Lumos Pharma, Inc. (LUMO) Q2 2023 Earnings Call Transcript

Lumos Pharma, Inc. (NASDAQ:LUMO) Q2 2023 Earnings Conference Call August 9, 2023 4:30 PM ET

Company Participants

Lisa Miller – Senior Director of Investor Relations

Rick Hawkins – Chief Executive Officer and Chairman

Lori Lawley – Chief Financial Officer

John McKew – President and Chief Scientific Officer

Duke Pitukcheewanont – Senior Vice President of Global Clinical Development and Medical Affairs

Conference Call Participants

Yasmeen Rahimi – Piper Sandler

Leland Gershell – Oppenheimer

Ed White – H.C. Wainwright

Catherine Novack – Jones Trading

Pete Stavropoulos – Cantor Fitzgerald

Operator

Good afternoon, and welcome to Lumos Pharma's Q2 2023 Financial Results Conference Call. Currently, 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'll now turn the call over to Lisa Miller, Senior Director of Investor Relations.

Lisa Miller

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 question-and-answer session.

I will now turn the call over to Rick.

Rick Hawkins

Well, 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 in recent weeks before turning it over to Lori for 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 a year and a half ago from Ascendis, where he worked on their long-acting injectable growth hormone therapy or therapeutic to approval. He is also President of the 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 3 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 height velocity or AHV at six 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 3 trial. We also expect our primary outcome readout to include AHV data at 12 months on treatment for up to 12 subjects per OraGrowtH210 cohort and up to 7 subjects per 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 2 trial should demonstrate a safety profile comparable to the daily growth hormone control arm. And also as is the case for all Phase 2 trials, the OraGrowtH210 trial is not powered to show non-inferiority of annualized height velocity between LUM-201 and the control arm, but should inform the design of and dose selection for successful registration Phase 3 trial.

And as a reminder, the non-inferiority margin between the treatment arm and the control growth hormone arm for a pivotal Phase 3 trial. And 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 3 trial. And after a thorough review of the data package, the first step will be to request an end of Phase 2 meeting with the FDA to review the Phase 2 results and agree upon the ultimate design of the Phase 3 trial.

And based on regulatory precedence, we expect that this registrational trial will include approximately 180 to 200 PEM positive subjects, randomized two to one versus growth hormone with a likely dose of 1.6 mgs per 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 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 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 for 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 two trials presented at the 2023 ENDO meeting. Data from these two abstracts were presented, including new data from the OraGrowtH212 trial that showed an increase in showed an increase in IGF-1 levels on LUM-201 at six months that remained within normal range, an increase in IGF-1 SDS greater than zero, and a durable growth response after 12 months of LUM-201 administration.

This 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 3.2 mgs per kg a day dose levels in 15 subjects from the OraGrowtH212, 20 subjects from 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 per kg a day doses are comparable in the growth each stimulated. And as many of you know, these data were highlighted in a key opinion leader webinar we hosted on June the 21st, where doctors Fernando Cassorla and Michael Tansey shared their insights on the data and there were continued convictions and the potential of LUM-201 to become the first oral therapeutic to address this patient population treated solely by injectable all 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 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 was held in The Hague in the Netherlands, September 21 to September 23. This abstract by Fernando Cassorla will include a deconvolution analysis of growth hormone secretion with LUM-201 administration and the moderate PGHD population.

Turning to other developments. We continue to support our clinical collaboration with Dr. Laura Dichtel in Massachusetts General Hospital to explore the potential of orally administered LUM-201 and non-alcoholic fatty liver disease or NAFLD. Positive results from this investigator’s prior trial evaluating injectable growth hormone and 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 buildup in the liver in obese 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 six months.

Reduction in absolute percent of 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. The 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 done a lot of work internally to assess the potential of LUM-201 and other indications and 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?

Lori Lawley

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 $10.5 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 from the date of the filing of our second quarter 2023 financial statement, which is well beyond our announcement of top line Phase 2 trial results in the fourth quarter of 2023. This guidance is inclusive of estimated costs to be incurred in preparation for a Phase 3 trial, 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 for regulatory agencies.

Research and development expenses increased by $1.4 million for the three 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 three 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.

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 for us.

Rick Hawkins

All right. Thank you, Lori. So to recap, we can confirm our plan to report top line data from both OraGrowtH210 and OraGrowtH 212 trials 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 OraGrowtH trials should achieve the predicted annualized high velocity at six 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 2 trials are not powered to show non-inferiority primary outcome data from these trials should support selection of LUM-201 dose for a registrational Phase 3 trial, or non-inferiority to growth hormone of approximately 1.8 to two centimeters should determine success based on historical approvals. Our novel formulation of OraGrowtH 201 should also facilitate adherence and treatment protocols in both this pivotal trial and in the commercial setting.

And if a new patent is granted, we’ll 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’ll continue to explore utility and broader indications such as NAFLD, 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 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 Webinar [ph] where noted pediatric endocrinologist will discuss their experience with PGHD patients, that 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.

Question-and-Answer Session

Operator

Thank you. The lines are now open for questions. [Operator Instructions] Our first question is from Yasmeen Rahimi of Piper Sandler. Your line is now live.

Yasmeen Rahimi

Good afternoon team. Thank you so much for all the updates. I guess could you maybe comment on how soon post the OraGrowtH readout you could be in a position to kick off the Phase 3 studies. Maybe also some color on if you've started warehousing patients for the Phase 3 and help us around enrollment timelines. And then third when do you hope to get color in regards to patents – the patents that are filed with the new formulation? Appreciate the color on those topics. Thank you again.

Rick Hawkins

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

John McKew

So, Yas, 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 2 meeting, an agreement with the FDA on our Phase 3 protocol, right? So there is a lot of work involved there and integrating the data from these two studies, making any necessary adjustments to our Phase 3 clinical plans, putting together a briefing book, waiting for 60 days to get the meeting. And then hopefully quickly come into agreement with FDA on what that Phase 3 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 3 type work 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 and I – getting – 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'd want to hold off on. In terms of the patent, so we filed this patent in November of last year, right? So, a 12 month decision time is not – it's kind of an expected times of timeline for when we might hear back on that patent.

Rick Hawkins

And, yes, let me just add. We have an – obviously a really experienced clinical development team. We've really performed well in this the 210 and 212 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 has really managed 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 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 that 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 3 in competition with each other. They're finished with those studies. They're either, obviously those products were approved. While we certainly expect there's going to be some competition for these patients, we believe this is going to be a lot less than there was before. And therefore, we think enrollment is going to well. But I – maybe I just ask Duke to comment here because he's really been instrumental in his connection with all these highly experienced sites.

Duke Pitukcheewanont

Thank you, Rick. So let me touch base with timeline enrollment, which is, again, most of the Phase 3 trial. That's one of the big hurdles that most companies have experienced, right? With my connection with the KOL around the world with experience I have done in the past, we hope that if we actually have well prepared site initiation and potentially could start up site enrollment across the world as pretty much at the same timeline, we'll be able to cut down the number of recruitment and timeline and complete enrollment. But again a lot of factors involved, but we would do our best based on strategic planning, as John had mentioned.

Yasmeen Rahimi

Got it. Thank you…

Rick Hawkins

Yas, does that answers your questions?

Yasmeen Rahimi

Yes. That was very helpful. Thank you team.

Rick Hawkins

Thank you, Yas.

Operator

Thank you. One moment, please for the next question. Our next question is from Leland Gershell of Oppenheimer. Your line is now live.

Leland Gershell

Hi, guys. Thanks for taking my question and for the comprehensive framing of how to think about things as we head into the readout later this year. Couple questions from me. First with respect to – obviously we're – 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 ESPE conference you mentioned there'd be some additional analyses of the prior study. Just wondering if you could share what the nature of those additional analysis might be. Thank you.

Rick Hawkins

All right. John, do you want to start with the PEM and the ESPE analysis?

John McKew

Sure. Thanks for the question, Leland. So, the PEM test has been very effective in – as an inclusion criteria in the 210 study. We've spent a lot of time educating the clinicians in that study as to which subjects to screen to bring into the trial. And our success rate at inclusion is actually quite high, right? We've got – we had originally said in the entire population about two thirds 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 who kind of fit 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 that the whole spread of growth hormone deficiency. The second question about the endo – or I'm sorry, the ESPE 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 that is there. Those abstracts hadn'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 about what's going to be released there. But that from the title, that should give you a good sense of what's in there.

Leland Gershell

Great. Thanks. Thanks so much for taking the questions, and I look forward to the updates.

Rick Hawkins

Thanks for the question, Leland.

Operator

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.

Ed White

Hi, thanks for taking my questions. Just going back to the Phase 3 study and this might be difficult to answer, but how are you thinking about the number of sites that you are going to need for the Phase 3 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.?

Rick Hawkins

John, you want to start?

John McKew

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 the numbers 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 – have to be, or what number of patients have 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.

Rick Hawkins

Yes, let me just continue with that. And the benefit of being on the podium at all of these endocrine 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 have 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.

Ed White

Okay, thanks Rick. 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 1 study concurrently with a Phase 3 study that we've just been discussing, or will this be something that you are thinking about post Phase 3 data?

Rick Hawkins

Ed I think that the answer to that question is if we were a large company, we would probably have a different plan. The capital markets are what they are. As we go out and do all the advanced planning for our Phase 3, 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, then we're going to start 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 at the end of Phase 2, into Phase 3, regional partners show up, or at least that's what – or partners of all the. 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 discussions to look at some partners who 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.

Ed White

Great. Thanks Rick. 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 one-time event, and we should be thinking about the run rate more like the first quarter.

Lori Lawley

I think our research and development expenses for Q2 are pretty on par with what we should expect Leland [ph] 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 3 clinical trial. So R&D, we expect overall R&D and G&A operating expenses to be between [Technical Difficulty].

Ed White

Okay. Thanks, Lori. Thank you everyone for taking my questions.

Rick Hawkins

Thank you, Ed.

Operator

One moment please for our next question. Our next question is from Catherine Novack of Jones Trading. Your line is now live.

Catherine Novack

Hi. Good afternoon, everyone. Just a question on some KOL issues. What we’ve heard time and again is that their real focus in PGHD is 12 months, 24 months and beyond. And we – 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 us 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 2 and Phase 3?

Rick Hawkins

Yes, well, thanks for that excellent question, Catherine and John will you answer that?

John McKew

Sure. So two things to keep in mind. The Phase 3 study will be a 12-month study. And so kind of the key decision point for that Phase 3 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 3 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 actings have brought in.

That said, you can look at the difference in growth or 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 well documented, that growth hormone has its kind of biggest peak in the three to six 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 that you can elevate IGF-1 and growth hormone levels out to 24 months, right? So in adults that change 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 a handful of kids past 12 months, will really start to help put those pieces together for us. But there’s certainly scenarios where you could expect that we’re going to modulate kids to a more natural growth pattern 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.

Catherine Novack

Got it. Yes, of course. And then just one more, now that we’ve got a couple 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?

Rick Hawkins

Catherine, that you look, there’s no question that this going to be a highly competitive space. And you look at the price on a monthly basis between the three growth hormone, long acting growth hormones or something like $7,000, $8,000, and $9,000 per month, all with to yearly 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 that daily because the restriction in price or longer time to approvals and in different markets around the world. We believe, I mean, we’ve done our market research. We’ve asked the question of both to ped endos and to parents if you had a choice between a weekly injection or a daily oral, they overwhelmingly say they would choose a daily oral. And on top of that, I’ll remind you, we’re a small molecule or cost of goods and our flexibility and pricing and margins is, it looks very favorable to us long term in this market.

John McKew

Well, Catherine, may I add, was the feedback from the KOL in that regard? Rick mentioned about the pricing. That’s a very important, right. Is more expensive than daily. The other issue that the KOL [ph] have some skeptical is a safety data profile. As 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 effect, which is again it’s very unclear at the short term, right? When you look at profile the growth hormone exposure for weekly growth hormone, it’s much higher than daily growth hormone and also higher IGF-1. With that said, long term post Phase 4 study or postmarking study need to continue in order to show off the safety profile in the long-term fashion. So that’s something that some KOLs still quite skeptical to really put all subject in weekly [indiscernible] therapy in regards to efficacy itself, right? So not to mention it’s very expensive.

Rick Hawkins

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

Catherine Novack

Okay. That’s answered my question. Thanks very much.

Rick Hawkins

Thanks.

Operator

One moment please for our next question. Our next question is from Pete Stavropoulos of Cantor Fitzgerald. Your line is now live.

Pete Stavropoulos

Hi, Rick and team. Nice to see all the progress made this quarter and movement towards data readout by year end. Question – first question is, when you look at the data that you’ve generated to date, using the PEM, the predictive enrich 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 the cutoffs 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 lab algorithm sufficient?

Rick Hawkins

Okay. Pete, thank you for that good question. And John I'm going to let you start.

John McKew

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, right? So we need to look at the AHV 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 now?

Pete Stavropoulos

Okay. And as you think about a Phase 3 design, I understand that you need to end of Phase 2 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?

Rick Hawkins

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

John McKew

No, I think the Phase 3 design and basic kind of inclusion characteristics are pretty common across all the three 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, that the timeline and the approximate ends, I think are pretty, 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 come before us here.

Pete Stavropoulos

Okay. And sorry go ahead. Do you have a something to add?

Rick Hawkins

No, go ahead. Please go ahead.

Pete Stavropoulos

And last question directed towards Duke, but 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 approach is and the data presented today?

Rick Hawkins

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

Duke Pitukcheewanont

Yes, so actually it’s a very, very positive, as you may know, right? This is oral growth, hormone secretagogue 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 action of the drug itself is somewhat differentiate in itself from the oral growth hormone secreting peptide or secreting secretagogue out there, right? They have long acting, you generate IGF-1 that’s sustain. And based on the presentation at PS 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 velocity somewhat match. And we look at the combined data, try to see that what the response look like. It seemed like the dose that have been selected, especially 1.6 and 3.2 is pretty comparable, and you can see those data in six month and 12 month result.

But again, it’s very small number, but most of physician really feel intrigued about the data. They did not know that this growth hormone, oral secretagogues 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 of injection with the majority of those patients suffering from daily long acting could be somewhat overcome by this new therapy. But again, overall it’s very, very positive. They all just need to looking forward for the top line data and especially the new Phase 3 pivotal trial in the future.

John McKew

The only thing I would add to that, Pete, is that, when we do these presentations at in-pay in March, PES and at ENDO [indiscernible], 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 in the lecture halls, we feel a lot of excitement and a lot of interest.

Rick Hawkins

Yes. Yes. And I might add, Pete, that we always have a bullish 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.

Pete Stavropoulos

That’s great to hear. So thank you for taking our questions and congratulations on the progress.

Rick Hawkins

All right. Thank you, Pete.

Operator

Thank you. 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.