Lumos Pharma, Inc.
Q4 2020 Earnings Call Transcript

Published: 10 Mar 2021

[Operator:]

Good afternoon, ladies and gentlemen, and welcome to the Lumos Pharma's Year-End 2020 Earnings Conference Call. At this time, 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, Director of Investor Relations. Ms. Miller, please go ahead.

[Lisa Miller:]

Thank you. 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.

[Rick Hawkins:]

Thank you, Lisa. And good afternoon and thank you for joining us on today's call. After the market closed, we issued a press release highlighting our recent clinical and corporate activity and providing update on our year-end 2020 financials. Last year marked a period of significant achievement for Lumos Pharma with the completion of our merger transaction, the monetization of our priority review voucher and the initiation in the fourth quarter of our Phase 2b OraGrowtH210 trial evaluating our novel therapeutic candidate, LUM-201, for pediatric growth hormone deficiency. Those events put Lumos Pharma on a solid foundation to pursue the development of orally administered LUM-201 with the potential to disrupt the PGHD therapeutic industry where the standard of care consists of daily injections of growth hormone. That momentum continues in 2021 as we move our clinical strategy forward. Our Phase 2b OraGrowtH210 trial continues to advance with data readout anticipated mid-2022. In addition, we expect to initiate our OraGrowtH212 trial shortly. This trial is a small single-site trial to illustrate the pharmacokinetic and pharmacodynamic effects of LUM-201 in PGHD and replicate the pulsatility data that currently exists for LUM-201 in adults. Also, today, we introduced our OraGrowtH211 trial, a long-term extension study for eligible PGHD patients who have completed our other LUM-201 trials. This extension trial will assess the long-term safety and efficacy of LUM-201 in children with growth hormone deficiency. We believe LUM-201 is essentially a pipeline in a product with the potential to target up to 11 other indications for which growth hormone has been approved.

[John McKew:]

Thank you, Rick. As Rick stated, we are excited to advance our OraGrowtH trials to validate LUM-201 in PGHD patients. We are also pleased about the recent peer-reviewed publications and upcoming ENDO presentation of data showing the novel mechanism of action of LUM-201 and the potential efficacy of LUM-201 in PGHD as compared to standard of care. Given its oral delivery and its mechanism of action that depends on the natural endocrine growth hormone axis, we believe that LUM-201 may offer a preferred treatment option for approximately 60% of children suffering from growth hormone deficiency. As a reminder, growth hormone deficiency can be defined by low to absent secretion of growth hormone from the pituitary gland. The current standard of care and other therapeutics in development for children with growth hormone deficiency consist of the delivery of a bolus of growth hormone or a long-acting derivative to restore growth. All of these therapies are administered by injection and act outside of the body's natural endocrine pathway feedback mechanisms. LUM-201, on the other hand, is not a growth hormone but is instead a growth hormone secretagogue that acts within the body's natural endocrine pathway. LUM-201 selectively acts on receptors in pituitary and hypothalamus to stimulate the body's ability to release growth hormone at the same intervals and subject to the same endocrine feedback loops that occur naturally. Utilizing this endogenous release mechanism should enable the naturally occurring IGF-1 feedback loop to be preserved if needed to help regulate the balance of growth hormone and IGF-1 levels in the body. Given the endogenous nature of LUM-201 activity as just described, individuals able to benefit from the molecule must have a functioning – a diminished pituitary axis. For this reason, Lumos Pharma is targeting the moderate PGHD population of patients who are able to naturally produce some growth hormone but in insufficient amounts to obtain normal adult height. Based on the analysis of prior clinical data, predictive enrichment markers or PEMs identified a moderate PGHD patient group likely to respond to LUM-201 therapy, which represents approximately 60% of the total PGHD population. These data demonstrate that specific PEMs of a baseline IGF-1 level of greater than 30 nanograms per mil and a peak growth hormone level of greater than or equal to 5 nanograms per mil after a single dose of LUM-201 identify this PGHD patient population likely to benefit from LUM-201 and illustrate why these are the PEMs we are using in our OraGrowtH210 trial.

[Gene Kennedy:]

Thanks, John. I will take some time now to review our Phase 2b OraGrowtH210 trial and provide a few more specifics on our PK/PD OraGrowtH212 trial to be initiated shortly. We initiated our Phase 2b OraGrowtH210 trial in PGHD last quarter, and the trial continues to advance. To review, this trial is a global multisite trial involving approximately 80 PGHD patients randomized into one of three dose levels of LUM-201 or a comparator arm of standard of care injectable growth hormone therapy.

[Carl Langren:]

Thank you, Gene. We ended 2020 with cash and equivalents of $98.7 million. This year-end cash balance does not include the final $26 million in proceeds from the sale of our PRV, which was received in January. For 2021, we anticipate average quarterly cash use of approximately $8 million to $9 million. We also expect that our reported cash balance plus the non-dilutive funds from the PRV sale will support our operations through the data readout of our OraGrowtH210 and OraGrowtH212 trials and contribute to supporting the expansion of the company's rare disease pipeline. We reported a net loss of $5.7 million for the year ended December 31, 2020, compared to a net loss of $9.7 million for the same period in 2019. Please refer to the press release we put out this afternoon for additional details on our financial results. Looking ahead, we hope to speak with many of you participating in the Oppenheimer, H.C. Wainwright & Roth investor conferences this month. We are also looking forward to speaking with all of you once we present our data at the ENDO annual meeting in late March. Now I would like to turn the call back over to Rick before we open up for questions. Rick?

[Rick Hawkins:]

Thank you, Carl. And so before I offer some closing remarks about our programs discussed above, I first want to say a few words about our outgoing Chief Medical Officer, Gene Kennedy. Gene joined Lumos Pharma management team here by way of our merger with NewLink Genetics, which was an oncology-focused company he joined in 2014 and where he also served as Chief Medical Officer. Gene helped us tremendously through the merger and Lumos Pharma's transition to a publicly listed company focused on rare diseases. While we would have loved for him to stay, he will now be returning to his roots in oncology as he joins a privately held company in that field. Gene, we want to thank you for your service to Lumos Pharma and wish you all the best in your next venture.

[Gene Kennedy:]

Thanks, Rick, for your kind words. I mean I really have to say that I've thoroughly enjoyed working with the entire Lumos team. As you said, I'm really returning to my roots. I am highly confident in the potential for LUM-201 and its ability to be efficacious in the PGHD population identified by the predictive enrichment markers and also in Lumos team's ability to execute on the clinical plan already in place. I hope to keep in touch with the team and will be watching from a distance and pulling for all of your success as the team advances the LUM-201 program in PGHD and expands beyond that purview.

[Rick Hawkins:]

Thanks, Gene. And well, as you can tell, we're excited to advance our OraGrowtH trials in PGHD and look forward to initiation of our PK/PD OraGrowtH212 trial. We're pleased about the data recently published and about our upcoming presentation at ENDO. And we are on solid financial footing to execute on our strategy and believe that our clinical trials will confirm the potential for LUM-201 to disrupt the PGHD market. We look forward to continuing to provide updates as we progress. And with that, we will open the call for questions. Operator?

[Operator:]

First question comes from the line of Charles Duncan from Cantor Fitzgerald. You are now live.

[Charles Duncan:]

Okay. Thank you, Rick and team. Thanks for taking our questions, and congrats on the progress on the 210 trial thus far. Actually, I had a question on that 210 trial. I imagine it's pretty early days in terms of enrollment. But can you talk at all about the pace of enrollment or the screen failure rate at this time? And would you anticipate the first patient to be through the six month period, the dosing period and therefore being able to start with the open-label extension trial, 211, by the end of the second quarter of this year.

[Rick Hawkins:]

Well, Chaz, that's a good question. We haven't really given any guidance yet on entry into the study. But suffice to say that we're progressing nicely. We haven't initiated all of our sites, but they're coming online in pretty quick order. And as Gene pointed out, there are some new sites with experienced investigators and KOLs in another part of the world that we believe will help us meet our goals of having a readout in 2022, year 2022.

[Charles Duncan:]

Okay. And anything about screen failure or that PEM strategy at all at this point?

[Rick Hawkins:]

I think it's too early in the game to really address that. I think the publications that John just went over gives us a great deal of confidence that the screen failure rate is probably going in parallel of what we found in that database. So I think that's – but as soon as we can, we'll report to you on that data.

[Charles Duncan:]

Okay. I appreciate that. And just one follow-up. John said a lot and said so quickly, and sorry if I missed this, but I think you mentioned that there might be, call it, a 60% or so patient population versus, say, previous estimates of around 50% that met that positive predictive enrichment marker kind of level that you're looking at. And I guess I'm wondering, could you go over that math again? And then in terms of, for example, what you would expect in terms of average height velocity for patients that are more moderate, could you compare and contrast what you would expect out of recombinant human growth hormone in the moderate patient population versus the more severely impacted patient population? What kind of numbers are you looking at over the course of an annualized height velocity?

[John McKew:]

Happy to answer that, Chaz. So we'll start with the numbers for the estimate of the patient population that could be responsive. So essentially, we've taken our PEM cutoffs and translated them so that we can use them in the GeNeSIS database and use the standard stim test diagnosis to help us sort patients into the same two groups, kind of the PEM-positive group and everybody else that are more severe. And so when you look at the large data set that's GeNeSIS, the kids we're focusing on are officially termed idiopathic growth hormone deficient children. And that makes up 73% of the children in the GeNeSIS database with the growth hormone deficiency diagnosis. Of those 73%, 84% meet our criteria of PEM positive. So multiplying 0.73 by 0.84 gets you to about 60% that could be responsive to our molecule and would fit into this PEM-positive category. We feel much more confident about this number just because it's derived from a very large Phase 4 data set. And I think it really is more of a real-world number than the estimate we could make from the 020 trial just because of the several regions that the trial was running. So we're confident about that number. The second question is about the height velocity that we see. So in the GeNeSIS data set, the group that is selected with our PEM cutoffs showed 12-month growth rates on recombinant human growth hormone of about 8.3 centimeters per year. And it's very clear that if you include a broader group in an analysis of potential growth, that includes many more severe patients that we would filter out from our trial, that population would have much higher growth. And that's simply because the kids who are more severe grow at a faster rate in those first six months. So that 8.3 centimeters per year for the same population that we're going to isolate in our trial is a pretty good indication of what 12-month growth data would look like in a trial that we're going to have going forward.

[Charles Duncan:]

But you wouldn't want to compare apples-to-oranges with this more severe patient pop or sample size or sample?

[John McKew:]

Yes. I think the more severe kids are going to grow significantly more, right? Depends exactly how you define more severe kids. But essentially, they're going to grow statistically different than the moderate kids. In our GeNeSIS analysis, it was 9.6 centimeters per year. So they're different and very different populations.

[Charles Duncan:]

Okay. And last question. Do you believe that prescribers will understand this or reimbursement authorities in terms of a response rate or annualized height velocity? Does that have any implications in terms of the conduct of the study and keeping patients on for the entire six months? Or do you think that's not going to be an issue?

[John McKew:]

So I think that most of the prescribing clinicians understand that the most severely growth hormone deficient kids grow the most in those first six months. And once they understand that the tools that we're using to select our patients are going to select for moderate growth hormone deficiency, I think they will understand the – they will have expectations set for how much the kids will grow. And it's not just that they're going to grow less on our molecule. They're going to grow less whether they're given recombinant human growth hormone or a different molecule, right?

[Charles Duncan:]

It makes sense. Thanks for taking my questions.

[Operator:]

Next one on the queue is Ed White from H.C. Wainwright. You are now live.

[Ed White:]

So just to be clear on enrollment for the sites, I think you previously had said you're expecting to enroll patients at 40 sites in the U.S., Poland, Australia and New Zealand. And now you will have interest in these other areas, the Ukraine and Russia and Israel. Can you give us any idea of the number of sites that are currently enrolling patients? Or what we would expect to see, say, by the end of the year? Should they all be up and running by then?

[Rick Hawkins:]

Yes. Gene, do you want to take that?

[Gene Kennedy:]

Yes, certainly. By the end of the year, definitely. Well, I think we expected them to be up before the end of the year. But no, we have – many of our U.S. sites are up and running. The few that aren't will be coming up in the next weeks to month and then the international sites, again, right – slightly shortly thereafter. So we're – and these aren't – we're announcing our intentions to open sites in these countries today. It's not that we are starting the work today if you understand what I'm saying. This has been – we've been preparing this for a while. So we expect these sites to all be able to contribute pretty soon.

[Ed White:]

Okay. Thank you. And then on the OraGrowtH212 study that was affected by the fire, how long will you give the site to open or before you start thinking about moving that study to a different location?

[Rick Hawkins:]

Gene?

[Gene Kennedy:]

Yes, certainly. I mean we – thinking, we're already obviously exploring options. But the report we have is that they're likely to be back up and running very soon. I mean it's a major pediatric hospital. It serves a large portion of the population of Santiago, Chile. And they're optimistic they'll be finished with their repairs in other parts of the building, but it's had some consequences in the part where the clinics are. So I think we're all optimistic that this is going to be a short delay. If it proceeds beyond our guidance into Q2, then obviously, we'll have to consider other options.

[Rick Hawkins:]

And Ed, I think the sound business procedure here is to – no matter what, even though we're confident that this site is going to be a viable site going forward, we want to hedge our bets and make sure that we have a backup plan. That's what it's all about.

[Ed White:]

Okay, thank you. And then my last question is just on the extension study, 211. Once those patients are enrolled, how long do you expect them to continue to be following? I mean are these patients eligible to continue through the end of puberty? Or would they just – would you follow them until 210 is completed and perhaps a short time after that. Thank you.

[Rick Hawkins:]

Go ahead, Gene.

[Gene Kennedy:]

Yes. I mean our intention would be to allow those kids access to the therapies and to follow them as long as we believe and their physicians and families believe that it's beneficial. That's sort of the answer in a nutshell. But no, the 211 would be expected to live beyond the end of the OraGrowtH210 or OraGrowtH212 trials clearly.

[Ed White:]

Okay. Thank you for taking my questions.

[Operator:]

Next one on the line is Eun Yang from Jefferies. You are now live.

[Unidentified Analyst:]

This is Soo Jang Min on for Eun. Thanks for taking our question. Our first question is on the Phase 2b. I'm just wondering if you plan to do an interim look of the study and maybe just the number of patients based on that. And then second question is just kind of relevant to the first question, but based on the PK/PD study data, do you expect to adjust the Phase 2b trial design? Thank you.

[Rick Hawkins:]

John, do you want to take that first? John, I think…

[John McKew:]

Yes. I'm happy to answer that. So we don't think that an interim look at the data will be necessary for Phase 2b 210 trial. We also do not think that the PK/PD study results will influence in any way the design of the 210 trial. The PK/PD study is really about understanding more about the pulsatile nature of release. And it's going to be a separate study that's going to go along in parallel with the 210 trial.

[Unidentified Analyst:]

I see. And my last question is the ENDO 2021 presentation. Has this data been presented before? Just wanted to make sure.

[John McKew:]

No, that specific data has not been presented previously. That's in the abstract of the poster. No.

[Rick Hawkins:]

And Eun, we would be more than pleased to circle back with you to go over.

[Unidentified Analyst:]

Yes. That’s be great. Thank you.

[Operator:]

Next one on the line is Lina Kaminski from JonesTrading. You are now live.

[Lina Kaminski:]

Hi guys, thank you for squeezing me in. So I guess this one maybe for John. So you talked about the recent publication. So I really appreciate that. So I guess maybe you can elaborate a little bit further kind of what gives you the confidence and the support towards the ongoing 210 trial for LUM-201? And then also maybe just a little bit on the predictive enrichment marker strategy. I'm specifically kind of trying to understand the relationship between the standard growth hormone stimulation test and the stimulation test of LUM-201, the difference between the 2 nanogram per ml versus the 5. And then I have a follow-up.

[Rick Hawkins:]

John?

[John McKew:]

Yes. So let me take the last one first. So in the Bright manuscript, in Table 4, you'll see a correlation between the standard diagnostic stim test results and the LUM-201 stim test results. So we ran a receiver operator characteristic curve analysis on those data sets. And that's essentially the different stim tests in the same patient, right? And then we correlated what their response would be. And we're able to come up with this correlate that greater than or equal to five is similar to greater than two with a standard stim test. And then that's the PEM values that we applied to the GeNeSIS data set simply because they have standard diagnostic stim test data in the database, and none of those patients have taken the LUM-201 stim test. So that's the connection between those two papers in Table 4 of the Bright manuscript. So in terms of how do we feel – how do these two publications make us feel more confident about our potential success. I think first, we've been showing the results of the analysis for quite some time, but I think the scientific rationale and the approach that we took to derive the cutoffs is important to get out in all of its glory, so to speak. We just took a very scientific approach to do that. And I think it's very evident now in the Bright manuscript how deeply we thought about the data and how we worked very hard to find the right cutoffs, the right breakpoints in these two different parameters. And I think one way the Blum manuscript supports our PEMs is first, in the – in this patient population, it was shown very clearly that both baseline IGF-1 values and the growth hormone stimulation values were independent predictors of growth on – for recombinant human growth hormone. So that means essentially, what we want to do with these PEM markers is be able to predict how a child is going to grow. We know that if we can put them in a moderate group or a more severe group, they're going to grow at different rates. And the moderate group with a partially functioning axis is really the group that has the physiology to respond to our LUM-201 product, right? Because as a secretagogue, they have to be able to make some growth hormone, and then we're going to help them release it by continuing to stimulate that receptor. And because we can show that they're independent predictors of growth, they turn out to be very good markers to combine and use to separate patients into this PEM-positive or moderate category versus the severe category that are less likely to respond. So we like that aspect of that publication. It supports the choices we made to derive cutoffs from. I hope that answers your question, Lina.

[Lina Kaminski:]

Got it. Okay. Yes. That's really helpful. And I guess the last question I have is just more on kind of your strategy and how you're thinking about the patient population. So do you think – obviously, now you're enrolling naive patients. But how are you thinking about maybe switch population? Maybe patients that were previously treated with growth hormone, do you think that they might further benefit from LUM-201? And are you thinking of conducting a study like that?

[Rick Hawkins:]

Lina, it's a good question, and I think that anyone who has a product in this space eventually has to get around to that type of switch study. And we certainly will at the right time. Most important goal and objective in front of us is to get this dose to go into a registration trial after this study is over. And then the timing efforts for that study, we will focus in on. I think, John, the second part of her question, I think maybe the – whether there's any prediction on our part whether scientifically, we would feel that those patients being on long-term treatment and switch to our drug would also gain benefit.

[John McKew:]

So I think there is a history in – of exploring those switch patients with some of the long-acting growth hormones. And I think what is known is that the longer a patient stays on recombinant human growth hormone therapy, their growth is maintained, but it's not the same level of growth you see in those first six to 12 months' frame. So you would expect that you would take a patient on recombinant human growth hormone, kind of wash them out from their daily injectable for a while and then put them on treatment. Then I would expect they – if they meet our PEM criteria that they would be able to respond to the drug. You're going to get a slightly different growth rate from somebody who's been on recombinant human growth hormone for five years than you will at naive patients, right? It's important to understand that. And that's again the same with our molecule or any molecule that you put these kids on. But yes, I do think that if a switch patient meets our criteria, they will be able to respond to our molecule.

[Rick Hawkins:]

Operator, any other questions?

[Operator:]

Yes, we do have a question from Yasmeen Rahimi from Piper Sandler. You are now live.

[Yasmeen Rahimi:]

Thank you, team. First, before I ask my question, I just want to say thank you, Gene. It's been a pleasure working with you, and my team wishes you the best of luck in your next adventure. So it's been wonderful working with you. The – I have a set of questions. Maybe the first one I would like to start off is just discussing maybe the size of the open-label study, meeting with regulators, is there a certain safety data set that you require, and therefore, there's a certain requirement of patients to have an open-label extension? The second question is around the 211 study. Maybe highlight to me what the reason was for not running recombinant growth hormone is one of the groups rather than just two doses of LUM-201. And then I have a third pipeline question.

[Rick Hawkins:]

John, do you want to start?

[John McKew:]

Sorry. I think – so you asked, I think, about the 212 trial. You asked why isn't there a recombinant human growth hormone comparator in that trial. Is that correct? You said 211, I think, that's the trial.

[Yasmeen Rahimi:]

Yes, that's one of the questions. Yes.

[John McKew:]

Yes. So I think in that case, we're working on a study at a single site in Chile. And we wanted to make sure that we could recruit enough patients into that single site to enable us to really explore the two different doses of LUM-201 that are there. There's a decent amount of background or historical data on kids on growth – or kids with recombinant human growth hormone. We also know what the PK of recombinant human growth hormone looks like in kids, right. So the PK effect of recombinant human growth hormone is the same thing as the PD effect that we're going to look at in that trial. So because that PK curve is so well characterized and it's a single bolus dose, right, that is given at night and within eight or 10 hours goes away, we know very clearly what the difference in the look of the growth hormone being released is going to be for the comparator. So we didn't think that it was necessary, and we would rather focus on enrolling as many kids as we can in our treatment arms. Does that part make sense?

[Yasmeen Rahimi:]

Yes. No, that's helpful. And then in regards to the size of the open-label study that is needed for submission?

[John McKew:]

Yes. So the open-label study, I mean we're going to enroll any kid who's interested in continuing from any of our trials from the Phase 2b trial, the 212 trial or in an upcoming Phase 3 study into that, right? We like to get as much long-term data as we can. Gene – it was mentioned earlier that that's – we want kids on there as long as possible. There's potential for kids to go from puberty while on that study. So we'll collect a lot of data there. We don't have a fixed number in mind of how many we'd like to have. But we'd like to be as inclusive as we can. Anybody who is enjoying benefits from LUM-201 should certainly be able to have the opportunity to switch into that and stay on their treatment.

[Yasmeen Rahimi:]

So I just wanted to make sure that's, sorry, clear that there is no requirement of safety or additional safety data needed that prompted the open-label extension.

[John McKew:]

No. No, I mean the open-label extension is pretty common in all of these – in most rare disease studies, right? You want to build a database of kids who have multiple years of experience on the therapeutic when you get to an NDA filing. But there's no requirement upon us to do it. It just makes good sense, and it also is good for the patients. If they are – if they feel like the therapy is working for them, it makes a lot of sense to enable them to continue to take it.

[Yasmeen Rahimi:]

Great. Thank you for the clarity. And then the question on the pipeline one. Maybe you can comment on where you are in your licensing discussions and whether this is – we expect to see over the next quarter or two and/or whether expansion of the pipeline with LUM-201 could be happening ahead of in-licensing opportunities. So if you could just give us a little bit more granularity, it would be helpful.

[Rick Hawkins:]

Yes. Also, it's a good question. And the minute we can let you know, we will. We haven't given any guidance on where we are right now, but I can tell you, this whole process, it's a robust one. And it's led by an industry veteran with over 25 years of experience, and that's Aaron Schuchart. And I'm pleased with the – let's say, the number of opportunities, yet we are taking our time and being as cautious as we possibly can to find the right asset for this company. Obviously, we want to – we would like to stay in the endocrine space, but we're willing to throw a broader net and to look at other compounds or assets outside of endocrine. But I think it's a little too early to give any guidance right now.

[Yasmeen Rahimi:]

Thank you, Rick. Thanks for the color.

[Operator:]

Next one on the line is Elemer Piros from Roth Capital Partners. You are now live.

[Elemer Piros:]

Yes. Hello. Thank you for allowing for a couple of questions. Coming back to the thought experiment of using LUM-201 in previously treatment-experienced populations, would it also make sense, at least theoretically, that these children where there is a high degree of noncompliance with injections and therefore, there is subpar growth, and now suddenly, if there is an oral therapy available, daily oral pill, that their growth might catch up under that sort of regimen?

[Rick Hawkins:]

John?

[John McKew:]

Yes. And I think that's a very good point. You'll note in some of the publications about compliance that compliance tends to go down as kids get older and start to take more control of their own – they self-administer the drug instead of having their parents do it to them. The – so I do agree. In general, I think especially out in the real world, that's very true. A lot of the times the kids that you enroll in a clinical trial tend to just be very compliant because they seem to be the ones most interested in their growth because they're willing to sign up on a trial five years after their big growth peak or years after they started the therapy. But I do agree, there's – and there's quite an opportunity there for that population, which is most susceptible for low compliance.

[Elemer Piros:]

And John, just to follow up on the GeNeSIS data set, the analysis that you performed. So there appears to be in the moderate population that there is a 8.3 centimeter per year growth velocity, and more severe patients respond more robustly perhaps. Isn't it also true that at the end of the year, they would come to the same sort of normalized height, so their end – the end result, so to speak, would be very similar?

[John McKew:]

Yes, that's very true. And you can see that in the height SDS values after 12 months of treatment. There's no statistical difference between the severe group and the moderate group. So really, the severe group starts further behind, they grow faster, and then after 12 months, they're in about the same place as the moderate group. So even though the moderate group is growing at a different rate, they're both progressing in relation to their peers at the same rate.

[Elemer Piros:]

Okay. Thanks for picking me, guys.

[Operator:]

Thank you. I'm showing no further questions in the queue at this time. I'll hand the call over back to Mr. Hawkins for closing remarks.

[Rick Hawkins:]

Okay. Well, thank you for your interest, everyone. And we look forward to speaking with investors at the investment conferences this month and other venues in the coming year. Thank you very much.

[Operator:]

Ladies and gentlemen, this concludes today's conference call. You may now disconnect.