NAFLD is a chronic condition prevalent in approximately 25% of adults worldwide, a daily oral therapeutic, such as LUM-201, could provide a welcome alternative to a lifetime of daily injections of growth hormone in this indication. Enrollment in this pilot study of LUM-201 in NAFLD is continuing. As we mentioned on our last earnings call, Lumos Pharma filed a novel formulation patent for LUM-201 last year, which could extend IP protection to 2042. Currently, LUM-201 has patent protection through 2036 for the detection and treatment of growth hormone deficiency, as well as orphan drug designation, which offers extended protection of up to 7.5 and 12 years from the date of drug approval in the U.S. and Europe, respectively. We expect to hear from the U.S. Patent Office later this year. As previously mentioned, we believe that LUM-201 has the potential to address up to 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 geographic regions. As we mentioned on our last earnings call, we have narrowed our focus to idiopathic short stature or ISS and Prader-Willi syndrome, where we see a sizable opportunity both in the U.S. 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 gonna turn it over to Lori for a review of our financial results. Thank you, Rick. Lumos Pharma ended the quarter on March 31st, 2023, with cash equivalents and short-term investments totaling $58 million, compared to $67.4 million on December 31st, 2022. We reiterate our expectation for average cash use of approximately $9.5 million-$10.5 million per quarter through 2023. Cash, cash equivalents, and short-term investments as of March 31st, 2023, are expected to support operations into the third quarter of 2024, well beyond our announcement of top-line phase II trial results in the fourth quarter of 2023. Research and development expenses were $4.4 million for the quarter ended March 31st, 2023, an increase of approximately $0.1 million compared to the prior year period. The increase was primarily due to an increase of $0.5 million in clinical trial expense and $0.1 million in legal and consulting expenses, offset by a decrease of $0.5 million in contract manufacturing expenses. General and administrative expenses for the quarter were $4.4 million, an increase of approximately $0.7 million compared to the prior year period. The increase was primarily due to increases of $0.4 million in licensing expenses, $0.2 million in personnel-related expenses, and $0.2 million in travel expenses. The net loss for the quarter ended March 31st, 2023, was $7.3 million, compared to a net loss of $7.7 million for the same period in 2022. We ended Q1 2023 with 8,183,296 shares outstanding. With that, I will turn the call back to Rick to conclude for us. Thank you, Lori. To recap, our phase II clinical trials for LUM-201 are now fully enrolled. We're in a position to report top-line data from both studies in the fourth quarter of 2023. Additionally, between our interim data announcement last November and full enrollment, age and other baseline characteristics for OraGrowtH210 subjects converged across 1.6 mg/kg LUM-201 and growth hormone cohorts, as predicted, given the stratification of the trial by age and the balancing effect of the additional subjects included at full enrollment. Our confidence in these trials is reinforced by additional data presented at IMPE in March. Our data to be presented at PES later this week. We believe the presented data further demonstrate that LUM-201 possesses both a favorable safety profile and a natural endogenous mechanism of action with potency to stimulate meaningful growth in this idiopathic PGHD patient population. We continue to support the exploration of LUM-201 for the treatment of NAFLD through a pilot investigator-initiated trial. We have narrowed our focus for future indications for LUM-201 to two compelling opportunities in attractive markets. In addition, by prioritizing our PGHD program and being conservative with our cash usage, we expect our current capital to support operations into the third quarter of 2024. We also submitted a patent application for LUM-201, which, if approved, will extend IP protection for the commercialized version of LUM-201 through November of 2042. 2023 is off to a good start for Lumos Pharma. We believe we're poised to demonstrate that LUM-201 has the potential to disrupt the worldwide growth hormone market that's been dominat ed for almost 40 years by injectable products. We're excited to continue to advance our programs and look forward to disclosing top-line data in the fourth quarter of 2023. Thank you very much. Operator, we're ready to take questions. Thank you. At this time, we will conduct the question-and-answer session. As a reminder, to ask a question, you will need to 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 comes from the line of Catherine Novack of Jones Research. Your line is now open. Hi, good afternoon. Congrats on the quarter, thanks so much for taking my questions. I'm just curious, as you're attending these medical meetings, speaking with KOLs, how significant are six-month AHV data for KOLs in this space? You know, we know that the important endpoint is going to be 12 months, that's when you also start to see the attenuation of injectable growth hormone AHV. How important is it going to be to show 12-month data in this phase IIb as well? Can you give us a sense of, you know, how much follow-up you'll have for some patients beyond the initial six months? Yep. Thanks for the question, Catherine. I'm gonna let our Chief Medical Officer, David Karp, begin to answer that question. I think that John McKew may have something to add. Go ahead, David. Sure. Thank you very much for the question. It's important to point out that the phase II studies for all of the last ones are six months in duration. six-month AHV is to some extent predictive of 12-month AHV. As you point out, the 12-month, 12 months is the endpoint in the pivotal phase III trials. We were very encouraged that the 12-month data looked actually even better for us than the six-month data did in the interim analysis. Let's see. We are committed, as you know, we have fully enrolled all 82 subjects. Well, 8 subjects in the two-10 trial, 11 subjects in each group in the two-12 trial, and we'll have the six-month height velocity on all of those subjects in the, in the fourth Q presentation. We also showed some nine month and 12-month data. In this kind of the data, we'll have even a greater sample size at nine month, 12 month, and in later time points as well. We should have a reasonable amount of 12-month data, in the fourth quarter to present. John, do you wanna add anything? No, I mean, I think I'll just stress a little bit, Catherine, that we'll have data beyond 12 months as well, so the durability of effect can be there, and we can really. Mm-hmm. what the, you know, the slope is of an individual patient's growth is. Got it. Then I'm wondering if you can give me a sense of next steps, you know, potential next steps following the phase IIb readout. Can we anticipate initiation of registration and directed phase III program? How confident are you in taking this 1.6 mg/kg dose forward into pivotal studies? Are there any modifications you might make to enrollment or trial design for a pivotal study? Thanks, Catherine. I can tell you know, we are fully committed to the whole team in doing everything it's gonna take to start this phase III study as quickly as possible, including the recruitment of the study sites around the world. First, we know who the high responders have been in the phase II study. In addition to that, we're adding some other territories around the world that have been traditionally high enrollers in countries like China. Extremely high enrollers, in fact. Also I think we're pretty confident going forward given the fact that when all the long-acting growth hormone studies were being conducted, especially the later stage, there was a great deal of competition between three separate companies who were competing for the same patient population. I think we have a sort of a clean slate, and we don't have this as much of a, let's say that the competition has been diminished. There's no one else as far as we know, doing trials in PGHD out there at this time or by the time we start our phase III. John, do you wanna add in terms of the other part of that question? Sure. I heard three questions, Catherine, I'll start with the first one, which is kind of timing of moving from phase II. We are incredibly methodical in how we're approaching this and thinking through, you know, this large data package that we're gonna get. Obviously, we'll analyze it quickly and get it out in top-line form to investors and the public. We'll also dig very deeply into this data and prepare our request for an end of phase II meeting with the FDA, right? That'll be a very important step towards moving to our pivotal. We'll negotiate kind of the outlines of the phase III trial, the non-inferiority margin, all the pieces that are gonna be required for us to move forward. We'll also have a discussion with the FDA about our, you know, phase III commercial products. I think that'll be a very important next step. As Rick said, you know, we'll be working very, very closely with our CRO to do as much upfront work as we can in the US and globally, right? When we get both the U.S. and ex-U.S. regulatory authorities okay, that we'll be ready to really quickly move into enrolling subjects. You also asked about the 1.6 being the dose to move forward, and I think that's, you know, right now, that's what we feel comfortable with after the interim analysis. Obviously, we're gonna wait until we have the full data set of Q4 to make a final decision there. The data right now points to 1.6 as being optimal. The third part of your question was about patient selection in phase III, and I think the way I would answer that is that we've learned an enormous amount about the kind of patients who respond to our LUM-201 from our phase II study, right? We've not only, you know, figured out what those patients are like, we've applied, you know, this ten strategy to those subjects to really isolate them prospectively and bring them into the trial. We understand, you know, in terms of enrollment, we found a number of KOLs who are really good at finding these patients among their treated population. I think we have a lot of knowledge to apply to the phase III kind of final designs to help us very quickly isolate the right population and move forward. Yeah. I think I've checked off all three of the questions. You, you know, Catherine. You did. I might add, you know, with meetings like MPA, and other connections with the investigator community, I think there's a... As we share the results with these investigators and KOLs, I think there's almost a palpable excitement in the community because this is the first time that they've been able to work with an oral therapeutic in this space. I think that that bodes well for us in getting enrollment going and going well for this phase III trial. Rick, could I add a little bit? Sure, sure. Go ahead, David. Okay. You also seemed to ask about the design of the phase III. There, what I'd like to say that the key factors really for a successful phase III is having a good homogeneity of the patient population and having good balance between the groups. I'd like to point out that you can see the impact of heterogeneity if you look at the phase III Ascendis heiGHt Trial versus the phase III [REAL4-Segrea] trial. Both of those trials are inherently more heterogeneous than our trials because they enroll the full spectrum of disease, severe organic to moderate, less severe idiopathic. The REAL4Segra trial had a higher percentage of severe patients than did the heiGHt Trial. As a result, the growth hormone response in the control group of that trial was 11.7 cm per year in 12 months. In contrast, in the heiGHt Trial with, you know, severe but not as many as the REAL, the response was 10.3 cm, 1.4 cm lower. Because our phase III will be a much more homogeneous trial because we're only selecting the less severe idiopathic who are further up, also PEM chosen, it'll be inherently more homogeneous than either of those two trials. Because it's less severe, we would expect to see a high velocity similar to that in the idiopathic population in the heiGHt Trial, which is concordant with the databases, around 8.3 cm-8.6 cm per year. There are three factors which will predict the phase III trial will be even more homogeneous, certainly than our phase II trial. Most importantly, have much better balance, importantly, than the phase II trial. As far as balance, the phase III will be much, much larger than phase II. The phase III will be one dose of LUM-201 in 120-140 subjects versus 60-70 subjects on growth hormone. The much larger trial inherently will get much more, much better balance than either our 10 subject per group interim analysis or even the 20 subjects we're reporting in fourth quarter. The greater size of the trial also allows us to stratify by three factors instead of two factors, which will also improve the balance. What really speaks to the homogeneity is that based upon our learnings from phase II, we're actually adding two inclusion criteria, which will make it concordant, very similar to that in the heiGHt Trial, which should further improve the homogeneity of the trial. Does that answer your question about the phase redesign? That does answer the question. Thanks so much for taking the questions. Looking forward to data coming up at the end of this year. Thank you very much. Thank you, Catherine. One moment for our next question. Our next question comes from Charles Duncan of Cantor Fitzgerald. Your line is now open. Yeah, good afternoon, Rick and team. Thanks for taking our question and congrats on progress in the quarter. I had a couple of questions. First about the IMPE meeting. Well, as you characterized it, was enthusiasm was palpable. I guess I'm wondering when you, when you talk to, you know, KOLs about the severe versus moderate patient population, I guess I'm wondering if that is a paradigm that is going to prove to be a challenge in the commercial setting, or do you think that the use of the PEM system is really going to help out there? In terms of the implications for the phase III program, could we almost assume that the PEM and I guess the enthusiasm or confidence that a patient may respond is going to enhance enrollment rates, perhaps over the past experience in this field? Yep. Thanks for the question, Charles. John, I'm gonna let you start with it, with your answer. Sure. Thanks, Charles. We appreciate the question. I think, you know, we had as Rick mentioned, a presentation and a poster at IMPE and a booth as well. We got lots of interactions with, I think, some of the key European, South American and U.S. pediatric endocrinologists. You know, they really got an understanding of the, you know, a broad understanding of the mechanism of action of our molecule and how it is different than growth hormone. I think that connection with the type of patient population that is going to be treated is very clear to most of the ped endos that we chat with. They really do see the impact this molecule could have in that population, right? The more moderate PGHD population. I'll just, you know, mention broadly in this population that, you know, there are kids who are needle phobic, the kids who are probably most needle phobic tend to be in that moderate PGHD population, right? The kids who are really severely growth hormone deficient are gonna take the shots or take the treatment however it comes. I think that there is an opportunity there for this group of kids who is more moderate and may be a little needle averse. I think clinicians really like the opportunity to be able to offer them something that's oral. I think there's a good understanding as we start to present more and more of this clinical data that we've been releasing, among the pediatric endocrinology community about the advantages that this molecule offers to the moderate population. Very good. That's helpful. David, anything to add there? I'll just add that, even in the current time, pediatric endocrinologists are dividing their population into idiopathic versus severe organic. They're really seeing a lot more idiopathic than severe. You know, right now they just can offer them one therapy. I think that this will play into the enrollment in our trial because they're already making the, you know, the separation between the organic and the idiopathic population in their current kids. I think also that the... just having idiopathic GHD is pretty predictive for response to LUM-201, and that's really augmented by also being PEM positive. I will also point out that the PEM test based upon the phase II data will be much simpler in phase III and at launch, with simply the single dose of LUM-201 and a single blood test an hour later, which I think will be very acceptable, 'cause it's far less burdensome than the two stim tests these kids undergo with all of our pediatric endocrinologists. Helpful, John and David, appreciate that added color. Had a question about the commercial form. I'm not sure if I misheard this, but do you have a commercial form to be able to move into phase III? Is that something you're still developing? Would you start a phase III without a commercial form if it is the case that you're still developing? No. Good question, Charles, I'm gonna let John answer that. Yeah. I mean, obviously we wanna interact with the FDA and get agreement with them about how we're gonna move forward with a commercial product. The best possible way to do that is to, you know, to fully explore that product in phase III. You know, I think we've talked about the patent we recently submitted, which is tied into formulation and aspects of the molecule that lend new opportunities in formulation. I think we, you know, we're gonna move down that path with agreement with the FDA about the best way to, you know, to utilize the molecule and make this a really easy molecule to administer. you know, our plan is to move forward and get agreement with the FDA, as I mentioned, as we move towards a phase III study. To answer your question further, Charles, of course, that product will be used in our phase III trial. Oh, okay. That clarifies it. Last question is more strategic. John, well, or Rick, excuse me. We've talked in the past about potential for other geographies in which PGHD is really a big issue. I think you alluded to China earlier this call. I guess I'm wondering, do you think that the data that you could present in the fourth quarter could even further enhance opportunities to pursue development either with a collaborator or not in other geographies? Yeah, I don't think there's any question that, you know, when a company gets at this stage in the development of their product, there's typically what happens is a number of players show up. As you know, in this is a mature space. There are major players, and there's no question that we'll be fully engaged. Choosing the right partners at the right time, the right territories is a nice problem to have. Our business development is led by, you know, almost a 30-year veteran Aaron Schuchart. Aaron is a busy man these days, let's put it that way. Okay. Thanks for taking my questions. Thank you, Charles. One moment for the next question. Our next question comes from Leland Gershell of Oppenheimer. Your line is now open. Thanks for the update and for taking my questions. Rick, wanted to know, in addition to the baseline characteristics update for the 1.6 milligrams, I know that's the dose of focus for forward study. Wondering if you may give us the opportunity to hear on what may be a narrowing of the baseline differences in the other two doses that you are looking at in the study. Thanks. Yeah, I'm, John, I'm gonna let you answer that question, but thanks for the question, Leland. Yeah. We, we just focused on 1.6 and growth hormone because those are kind of the two most important cohort doses, or the two important cohorts to compare based on our interim analysis. We obviously have baseline data. I think the trends are similar across all the cohorts. There's a little moving around here and there among the different cohorts, but, they all are moving generally in the same direction. Okay. Thank you. Also want to ask with respect to starting the phase III. This may have been asked earlier, but with respect to the new oral formulation, assuming that the USPTO grants those claims, would it simply be a matter of a bridging study, bioequivalence type study to get into the phase III, or any other clinical work that you have to do? Thanks. Yeah. Go ahead, John. Yeah, that's I mean, in general, when you introduce new, you know, a new formulation, you have to do a bridging study, right, to compare back to the data that you have in phase II. That is correct. Presumably that could be done inside of 2024. How should we think about the timing of that with respect to then, you know, starting the next, you know, the pivotal study? John? Yeah, I mean, we're obviously keen to keep that up as soon as possible, right? As soon as we can, because I think it is, it would be key to moving forward. Yes, it's, it is definitely on our to-do list. Yeah. As much, any work that we can do, Leland, on a parallel basis, without too much risk, we're going to do. We wanna start this phase III study as quickly as we possibly can. Right. Okay. Rick, it sounds like you may be generating those data in parallel with completing the 210 and 212 studies, or at least starting to, and then you could be a bit accelerated as we get into starting the phase III. Yeah. There's a lot of work to be done between the completion of the trial, the reporting of the data, everything that needs to be done leading up to the end of phase II meeting with the FDA. Yeah, so in that time period, obviously, there's a lot of parallel work that's gonna be done. Got it. Very good. Okay, thanks very much for taking our questions. Um. One moment for our next question. Our next question comes from Ed White of H.C. Wainwright. Your line is now open. Good afternoon. Thanks for taking my questions. Actually, I just have one. You had mentioned that you'd narrowed the indication targets to ISS and PWS. I'm just wondering how to think of, the timing to the start of the next indication. Do you think that it's possible to decide which target you will go after this year and then initiate the study for the new indication next year? You know, can you run that study alongside of the phase III that you're planning? Yeah. Yep. Good question, Ed. Obviously, as a company at this stage in development and the market conditions as they are, we're really fortunate to have the cash runway that we have in terms of getting the readout of these studies. We're gonna focus all of our resources on the PGHD indication obviously. As the market evolves and we're able to access more capital, we'll make those decisions along the way. Obviously, we spend a lot of time with the KOL community and ISS and PWS, know that they're, they'd be excellent directions for us to take. We'll try to start those studies as quickly as we're able to given any kind of financial restrictions we may or may not have. Okay, great. Thanks, Rick. One moment for the next question. Our next question comes from Yasmeen Rahimi of Piper Sandler. Your line is now open. Hi, team. Thank you so much for taking my questions. Two for you. maybe, if you could just allude to what the cost of the phase III would be based on, some of the analysis that you have run, so you could provide some color there. Also maybe some color around, you know, when you do the math in terms of like enrollment timeline and 12 week, 52-week treatment duration, like assuming you start your phase III in early 2024, like how soon could you be able to bring it to the finish line? If you could just provide some timing around that would be helpful. Then the third component of my question is, you know, like, what are the various data scenarios that you are expecting to see and what action would you take as we're headed into the top line data from 210 and 211? I'll jump back into the queue. Thank you. Okay. Thanks, Yas. Good to hear from you. Appreciate the question. you know, I think there's a great deal of precedence in terms of how long it's taken most companies to enter about, you know, you know, a study of about this size. I wanted to go back to, I think, my discussion a little bit earlier, and the fact is that there was a great deal of competition between three companies, you know, concurrently conducting three large phase III studies globally. That doesn't exist for us. That's one positive thing. Also what John said earlier, and the fact is that we, I think we've taught the KOL community quite well in terms of the type of patient we'd be looking for in this clinical trial, in addition to the fact that, you know, obviously, de-risking all the trials by using our PEM strategy. In terms of time to enroll, I think once again, I think the Ascendis trial, the phase III, took about 18 months. I think the trial was perhaps a little bit larger than we're thinking of, or, you know, roughly, so. As I said, we don't have the restraints of a great deal of competition from a number of areas. In addition, by adding, you know, a geographic area like China that has, you know, super enrollers, I think we're gonna do everything we can to even, you know, beat that strategy. Of course, all patients will be treated for a year. In terms of the data scenarios and what they're expecting to see, John, would you comment, please? Sure. Maybe I'll just comment a little bit first on the timing. You know, Yas, I think I'll just reiterate that when our data package does read out in Q4 of this year, we have to put together a package and request a meeting for end of phase II with the agency. From there, you know, we have to agree on our phase III protocol, the non-inferiority margin. After that meeting, we submit the protocol, then we get the okay from the FDA. We also have to reach out to all of the other regulatory agencies, ex-U.S., get their buy-in, then we can officially start the phase III. We'll do as much upfront work as we can as we talk about in terms of lining sites up, getting everything ready as quickly as we can while we wait for all those regulatory approvals. I just wanted to chat through the timeline of starting phase III. What was the other piece you wanted me to comment on, Rick? I'm sorry. The last one was the cost of the phase III, and I'm gonna let Lori jump in and answer that question. Sure. Yeah, I think at this point in time, we are not giving any guidance around the cost of the phase III. you know, we continue, as John mentioned, to refine and work on the planning, and there's still quite a bit to be done to be prepared for a phase III. At the point in time that we have those specifics of the costs available, we will definitely put out that guidance. Yeah. Yeah. Yas, I think that in spite of what the current market conditions are, I think there have been really good examples of several companies or multiple companies who have been successful in raising capital with positive results. That's heartening to us. I think there seem to be even more and more examples as time goes on. We hope that the market conditions also improve by the time we get this readout. Great. Thank you so much, team. Sure. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.