Lumos Pharma Inc (LUMO) 2023 Q2 法說會逐字稿

Good afternoon, and welcome to Lumos Pharma's Q2 2023 Financial Results Conference Call. (Operator Instructions) 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. Duke Pitukcheewanont, our Senior Vice President of Global Clinical Development and Medical Affairs will join for the question-and-answer session.

I will now turn the call over to Rick.

Thank you, Lisa, and good afternoon, everyone. After the market closed today, we issued a press release announcing our second 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 the highlights from the quarter and recent weeks before turning it over to Lori for a review of our financial results. Then, John McKew and Dr. Pitukcheewanont or Dr. Duke as we call him, will join us to answer your questions. Dr. Duke joined us about 1.5 years ago from Ascendis, where he worked on their long-acting injectable growth hormone therapy or therapeutic tool approval. He is also President of 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 preparation for our Phase III trial in Pediatric Growth Hormone Deficiency, or PGHD. So let's begin.

As reported this afternoon, during our second quarter of 2023, we made continued progress in advancing our oral therapeutic candidate LUM-201 and 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 the mechanistic PK/PD OraGrowtH212 trial in the fourth quarter of 2023.

And at this point, I'd like to remind everyone about our expectations for the primary readout. The primary endpoint for these trials is annualized high velocity or AHV at 6 months on treatment. And based on historical data, the predicted growth rate for LUM-201 is between 8.3 centimeters and 8.6 centimeters 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 for OraGrowtH210 cohort and up to 7 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 to the daily growth hormone control arm. And also, as is the case for all Phase II trials, the OraGrowtH210 trial is not powered to show non-inferiority of annualized high velocity between LUM-201 and the control arm, but should inform the design of and dose selection for a successful registration Phase III trial.

And as a reminder, the non-inferiority margin between the treatment arm and the control growth hormone arm for a pivotal of Phase III trial in this indication has historically been from 1.8 to 2 centimeters a year at 12 months on treatment. This has held true for recent approvals of long-acting growth hormone products as well.

So the next steps in the program, we're obviously engaging in meticulous planning for a Phase III trial. And 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. And based on regulatory precedents, we expect that this registrational trial will include approximately 180 to 200 PEM positive subjects, randomized 201 versus growth hormone with a likely dose of 1.6 mgs/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. And the trial will utilize the new LUM-201 formulation for which we filed a novel formulation patent application last November, enabled by the unique properties of our compound, which could extend our IP protection to 2042. This formulation of LUM-201 consists of many tablets and 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 U.S. 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 up to 7.5 and 12 years from the date of drug approval in the U.S. and Europe, respectively.

During the quarter, we were pleased to see further data and analysis from these 2 trials presented at the 2023 ENDO Meeting. Data from these 2 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 of the 12 months of LUM-201 administration.

There's 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/kg a day dose level 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 and at the 1.6 and 3.2 mgs/kg a day doses, are comparable in the growth each stimulate.

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 our 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 4 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 of Pediatric Endocrinology or ESPE, which will held in The Hague in the Netherlands, September 21 to 23. This abstract by Fernando Cassorla will include a deconvolution analysis of growth hormone accretion plus LUM-201 administration and the moderate PGHD population.

Now turning to other developments. We continued to support our clinical collaboration with Dr. Laura Dichtel in Massachusetts General Hospital to explore the potential of orally administered LUM-201 and nonalcoholic fatty liver disease or NAFLD. Positive results from this investigators 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 build-up in the liver in these patients with NAFLD. Subjects were randomly assigned to a treatment group, 27 growth hormone and 26 of placebo group with 41 completers overall, 21 growth hormone, 21 on placebo at 6 months.

Reduction in absolute percent 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, LUM-201 pilot trial in NAFLD continues to enroll. As a reminder, the company's primary near-term focus remains on advancing LUM-201 and 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 got a lot of work internally to assess the potential of LUM-201 in other indications in different geographic regions worldwide. And 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 U.S. and internationally. And 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.

So 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 of the date of the filing of our second quarter 2023 financial statement, which is well beyond our announcement of top line Phase II trial results in the fourth quarter of 2023.

This guidance is inclusive of estimated costs to be incurred in preparation for Phase III trials included 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.

Thank you, Lori. So to recap, we can confirm our plan to report top line data from both OraGrowtH210 and OraGrowtH212 trials in the fourth quarter of 2023. New interim data analysis presented at ENDO and other medical meetings this year further reinforced our confidence that primary outcome data from these 2 OraGrowtH trials should achieve the predicted annualized high 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 for non-inferiority to growth hormone of approximately 1.8 to 2 centimeters should determine success based on historical approvals.

Our novel formulation of OraGrowtH201 should also facilitate adherency 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 or initial clinical studies have shown growth hormone treatment to be beneficial. And 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.

And finally, in September, we plan to host both a KOL panel webinar and a KOL dinner where noted Pediatric enteprologists 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 fourth quarter of 2023. So thank you very much for your time today.

And operator, we're ready to take questions.

(Operator Instructions) Our first question is from Yasmeen Rahimi of Piper Sandler.

Thank you so much for all the updates. I guess, could you maybe comment on how soon post OraGrowtH readout. You could be in a position to kick off the Phase III study. Maybe also some color on if you've started warehousing patients for the Phase III and help us around enrollment time lines?

And then third, when do you hope to get color in regards to the patents, the patents that are filed with the new formulation? I appreciate color on those topics.

John, I'm going to let you answer the first question that she has asked.

Yes. Right now, we're focused on thinking through all the steps to get from the data readout in the fall all the way out to the end of Phase II meeting, an agreement with the FDA on our Phase III profile, right?

So there's a lot of work involved there in integrating the data from these 2 studies, making any necessary adjustments to our Phase III clinical plans, putting together briefing book, waiting the 60 days to get the meeting and then hopefully quickly coming to agreement with FDA on what that Phase III protocol is going to look like.

And really from then is when we'll start to kick off really the extent of our focus on bringing trial sites up and getting ready to go. We've done a lot of the Phase III work as much as we can. We're working on that right now. But we really need to get that final agreement on the protocol, really to start kicking things off and getting sites to be thinking about patients.

Remember, the patients that we need are naive to treatment. And so it's a little bit early right now to -- you can be watching patients. But I think going any further than that we want to hold off on.

In terms of the patents that we filed this patent in November of last year, right? So a 12-month decision time is not -- it's kind of an expected time of time line for when we might hear back on that patent.

And yes, let me just add. We have been obviously a really experienced clinical development team. We've really performed well in this the 210 and 212 trials and the extensions for those trials in terms of time to enrollment.

And I think that is due to 2 things. Number one, a highly experienced, motivated staff has really managed these trials quite well. And the second thing is that 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. And so we get a lot of attention. I might add one other point and that is you think about the typical time that takes to enroll a full 180, 200 patients. And historically, you look at the companies who have done that in the long-acting space.

And they were all enrolling in a Phase III in competition with each other. They're finished with those studies are either obviously this products were approved, while we had certainly expect there's going to be some competition for these patients. We believe it's going to be a lot less than there was before.

And therefore, we think enrollment is going to go well. But I -- maybe I'll just ask Duke to comment here because he's really been instrumental in his connection with all these highly experienced sites.

Thank you, Rick. So let me touch base with timely and enrollment, which is, again, most of their Phase III trial. That's one of the big hurdles that most companies have experienced, right? It might connection with the KOL around the world with experience they have done in the past.

We hope that we actually have well prepared site initiation and potentially could start up site enrollment across the world as pretty much at the same time line. We'll be able to cap down the number of recruitment and time line of complete enrollment. But again, a lot of factors involved. But we will do our best based on strategic planning, as John had mentioned.

Our next question is from Leland Gershell of Oppenheimer.

And for the comprehensive framing of how to think about things as we head into the readout later this year. A couple of questions from me. First, with respect to -- obviously, 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?

And then number two, as we look forward to the SP Conference, you mentioned there would be some additional analyses of the prior study. Just wondering if you could share what the nature of those additional analyses might be?

John, do you want to start with the PEM and the SP analysis?

Sure. Leland so the PEM test has been very effective in as, an, inclusion criteria in the 210 study. We spent a lot of time educating the clinicians in that study as to which subject to screen to bring into the trial. And our success rate at inclusion is actually quite high, right?

We got -- we had originally said in the entire population, about 2/3 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 to kind of fit, but the criteria of that slice of the patient population. So we're getting a very high number of kids who are PEM positive versus what you would expect from just looking at the epidemiology data of the whole spread of growth hormone deficiency.

The second question about the ENDO -- or I'm sorry, the SP meeting. So we've given out the title about the deconvolution analysis of the 212 study. So essentially, it's focused on the 212 study; and deconvolution of the PD data that is there. Those abstracts haven't been published yet, but the program has been announced.

So I think we'll have to wait until they publish the abstract to get a little bit more information if that was going to be released there. But from the title, that's give you a good sense of what's in there.

Our next question is from Ed White of H.C. Wainwright.

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 to 200 patients? And how is the split going to go between U.S. sites and ex-U.S. sites? And also, how are you thinking about the patient population, same question, U.S. versus outside the U.S.?

John, do you want to start?

So we haven't released the total number of sites. We're kind of deep in discussions with CROs and trying to get their input on what they've seen in the past. Obviously, we're reviewing what some of the folks in these successful long-acting programs have done. So we haven't really -- we haven't decided on a firm decision on a number of sites.

Obviously, we are going to do a global trial, as we've talked about. I think it's important. We do expect to get different recruitment rates in different regions depending on access to growth hormone. And so I think we have to put all those together. In terms of what the FDA wants, obviously, I think we can certainly use almost all the U.S. and European sites are quite acceptable.

And I think some of the Asian countries have requirements for which patients have to be or what number of patients have to be enrolled. So I think we're working through all those thoughts right now. We don't have a final plan with, but they are all things that we're thinking through.

Yes. Let me just continue with that, Ed. The benefit of being on the podium at all of these endocrines meetings around the world is that all these experienced investigators have really attended those meetings with a great deal of interest because of us being the 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 offering to be clinical sites. I don't think there's going to be a problem in choosing the sites. In fact, we have the benefit of more recent historical entry rates from recently just completed trials by site. And Duke, of course, has a great deal of experience in that. So I think that's going to be much to our benefit.

Okay. And perhaps a question on what's next for the company? You had mentioned that next indications are ISS and PWS. How should we be thinking about that? Are you prepared to run perhaps a Phase I study concurrently with a Phase III study that we've just been discussing? Or would this be something that you're thinking about post Phase III data?

Ed, I think that to answer the question is if we are a large company, we probably have a different plan. The capital markets are where they are. As we go out and do all the advanced planning for our Phase III, that's where we're going to be focused.

If the capital markets are going to permit us to raise the appropriate amount of money over time, then, we're going to start about 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 the stage into Phase II, into Phase III, regional partners show up or at least that's what our partners of all time.

And as I think our Head of Business Development is a pretty busy guy at this stage. And we're going to, I think, have some choices here person to look at some partners that could help us advance the program. And that could be in other indications, too, although we certainly haven't had those discussions with anyone yet.

And 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 take it a onetime event. And we should be thinking about the run rate more like the first quarter?

I think our research and development expenses for Q2 were pretty on par with what we should expect even going forward, 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 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 there.

Our next question is from Catherine Novack of JonesTrading.

Just a question on some KOL issues. What we've heard time and again is that the real focus in PGHD is 12, 24 months and beyond. And 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.

And then how should this change our expectations for what we should see in the data in Phase II and Phase III?

Well, thanks for that excellent question, Catherine. And John, will you answer that?

Sure. So 2 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? And we'll hopefully keep as many kids as we can in that trial and transition kids from the Phase III into an extension trial as well.

So 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. And that's the same data package that all the long-acting have brought in. That said, you can look at the difference in growth or look at the difference in annualized light velocity for individual patients between -- at 6 months, at 12 months, at 18 months and look at the slope of that decline.

And as you said, it's well documented. That growth hormone has its kind of biggest peak in the 3 to 6-month range. And then every year after that, you get a decline. You don't get the same growth every year, right? You get a decline in return. LUM-201 has been shown in adults. It's been published in adults. But you can elevate IGF-1 growth hormone levels out to 24 months, right, so in adults that changed body composition. We get that same level of continued elevation in kids. We would expect to see a continued growth, right?

And I think some of the early data that we're going to reveal at the end of this year on the handful kids past 12 months will really start to help put those pieces together for us. But there are certainly scenarios, where you could expect that we're going to modulate kids to a more natural growth pattern. And that could be a much flatter growth slope than what you might see with kind of the pharmacological or super-physiological levels of injectable growth hormone. Thank you for that question.

Yes, of course. And then, just one more. Now that we've got a couple of weekly injectables in the market for PGHD, 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?

Catherine, look, there's no question that it's going to be a highly competitive space. And you look at the price on a monthly basis between the 3 growth hormones -- long acting growth hormones is something like $7,000, $8,000 and $9,000 per month, all that to nearly cost of over $100,000 for a 35 kilo kid. That's expensive treatment. I think there are certain parts of the world where the standard of care is going to continue to be a daily because the restrictions in price were longer time to approvals in different markets around the world.

We believe -- I mean, we've done our market research. We've asked the question both to Pete ENDOs and the parents, if you had a choice between a weekly injection, or daily oral, they overwhelmingly say they would choose a daily oral. And on top of that, I'm going to remind you, we're a small molecule on our cost of goods and our flexibility and pricing and margins is -- looks very favorable to us long term in this market.

Well, Catherine, may I add with the feedback from the KOL in that regard. Retention about the pricing, that's a very important, right? It's more expensive than daily. The other issue that the KOL has some skeptical is a 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 looked at efficacy itself. The long-term side effect, which is, again, is very unclear at the short term, right? When you look at the profile, the growth hormone exposure for weekly growth hormone is much higher than daily growth hormone and also higher IGF-1.

With that said, long-term post-paid post-study on the post-marketing study need to continue in order to show of the safety profile in the long-term fashion. So that's something that some KOLs still quite skeptical to really put all subjects in weekly [growth hormone] therapy in regards to efficacy itself, right? So not to mention, it's very expensive.

Yes. And Catherine, recall, our mechanism of action is very different from growth hormones. We stay within the natural endocrine feedback loop. And those excursions you get with of higher levels of growth hormones with especially the long-acting, is not possible with our drug. We -- once again, that feedback loop stays within the natural physiology.

Our next question is from Pete Stavropoulos of Cantor Fitzgerald.

Team, nice to see all the progress made this quarter and movement towards data readout by year-end. Question -- first question, when you look at the data that you've generated to date using the PEM, the Predictive Enrichment Marker and the growth that you've observed in these patients.

Just curious to know, as you move into a later larger study, if you expect to keep a cut-offs to where they currently are? Or do you think you can increase the probability of success by focusing or enriching patients with a greater response or is the current algorithm sufficient?

Pete, thank you for that good question and John why don't you start?

I think, Pete, we're comfortable with the enrichment that we're getting from using our PEM markers right now. But obviously, we haven't looked at all the data yet. So we've to look at the HV data for the other half of the patients that have come in. But I think we feel pretty confident based on the analysis that we originally did and as well as how things are rolling on to.

Okay. And as you think about a Phase III design, I understand that you need to -- your end of Phase II meeting and to come to an agreement with the agency. However, are there any modifications you might make to enrollment or trial design for a pivotal study based on the accumulating data from 210 and 212?

John, why don't you start with that question?

No. I think the Phase III design and basic kind of inclusion characteristics are pretty common across all the 3 long-acting products that have been successful and are pretty much how we would go forward. Obviously, our patient population has to be PEM-positive, that's a distinction. But other than that, I think the time line and the approximate ends, I think, are pretty close to what we would expect after we do the analysis at the end of the study. So we don't see any radical departures from those that have gone before this year.

Okay. And last question is directed towards Duke, both Rick, John, more than welcome. So you've presented -- Lumos presented a number of times at different endocrinology meetings most recently at ENDO 2023. So, just wondering, when you speak to KOLs, some of your former colleagues and even practicing clinicians about LUM-201, it's a mechanism of action and how it may be differentiated from standard of care. Just curious to hear what the reception of this candidate and approaches and the data presented to date.

Yes. And so Duke, why don't you go ahead?

Yes. So actually, it's very, very positive. As you may know, right, this is oral growth hormone have been proposed for the treatment for years. But none of those trials have been successful. So here is the LUM-201, which is mechanism of action of the drug itself is somewhat different shape in itself from the oral growth hormone equating peptide or security block out there, right?

They have long acting. You generate IGF-1 that sustained. And based on the presentation at PES 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 of the loss is somewhat matched. And we looked at the combined data tried to see that what the response looks like. It seems like the dose that had been selected, especially 1.6 and 3.2 is pretty comparable and you can see those data in the 6-month and 12-month result.

But again, it's a very small number. But most of physicians really feel intrigued about the data. They did not know that this growth hormone -- are also will work as good, right, and 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.

And again, we expect that the burden injection with the majority of those patients suffering from daily (inaudible) could be somewhat overcome by this new therapy. But again, overall, it's very, very positive. They all just need to look 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 when we do these presentations at IMPE in March, and [CES] and at ENDO, they're inspected, right? And there are lots of good questions, lots of excitement, lot of people wanting to talk to the presenters about this product. So one-on-one and then in the lecture halls, we see a lot of excitement and a lot of curiosity.

Yes. And I might add, Pete, that we always have a booth at each one of these meetings. And right alongside of all the competitors in the growth hormone space. And I am absolutely amazed at the level of interest and the number of really great questions and just overall excitement that everybody feels, oh, the fact 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.

I'm showing no further questions on the line. This concludes the Lumos Pharma second quarter earnings call. Thank you and have a great day.