Q2 2023 Lumos Pharma Inc Earnings Call
Okay.
Good afternoon, and welcome to little more pharma Q2, 2023 financial results conference call.
All participants are in a listen only mode.
Later, we will conduct a question and answer session and instructions will follow at that time.
As a reminder, this conference call is being recorded.
I will now turn the call over to Lisa Miller Senior director of Investor Relations.
Thank you operator before we proceed with the call I would like to remind everyone that certain statements made during this call are forward looking statements under U S. Federal Securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present.
<unk>.
Additional information concerning factors that could cause actual results to differ is contained in our periodic reports filed with 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 thinking 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 Hough, CEO , and chairman and Lori Lally our CFO .
John Mchugh, our president and Chief Scientific officer, as well as Dr. Richard <unk>, Our senior Vice President of Global clinical development and Medical Affairs, who will join for the question and answer section I will now turn the call over to rich.
Thank you Lisa and good afternoon, everyone.
After the market close 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 will keep our prepared remarks on today's call brief. So we can maximize the time available for Q&A.
I'll touch on the highlights from the quarter in recent weeks before turning it over to Laurie to review of our financial results.
And John Mchugh and Dr. <unk> <unk>, our Doctor, Duke as we call him who joined us to answer your questions.
Dr. <unk> joined us about a year and half ago from the centers, where he worked on their long acting injectable growth hormone therapy or therapeutic to approval here.
He is also president 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 <unk> trial and in the preparation for our phase III trial in pediatric growth hormone deficiency or PTSD.
So let's begin.
As reported this afternoon during our second quarter of 2023, we made continued progress in advancing our oral therapeutic candidate Blu 201, and moderate idiopathic P. G AC.
We can confirm our expectation to report primary outcome data on Arctic 82 subjects in the dose range, finding or about <unk> trial and after 'twenty two subjects.
Kinetic PK PD or growth to 12 trial in the fourth quarter 2023.
And at this point I'd like to remind everyone about our expectations for the primary readout.
The primary endpoint for these trials.
Height velocity, where HP at six months on treatment.
And based on historical data.
<unk> growth rate balloon to zero, one is between eight three centimeters and $8 six centimeters per year forget moderate GDP did USD population.
Going to observe growth in <unk>.
Several large historical databases.
The other objectives, Uruguay to Gen trial are to confirm the utility of the predictive enrichment marker where PGM strategy.
And to determine the optimal dose for our phase III trial.
We also expect our primary outcome readout to include HP data at 12 months on treatment for up to 12 subjects per all of R. R.
Mechanical cohort after seven subjects for oil growth to 12 cohort for a total of up to 62 subjects from both trials.
Additional HP data.
And 24 months on treatment are also expected for a small number of subjects.
In addition, the phase II trial should demonstrate the safety profile comparable are comparable to the daily growth hormone control arm.
And also as is the case for all phase III trials.
The oil growth 210 trial is not powered to show non inferiority of annualized height velocity between linked to zero, one and the control arm should inform the design of and dose selection for successful registration phase III trial.
And as a reminder, the non inferiority margin between the treatment arm and the control growth hormone arm for our pivotal phase III trial. In this indication has historically been from one eight to two 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 and meticulous planning for our phase III trial and after a thorough review of the data package. The first step would be.
We 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 precedent. We expect this registrational trial will include approximately 180 to 200 PM positive subjects randomized two to one versus growth hormone without likely dose of one six mix per kg of <unk> zero, one to daily growth hormone.
Stratified by age and other factors.
To ensure balanced cohort.
Our proposed primary endpoint will be HP at 12 months on therapy and the trial will utilize the new look to zero, one 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.
2042.
This formulation of <unk> consists of many tablets and capsules, which we believe will provide easier oral dosage form from a wide age range of our target population.
We expect to hear from the U S patent office later this year.
Currently <unk> has patent protection through 2036, plus applicable extensions for the detection and treatment of growth hormone deficiency.
As well as orphan drug designation, which offers extended protection for up to seven 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 two trials presented at the 2023 Endo meeting.
Data from these two.
Abstracts were presented including new data from the <unk> trial.
An increase of IGF, one levels on Luke's who zero one at six months.
Remained within normal range.
The increase in IGF, one Sds greater than zero.
Verbal growth response up to 12 months of room 201 administration.
Clear evidence of potential drug effect for Luka Zero, one was also observed and consistent improvement in HB over baseline.
Also new analysis of combined or growth to 10 and order a controlled trial data at the one six and the $3 two mixture take a day dose levels.
<unk> subjects from Oregon to 12 20.
<unk> 20 subjects in the order of 210.
These combined results continued to demonstrate that there is a durable response to learn to zero one from six to 12 months and at the one six and $3 to make strategic a day doses are comparable and the growth each stimulated.
As many of you know these data were highlighted in a key opinion leader Webinar. We hosted on June 21, where doctors Fernando Cazorla macro P&C share their insights on the data and our continued conviction in the potential of <unk> zero one to become the first oral.
Therapeutic to address this patient population increase solely by injectable therapies for the last four 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 orbit 212 trial was accepted as a late breaking abstract for oral presentation at the upcoming annual meeting of the European Society of pediatric Endocrinology, where SP, which would help in the Hague in the Netherlands September 'twenty, one to 'twenty three.
This abstract by Fernanda Cazorla will include a decomposition analysis of growth four months accretion was wound to zero one administration in the moderate PGA PUC population.
Now turning to other developments.
We continued to support our clinical collaboration with Dr. Lord <unk>, Taylor, and Massachusetts General Hospital to explore the potential of orally administered <unk> 201.
Non alcoholic fatty liver disease are novel.
Positive results from this investigators prior trial evaluating injectable growth hormone and Apple were recently published in the journal of clinical endocrinology and metabolism.
It was these compelling data that encourage Dr Patel and mass general to initiate the collaboration with numerous pharma to assess oral <unk>, one and the same indication.
And the prior study investigators department size that growth hormone might reduce hepatic steatosis or fat buildup in the liver <unk>.
These patients with Napoli.
Subjects were randomly assigned to a treatment group 27 growth hormone and 26% placebo group with 41 complete our overall 20 on growth from 'twenty, one on placebo at six months.
Reduction in absolute percent commensurate paddock lipid content by proton magnetic resonance spectroscopy with significantly greater than the growth hormone versus the placebo cohort.
Investigators concluded had growth hormone reduces liver fat without commensurate weight loss.
These data are.
Our supportive of evaluation of oral wound to zero, one and the Napoli indication.
201 pilot trial, and therefore continues to enroll.
As a reminder.
The company's primary near term focus remains on advancing low to zero, one and PGA ste.
Now as previously mentioned, we believe that <unk> 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 linked to zero, one and other indications and different geographic regions worldwide.
And as we've said before we narrowed our focus to <unk>.
Pathic short stature or ISS, and <unk> 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.
Ensuring our capital allocation is focused on advancing our core program.
With that I'm going to turn it over to Laurie for a review of our financial results Laurie.
Thank you right Raimo pharma ended the quarter on June 30 of 2023 with cash cash equivalents and short term investments totaling $50 9 million compared to $67 4 million at December 31, 2022.
We reiterate our expectation for average cash used approximately nine to $10 5 million per quarter through 2023.
Equivalence and short term investments as of June 30 of 2023 are expected to support operations through at least.
The date of the filing of our second quarter 2023 financial statements.
We'll be on.
Top line Phase III trial results in the fourth quarter of 2023.
Guidance is inclusive of estimated costs to be incurred in preparation for phase III trials.
Estimated cost for clinical trials.
Jason.
As far as manufacturing expenses and regulatory fees.
Cause may change, depending primarily on the Oregon.
And subsequent of feedback from regulatory agencies.
Good.
Anthony.
Jim.
Great.
Thank you.
Primarily due to increases of $1 1 million in contract manufacturing expenses.
$4 million of clinical trial expenses $1 million in personnel related expenses.
The decrease in consulting expenses.
General and administrative expenses increased by 25 million for the three months and that changed our view of 2023 compared with same period in 2022, primarily due to increases.
And personnel related expenses.
And stock compensation expenses.
And travel expenses.
$1 billion in royalty expenses.
Loss for the quarter ended June 30th 23 was $8 5 million compared to a net loss of $7 8 million the same period in 2022.
So I agree with you.
41340 <unk>.
With that I'll turn the call back to Rick.
Okay.
Alright. Thank you Laurie so to recap we can confirm our plan to report top line data from both <unk> and <unk> 212 trial in the fourth quarter of 2023.
New interim data analysis presented at Endo and other medical meetings. This year further reinforce our confidence that primary outcome data from these two <unk> trials should achieve that predicted annualized height velocity at six months on treatment.
Line with historical averages of eight three to $8 six centimeters a year for this moderate idiopathic PTSD population.
There are phase II trials are not powered to show non inferiority primary outcome data from these trials should support selection of <unk> zero, one dose for a registrational phase III trial, where non inferiority to growth hormone of approximately one eight <unk> readiness.
Should determine success based on our historical approvals.
Our novel formulation of oil growth to zero, one should also facilitate adherence to treatment protocols and both this pivotal trial and in the commercial setting.
If a new patent is granted will extend IP protection beyond our current 2036 exploration date.
We believe oral loom to zero, one represents a platform therapeutic with a potential not only to disrupt the current worldwide $3 5 billion.
Growth hormone market accretive 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 novel, where 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 PTSD.
The capital to support that effort well beyond our primary outcome readout later this year.
Finally.
September we plan to host a KOL panel webinar.
Rob dinner, where noted pediatric endocrinologists will discuss their experience with P. J C patients the therapeutic landscape and the potential for an orally administered therapeutic to address other indications currently treated by injectable growth hormone.
Excited to continue to advance our clinical programs and look forward to disclosing topline data in the fourth quarter of 2023.
So thank you very much for your time today and operator.
Ready to take questions.
Thank you the lines are now open for questions to ask a question. Please press star one on your telephone and wait for your name to be announced.
So we would draw your question. Please press star one again.
Please standby, while we compile the Q&A roster.
Our first question is from <unk> Rahimi of Piper Sandler.
Your line is now live.
Hi, good afternoon team. Thank you so much for all the updates.
Hey, guys.
Could you maybe comment on.
How soon post the order growth greed out you could be in a position to kick off the phase III study.
Maybe also some color on if you had started warehousing patients for the phase three and help us.
Around you know.
Enrollment timeline.
Third.
When do you hope to get color in regards to asking the.
<unk>.
Kyle with the new formulation.
Hum.
I appreciate the color on those topics. Thank you again.
John I'm going to let you answer the first question, yes ask.
So yes, right now we're focused on thinking through all the steps to get.
The data read out in the fall all the way out to the end of phase two meeting.
With the FDA on our phase III protocol right. So there's there's a lot of work involved there and integrating the data from these two studies.
Any necessary adjustments to our phase III clinical plans.
Putting together a briefing book waiting the.
60 days to get the meeting and then hopefully quickly coming to agreement with FDA.
What that phase III protocol is going to look like and really from then that's when we'll start to kick off really the.
The extent of R. R.
Focus on.
Bringing trial sites up and getting ready to go we've got a lot of the phase III.
Pork is as much as we can we're working on that right now, but we really need to get that that final agreement on the protocol really just start kicking things off.
Getting getting sites to be thinking about patients remember the patients that we need are naive to treatment.
And so.
Little bit early right now.
It can be watching patients, but I think going any further than that we would want to hold off on.
In terms of the.
The patents that we filed this patent in November of last year right. So 12 months decision timing is not.
Is that.
It's kind of an expected times a timeline for when we might hear.
<unk>.
Pat.
So let me let me just add.
We have and obviously a really extent.
Turning to development team.
We've really performed well in this.
10 to 12 trials and the extensions of those trials.
In terms of time to enrollment and I think that is due to two things number one.
Highly experienced motivated staff.
Hi.
Is really manage these trials quite well.
And the second thing is that 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 PTSD as shown up so theyre 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 it takes to enroll full 180 to 200 patients in historically.
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 are finished with those studies are obviously out of those products are approved.
While we certainly expect is there'll be some competition for these patients.
We believe there's going to be.
A lot less than there was before.
And therefore, we think enrollment is going to go well.
Maybe I'll just ask the Duke.
To comment here because.
He has really been instrumental and his connection with all of these these are highly experienced sites.
Thank you Rick So let me touch base with the timeline and enrollment which is again most of their phase III trial. That's one of the big hurdle that most companies have experienced.
It might.
Connection with the Kols around the world with Experian to have done in the past we hope that.
We actually have well prepare site initiation and potentially could start up site enrollment across the world.
It's pretty much at the same time lines will be able to kept out that number.
<unk> and time lines complete enrollment, but again, let us after in BOE, but we will do our best based on strategy planning as John had mentioned.
Got it. Thank you guys does that answer your question in the queue. Yeah that was very helpful. Thank you team.
Thank you.
Thank you one moment please for the next question.
Our next question is from Leland <unk> of Oppenheimer. Your line is now live.
Hey, guys.
Thanks for taking my question.
The comprehensive framing.
Think about.
Things as we head into the Readouts later this year.
Couple of questions from me.
First with respect to.
Obviously.
We look forward to the data from our growth to turn.
Next quarter wondering if you'd be able to share.
The Perm.
Screening results or do you have any color to.
Whether thats the rates of.
Success, you've been seeing with the tenant screening have aligns with.
What's your expectations and then number two.
As we look forward to the <unk>.
Conference you mentioned, there would be some additional analyses of the.
The prior study I'm just wondering if you could share with the nature of those initial analysis must be thank you.
Alright, John do you want to start with the PM and DSP analysis.
Sure. Thanks for the question Leland so.
The pm tests.
Has been very effective.
And.
That's an inclusion criteria in the 210 study.
We've spent a lot of time educating.
Clinicians in that study as to which.
Subject to.
To screen to bring into the trial and our success rate at inclusion is actually quite high alright got.
Got it.
We had originally said in the entire population about two thirds of the kids would be positive.
We're actually seeing a much higher number.
Oh.
Test returning positive values simply because of how the clinicians are focusing their efforts in looking for patients looking towards the more moderate end of the spectrum.
And kids, who kind of fit that criteria.
That slice of the patient population, so we're getting a.
A very high number of kids, who are <unk> positive versus what you would expect from just looking at the epidemiology data that the whole spread of personal deficiency.
The second question about the Endo.
I am sorry, the SPE meeting so.
Given out the title about the deconvolution analysis of the $2 12 study.
Essentially it's focused on the 212 study and decomposition of the PD data.
That is there those abstracts haven't been published yet but the.
The program has been announced so I think so.
To wait until they publish the abstract to get a little bit more information about what's going to be released.
From the title that should give you a good sense of what's in there.
Great. Thanks for thanks for taking the questions and I look forward to the updates.
Thanks for the question Leland.
Thank you one moment please for the next question.
Our next question is from Ed White of H C. Wainwright. Your line is now live.
Hi, Thanks for taking my questions.
Just going back to the phase III study.
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 the same question.
<unk> versus outside the U S.
John you want to start.
So we Havent released the total number of sites, where kind of deepen discussions, but zero as I'm trying to get their input.
What <unk> seen in the past obviously, we're reviewing what some other folks in the successful long acting programs have done so we haven't really.
We haven't decided on that.
Affirm.
Decision out of the number of sites, obviously, we arent going to do a global trial and so 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 <unk> 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.
No.
Most all of it.
The U S. European sites are quite acceptable and I think some of the.
Asian countries have requirements.
For which patients have to be have to be or what number of patients to be enrolled. So I think we're working through all those spots right. Now we don't have a final plan yet, 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 interim meetings around the world.
Is that all.
All of these experienced investigators have really dependent.
Those meetings.
With a great deal of interest because.
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 have been reaching out to us and offering to be clinical sites I don't think theres going to be.
Our problem in choosing.
In fact, we have the benefit of more recent historical entry rates from from recently just completed trials.
By site and.
Look of course has a great deal of experience in that so I think that's going to be much to our benefit.
Okay. Thanks, Rick and perhaps a question on what's next for the company you had mentioned that next indications our ISS and gws.
How should we be thinking about that are you prepared to run.
Perhaps the phase one study.
Currently with a phase three study that we've just been discussing or would this be something that youre thinking about post.
Phase III data.
And I think that answer that question.
If we were a large company, we probably have a different plan.
Capital markets are what 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 <unk>.
Programs.
Other programs, perhaps sooner than we normally would plan them.
In addition to that typically what happens when companies and their development plans get to the stage at the end of phase II into phase III.
Regional partners show up or at least that's what we're partners of all types.
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.
Krishnan to look at some partners, who could help us advance the program.
And that could be in other indications too although.
We certainly havent havent had those discussions with anyone yet.
Great. Thanks, Rick and perhaps a question for Laurie just when thinking about R&D.
Moving into the back half of the year, you mentioned that $1 1 million and 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.
And I think you are.
Our research and development.
For Q2 are pretty.
No pretty on par with what we should expect Leland going forward not not Jonathan contract manufacturing expenses bird offer in clinical.
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.
R&D, we expect overall R&D and G&A operating expenses to be between.
At this point.
Okay. Thanks, Laurie Thank you everyone for taking my questions.
Thank you Ed.
One moment please for our next question.
Our next question is from Katherine <unk> of Jones trading your line is now live.
Hi, good afternoon, everyone.
Just.
Question on <unk>.
K O L issues, what we've heard time and again is that their real focus in N P. J, it's Steve.
24 months and beyond and we hear with Tennessee injectable growth hormone.
Anyway after about the first year. So given the mechanism of action is it safe to say you wouldn't expect us to be so dramatic with one to one and then how should this change our expectations for what we should see in the data in phase two and phase III.
Yes, thanks for the excellent question Catherine.
John would you answer that.
Okay.
Sure so.
Two things to keep in mind.
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 and we will.
Keep as many kids as we can in that trial and transitioning 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 six and 12 months and that's the same data package that all the long acting <unk> brought in.
That said you can look at the difference in growth.
Look at the difference in annualized height velocity for individual patients between at six months at 12 months at 18 months and look at the slope of that decline.
And as you said, it's it's well documented that.
Growth everyone hazards.
Biggest peak in the three to six month range and then.
Every every year after that you get a decline you don't get the same growth every year right you've got a decline in <unk>.
Return.
Yes.
<unk> has been shown in adults.
Published in adults, but you can elevate IGF.
Hi, Jeff on the growth of our levels out to 24 months. So in adults that change body composition, we get that same level of continued elevation in case, 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 of kids past 12 months will really start to hit.
Ill put those pieces together for us.
But there are certainly scenarios, where you could expect that we're going to modulate kits 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.
Injectable growth.
Thank you for that question.
And that of course.
And then one more.
Now that we've got a couple weekly injectables in the market for Gvhd, 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 heirloom kilowatt and market expectations at all.
No.
Catherine.
Look there is there is no question that that this could be a highly competitive space.
And you look at the price on a monthly basis between the three growth hormone long acting growth hormones is something like 7%, 8% $9000 per month.
All of that to you.
The cost of.
Over $100000 or 35 kilo kit.
That's expensive treatment.
There are.
There are certain parts of the world, where the standard of care is going to continue to be a daily because the restriction in price.
Longer time to approvals in different markets around the world.
We believe I mean.
We've done our market research we've asked a question both to Pete and dose and the parents. If you had a choice between a weekly injection or daily oral they overwhelmingly say they would they would choose a daily oral.
And on top of that and I'll remind you, we're a small molecule or cost of goods and our flexibility in pricing and in.
And margins.
It looks very favorable to us long term in this market.
Look Kathleen.
That was the feedback from the Kao al industry regard with the uncertainty about the pricing that is a very important rate is more expensive than daily. The other issue that I will have some skeptical is the safety data profile as you would note that in order to get approved FDA you only have 12 months safety data however, long term.
Safety, especially long acting not only look at efficacy itself the long term side effects, but just again.
And clearly at the short term right, which isn't gap profile court one exposure.
Four weekly growth hormone, it's much higher daily growth hormone and also higher IGF, one with that said long term.
Postpaid both steady on post marketing study need to continue in order to show the safety profile and the long term fashion. So that's something that some key al still quite skeptical to really put all subjects in weekly godman therapy in regards to efficacy rate so as not to mention it.
They're expensive.
Yes, and Ken.
Recall, our mechanism mechanism of action is very different from growth hormone we stay.
Within the natural and Hurricanes feedback loop and those excursions you'd get with <unk>.
Higher levels of growth hormone.
With especially the long acting is not possible with our drug.
Once again that feedback loop.
Stays within the natural physiology.
Okay. Okay. That's.
That answered my question, thanks very much.
Right.
One moment please for our next question.
Hi.
Our next question is from Pete <unk> of Cantor Fitzgerald. Your line is now live.
Hi, Rick and team nice to see all the progress made this quarter and movement towards data readout by yearend.
A question first question is when you look at the data that you've generated to date using the patented predictive enrichment marker.
And the growth that you've observed in these patients just curious to know as you move into a later largest study.
If you expect to keep the cutoffs, where they currently are or do you think you can increase the probability of success by focusing on reaching patients with the with a greater response.
Or is the correct algorithm sufficient.
Okay.
Pete Thank you for that good question and John when you start.
I think Pete where we're comfortable with.
Okay.
The enrichment that we're getting from using our patent partners right now, but I haven't seen.
Haven't looked at all the data yet right. So you can look at T. H eight data for the other half of the patients that have come in but.
We feel pretty confident.
Based on the analysis that we originally did as well as helping.
How things are rolling out now.
Okay.
As you think about a phase III design I understand that you need to.
End of Phase II meeting and I'll have to come to an agreement with the agency. However are there any modifications you might make to enrollments our trial design.
For a pivotal study based on the accumulating data from 210% to 12.
John wanted to start with that question.
No I think the.
The phase III design and basic kind of inclusion characteristics are pretty common across all the.
The three long acting products that have been successful.
R.
Pretty much how we would go forward, obviously, our patient population has to be positive.
That distinction.
But other other than that I think.
The timeline.
Proximate ends I think are pretty pretty.
Pretty close to what we would expect after we do the analysis at the end of the study. So we don't we don't.
See any radical departures from.
From those that have gone before us here.
Okay.
I'm sorry go ahead.
No go ahead. Please go ahead and last question directed towards Duke risks John more than welcome.
So you've presented.
With luminous presented a number of.
Times have 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 one 201.
It's making the Memphis mechanism of action and how may be differentiated from standard of care.
I'm just curious.
To hear what the reception of this candidate and approaches and the data presented to date.
And so once you go ahead.
Yeah, So actually it's a very very positive as you may know Ray. This is aro glut, one CK com have been proposed for the treatment for years, but none of those trials have been a.
Successful. So here is alluding to are one we just mechanism of action of the drug itself is somewhat differentiated itself from the autoput hormone secreted peptide secreted block out there right.
<unk> long acting you generate IGF, one desk sustain and based on the presentation at P. S. At Endo, one representing only 210 data alone in regards to growth velocity and is very clearly showing that compared to historical data moderate idiopathic population that.
The loss is somewhat match and we look at the combined data tied to see that you know what the response look like as seem like that those that have been selected especially one 6% and three <unk>, it's pretty comparable and you can see those data in six months 12 months.
Results, but again, it's very small number but most of the physician really feel intrigued about the data that did not know that disk growth hormone secretagogue work as good great and again because it what's failed in the past not to mention that if these drugs get approved we'll be out Tonight.
<unk> for their patients.
Especially the impact of complying should be less and again, we expect that the burden of injections with the majority of those patients suffering from daily alone at the could be somewhat overcome by near therapy, but again overall, it's a very.
Very very positive they all just need to looking forward for the topline data and especially the new phase III pivotal trial in the future.
The only thing I would add to that Peter is that when we when we do these presentations that in.
And paid in March.
At Endo Circumspect, right and there are lots of good questions lots of excitement lots of people.
Wanting to talk to the.
Presenters about this product so.
One on one and then the intellectual halls, we feel a lot of excitement and a lot of interest.
Might add pizza.
We always have a booth at each one of these meetings.
Right alongside of all of the competitors in the growth hormone space.
And I am absolutely amazed at the level of interest and.
<unk>.
The number of really great questions and just overall excitement that everybody feels though the fact that there is a possibility of an oral alternative for their patients.
It's a very important and exciting space to be in right now just based on the feedback from these clinicians.
That's great to hear so.
Thank you for taking my questions and congratulations on the progress.
Alright, Thank you Pete.
Thank you I'm showing no further questions from the line. This concludes the Lou most pharma second quarter earnings call.
And have a great day.
Okay.
[music].
Okay.
[music].
Yes.
Okay.
[music].
Yes.
[music].
Okay.
Okay.
[music].
[music].
Yeah.