Q2 2021 Lumos Pharma Inc Earnings Call

August 5, 2021

[music].

Okay.

Good afternoon, ladies and gentlemen, and welcome to Venus Pharma second quarter 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 day conference call is being recorded I will now turn the call over to Lisa.

<unk> senior director of Investor Relations Ma'am. Please go ahead.

Thank you before we proceed with the call I would like to remind everyone that certain statements made during this call are forward looking statements under U S Federal Securities law.

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 here.

And the company undertakes no obligation to update or revise these forward looking statements information presented on this call is contained in the press release, we issued this morning, which may be accessed from the investors page of the company's website. Joining me on today's call are Rick Hawkins, CEO, and chairman, John Mchugh, President and Chief.

Typically officer, Dr. David Karp, Lucy Lu Chief Medical Officer, and Lori Lolly, Chief Financial Officer, and corporate controller.

Following managements prepared remarks, we will open the call to your questions I will now turn the call over to Rick.

Thank you Lisa and good morning, everyone and thank you for joining us on today's call.

This morning, we issued a press release detailing our results for the second quarter 2021.

For the home call on July 21st to provide updated guidance on our clinical programs I will keep my remarks brief before turning over the call to my colleagues for additional updates on our clinical trials and our financial results.

We will open the call for your questions.

I'll begin with the recent steps we've taken to enhance our advisory board and strengthened our management team.

Last week.

We were pleased to announce the appointment of Dr. Mark Balk to our clinical and scientific advisory board or CSB.

Dr. Bob joins our distinguished panel comprised as noted pediatric endocrinologist, Dr. Peter Clayton Rico here kawa towards Werther, and CSA be chairman Dr. Ron Rosenfeld.

Okay.

<unk> block is currently Chief Medical officers Officer for show T. And previously was senior Vice President Endocrine Medical Sciences at ascend this pharma here.

He is a pediatric endocrinologists with 30 years of clinical research and pharmaceutical development experience, including extensive global experience building and leading clinical team that has successfully launched innovative pharmaceutical products and to worldwide markets.

Prior to the ascend this Dr box for 9 years at Janssen, a subsidiary of Johnson <unk> Johnson, concluding this time, there is head of Asia Pacific Medical Sciences, and head of China, R&D and prior to Janssen, Dr Block held positions of increasing responsibility in clinical research at Merck and company.

And in his tenure there as vice President of clinical research operations worldwide.

Now early in his career, Dr. Cobalt conducted extensive clinical and preclinical research on growth hormone.

<unk>, 1 and <unk> 201, formerly known as MK 677 with data from his work published in scientific and medical journals.

He brings to our advisory board, a wealth of knowledge and experience with growth hormone related disorders, and a significant understanding of the unique advantages of lunar 201 could offer to the growth hormone deficient populations.

We are obviously thrilled to have him join our esteemed advisory board and look forward to his contributions to Illumina pharma clinical and commercial strategy.

And earlier this week, we also announced the promotion of my respected colleague and friend John Mchugh to the position of president of low most pharma.

John has served as our chief operating officer.

April 2020, and our Chief Scientific Officer.

Since he joined luminous pharma in 2016.

John has nearly 30 years of experience.

Net developing novel Therapeutics, primarily for rare diseases, and as except successfully advanced multiple therapies through preclinical and clinical development.

And prior to joining Lou most pharma he served as vice President of research at HR Pharma, we let our research team discovering and advancing protein based therapeutics for rare diseases.

He has also served as acting scientific director for the National Center for advancing translational science or in cats and from real group a part of the National Institute of Health.

In cash as labs work on rare and neglected tropical diseases and public private partnership led to the collaborative advancement of several therapeutic candidates currently being commercialized by pharmaceutical companies.

John promotion to President of <unk> pharma is in recognition of this vital contributions and advance the link to zero 1 for the treatment of P. Ghd as part of the succession planning conducted by the company and our board of directors.

John has extensive clinical and management experience at the NIH and the pharmaceutical industry, including his contributions during his tenure at <unk> pharma position him well for served in this new role.

And on Tuesday, we announced the expansion of our management team with the addition of Dr. David Karp as our new Chief Medical Officer.

David is an endocrinologist and academic and accomplished biopharm pharmaceutical executive and is currently an adjunct clinical professor in the division of Endocrinology at Stanford University School of Medicine.

David has 35 years of experience in the field of endocrinology and as a Biopharma executive. He has 30 years of experience in all facets of biopharmaceutical clinical development from preclinical to phase for regulatory interactions with both the FDA and international agencies and marketing and launch activities.

<unk>.

Most recently he was vice President clinical development.

And clinical operations for ascend is pharma.

Where he was responsible for several compounds in clinical development, including Transcon GH long acting growth hormone for once weekly treatment of growth hormone deficiency.

He previously served as Chief Medical Officer for several biotechnology companies and he has also held leadership positions in clinical research and endocrinology at both Roche and previously at Merck, where he gained familiarity with our therapeutic candidate loom to zero 1.

And we look forward to David's guidance and assistance in advancing low to zero 1 towards commercial approval. So welcome David.

Thank you Rick for your kind introduction and good afternoon, everyone.

I wanted to add how excited I am to join the <unk> team.

As Rick mentioned I'm very familiar with loomed tool 1 assets from my time at Merck.

Based on my experience treating quite so much efficiency in my experience developing a long acting growth hormone for patients with ghd.

I believe that loomed 201, as an oral therapy.

Essentially a breakthrough advance in this therapeutic area.

Lewis has a well developed clinical plan to advance this assets and I look forward to working with Rick John and the rest of the team to execute on our clinical strategy.

Thank you David and again welcome.

And before turning the call over to John for an update on our clinical programs I just want to highlight common theme and vs appointment.

And that is the view held by many experts in endocrinology at the potential of lunar 201 to be a breakthrough oral therapy for the treatment of PGP.

On the strength of that potential we believe Loomis has put in place the talent and expertise needed to advance this asset and realize its full commercial expectations.

So with that I'll turn the call over to John.

Thank you Rick and welcome David We're all looking forward to working with you.

As Rick mentioned earlier, we provided updated guidance on our clinical programs on our call on July 21.

As a reminder for 6 month primary outcome data readout for our oil growth 210 trial is now anticipated in the second half of 2023.

The extension was prompted.

Bye and initially slower pace of site initiation doing due to ongoing COVID-19 restrictions on certain international sites and the disruption of the typical referral patterns for this patient population.

We further expect referral patterns to normalize as children return to school and communities adapt to the persistent presence of COVID-19.

As we continue to open new clinical trial sites for this trial, we are beginning to see the pace of screening and enrollment increase as compared to the first half of this year.

Separately, we also announced the extension of the protocol for the oil growth 210 trial for an additional 6 months on therapy in response to the Fda's request for 12 months data prior to the initiation of our previously planned 3 year long term extension study the order growth to 11 trial.

Again, the primary outcome data readout of the order growth to 10 trial remains at 6 months on therapy.

This order growth to 10 protocol extension mirrors the previous plan for this first 6 months of the order growth to 11 long term extension study.

We believe the extension of this trial will provide a more robust data package for future regulatory filings.

Zero growth to 11 trial was proposed to capture long term treatment effects for patients who responded to link to a 1 on previous trials. However that study was not on a critical path for the initiation.

For the phase III trial.

We announced the initiation of our oral growth to 12 trial in Q2, we subsequently announced the proposed extension of the treatment period of this trial from 6 months to 12 months for.

Growth to 12 is a small single site open label trials to illustrate the pharmacokinetic and pharmacodynamic effects of Luke tier, 1 and PTH D and replicate the possibility data that currently exists for a link to 1 in adults and in a small subset of children from the phase 2 O to O trial.

We also decided to extend this trial to capture additional PK PD and height velocity data.

The PD pulse utility assessment will continue to be assessed at 6 months on therapy.

Trial was initiated in June and is currently enrolling patients.

To recap both the order growth to 10, and our growth to 12 trials will provide data readouts at 6 months on therapy as was originally planned.

The extensions to 12 months on therapy will enhance the supporting data package for our overall link to a 1 program.

Furthermore, we do not anticipate these protocol changes on a standalone basis to extend our clinical development timeline.

With that I will turn the call over to Lori who is joining us for the first time on her new role as CFO for a review of our second quarter financial results Laurie.

Thanks, John and good afternoon, everyone. We ended the second quarter on June 30th 'twenty, 'twenty, 1 with cash and cash equivalents totaling 100 point $107.7 million compared to $98.7 million on December 31st 2020 cash on hand as of the end of Q2, 'twenty or 'twenty 1 is expected.

To support operations.

6 month data readout from both the oral growth to turn and Ora growth to 12 trials.

Research and development expenses for the second quarter at $4.1 million.

An increase of $1.4 million over the same period in 2020. The change is primarily due to an increase of $1.8 million in clinical trial and contract manufacturing expenses.

All set by a decrease of $4 million in personnel on operational expenses.

Our general and administrative expenses for the second quarter or for $6 million, an increase on <unk> 4 million compared to the same period. In 2020. This increase is due to an increase of $1.1 million in personnel related expenses, primarily due to the recording of severance expenses for our former CFO offset by decreases in Lee.

Both consulting and operational spend of <unk> 7 million and.

The net loss for the second quarter was $8.7 million compared to a net loss of $5.4 million for the same period in 2020.

We ended Q2, 2020, 1 with 8 million 357391 shares outstanding.

And with that I will turn it back for Rex for closing remarks.

Thank you Laurie so before taking your questions I just wanted to say we have advanced our discussions with key opinion leaders and our clinical scientific advisory board to expand our lunar 201 platform.

We're actively reviewing the pathway for Luna to zero or 1 and a certain subset of affected patients and other potential indications, including Turner syndrome, <unk> Willi syndrome, idiopathic short stature and for children born small for gestational age.

We're confident in our belief that link to zero 1 represents a pipeline in a product and look forward to advancing the next phase of the low to zero 1 line lifecycle.

And we'll provide further updates when we are ready to discuss comprehensive clinical plans. In addition, we continue to evaluate select rare disease assets under consideration to add to our product portfolio.

As I stated before we are being highly selective and judicious in our process and we will focus on our decisions on what provides the best long term value creation for our shareholders.

The enhancement of Lewis pharma leadership team and encouraging recent trends and screening and enrollment for both order growth to turn and Ora growth through to acquire trials are positive developments for the company.

John David and Mark each bring significant clinical development and management expertise to their new roles with the company and strengthen our ability to execute on our clinical and corporate strategy.

We believe that as schools reopen in pediatrician visits resume we should see increased referrals and accelerated enrollment in our trials for this fall.

With that operator, we're now ready to take questions.

Ladies and gentlemen, if you have a question at this time simply press. The Star then the number 1 on your telephone keypad. If your question has been answered or you wish to remove yourself from the queue. Please press the guarantee against these from the Star line to ask a question going on and please for our first question.

Your first question comes from the line of Yasmin Rahimi of Piper Sandler Your line is open.

Hey, this is for Luisa answer yes. Thank you so much for taking my questions. So we have 2 for you. This morning, Barry do.

Do you guys think that you'll be opening additional sites to maintain enrollment timelines.

Yes, or no could you. Please just provide a little bit of color on that.

And next we were wondering at your current cash balance is sufficient to build up your pipeline also getting to the finish line for autographs too tiny to keep trial studies.

And should we be expecting pipeline expansion Atlanta Chiller line in 2021 of 2022.

Ken.

The first question.

I believe we've anticipated for quite some time.

The concern over COVID-19, so we did a site.

Spansion to about 52 sites quite some time ago and on.

And as I mentioned earlier the majority of the sites are open.

And we are rapidly advancing and trying to open the rest of those sites. So.

And also I think there's a very broad geographic distribution. So once again, I think thats going to help us to but but beyond to about $50 or 52 sites. We have planned right now.

I think that's going to be sufficient to meet our enrollment.

In terms of cash.

On a very strong position and as Lori said, we can get a readout on our 210 and $2.12 studies.

It also means we are going to have to be that much more judicious in our review of anything that we want to bring into the company.

This may.

Open up us to looking at assets that are more in the preclinical or provide us with close to the clinic.

But at the same time want to emphasize.

We have a robust process in place and we're being very careful and judicious in our review of anything that we want to bring in as an asset.

Thank you.

Yes.

Your next question comes from the line of Charles Duncan of Cantor Fitzgerald. Your line is open.

Yes.

Yes, good morning, Thanks, Rick and team.

For the update as well as taking my call. Congrats on all the new Joiners. If you will on the management team I had a couple of questions first of all perhaps for John in terms of low or the 210 study I guess I'm wondering if you could remind us of the screen.

<unk> vs enrollment rates that youre looking for the screen failure rates given the Pam.

And it seems like.

Just maybe help me understand the second half of 'twenty 3 data.

So it seems like a year and a half to enroll. This study is long so is it perhaps debt youre being overly conservative.

John go ahead.

So that we.

We can talk first about the screen.

Failure rate, so our our assessment of the screen failure rate or the debt.

Percentage of patients with a P. Ghd diagnosis SKU RPM positive, which I think is the important part here.

As we published recently on the journal of Endocrine Science, we did an analysis of <unk>.

Large 20 year long multinational phase 4 study called.

Called the Genesis dataset, which is based on beliefs experience with their were commenting on the growth from a product.

And we were able to apply.

Our our.

<unk> P M cutoffs for that dataset and generate a much broader.

And a large data set a very nice assessment that about 60% of the patients would be <unk> positive.

I would say, we're working on a much smaller scale than than that data set as we do screens for our study.

So we don't we don't expect to have data that.

That is going to be as telling as the.

Genesis dataset. So I think that's that's the screen failures that.

And then for the second for.

For the re guiding really it isn't about screen failures, it really isn't about.

Anything other than.

Just a slow.

On a slow recruitment.

That is based primarily on a slow process, that's based primarily on <unk>.

Delays that were.

Primarily attributed to COVID-19, I would say that I think we are being conservative we want it.

<unk> be the market on.

Our timeline.

Pace of patient recruitment that we think is achievable and we will work very hard to not only achieve that but to all weekend to 2 people.

Okay and channel.

Hi, Mike.

Go ahead.

I might add I mean, there's no question.

There is there is a concern on everybody's mind.

The COVID-19, and its current status.

We want to be conservative in our <unk>.

Prediction at this stage.

But are certainly we certainly believe that debt with the number of new screen patients.

It's encouraging.

Okay.

And then if I, if I may and I apologize upfront, but Patrick Carphone going to put you on the spot and that is yes.

Basically a question of.

Why why join Lu Moe and really what I'm interested in I'm, particularly intrigued.

With the C secretagogue and pulsatile release of growth hormone and how that may be different than say, a simple simple replacement therapy.

And I'm not being dismissive of the convenience and compliance benefit, but I'm just kind of wondering mechanistically. If you could provide your thoughts on on those those different mechanism.

Well I I could not agree with you more actually so what I have been attracted to with the molecule <unk> 677 is precisely that.

Talk about a physiological replacements.

It's been known for a long time debt once weekly once daily neither 1 of those modalities actually recapitulates the normal.

On line access.

Which is which is basically a very low base hold with spurts of growth hormone mostly at night.

Non peaks.

And.

Yeah.

I was struck when I was at Merck with.

I mean, he was he was an oral agent you can take more need to take in the evening and what it did was simply enhance the normal growth hormone peaks I mean talking on.

On a marvelous design of a drug.

Now when I was at Merck Merck was all about large population, where the antithesis of a company that was interest.

Our orphan indication.

So.

This was a beautifully designed drug and they wanted to try to share.

Search out a big population and they chose Shakopee union, the elderly, which unfortunately locked in I think continues to lack a registration endpoint.

So that was their intent I think to make a large market like.

Hypertension, hyperlipidemia osteoporosis out of them.

Out of this molecule, but they had enough faith in this as they did to license it to a colleague of mine like a foreigner for redevelopment and.

And Phd and.

I'm very excited about this now I'm on.

Bullish about transcon growth hormone.

Little bit less bullish on freedom of religion about on pathogen, but.

What I see I mean, when I retired from.

And then just last September I was very happy seeing my 600 patients at Stanford and doing some consulting.

And I really did not have any intentions at that time of getting back into a full time position for when Rick called me and I realize what this molecule was.

I mean I.

What excites me is that I've been able so far to bring 3 effective.

Can you really 300 potential NDA and brought to effective drugs to patients in very soon a third drug to patients for unmet medical need and I view this opportunity with Lou most as my last.

A great chance of bringing a really effective drug to a significant unmet need in patients.

Think that for.

For the appropriate patients this will be a very very good treatment of their.

Of course from a deficiency.

Did I answer your question.

Yes, absolutely and really appreciate all the color I am looking forward to seeing it move forward as well.

Last question is for for Rick perhaps on strategy.

I guess, you mentioned the pipeline and it would seem to me that you have your kind of your hands full with lunar 201, and it's a promising candidate and I guess I'm wondering.

How do you look at it in terms of being a pipeline in a product with other indications relative to <unk>.

In licensing opportunities it would seem to me that the capital markets have kind of competed against you with regard to latter aspect of debt or route in terms of that strategy and Im wondering if theres a fabry, leading additional indications that you would want to highlight for Luna to them on.

It's a good question Chaz.

When I say that.

First and foremost our priority remains to stay focused on executing on our on our.

For growth to 10 study and 212 study plan.

I think that also evaluating other indications.

All of our compound because of its unique mechanism of action would likely be beneficial and provide.

And we're going to provide updates on a on a.

At the appropriate time, when those plans are more fully cooked.

But.

Obviously this unique opportunity with this compound and because we are and we are engaging all of the important kols out there.

As we lay out our plans youll be the first to know.

I think it's prudent for us, though to continue based on our extensive backgrounds in the rare disease space.

Continue to look for opportunities or there are other assets out there now.

No we've been doing this for quite some time and we havent pulled the trigger on anything and Thats because.

We have been as as careful and judicious as we possibly can because anything that we do.

We want to make sure that this a strong value proposition for our shareholders and thats all the risk to it.

But I think it would be imprudent for us not to have a process in place.

To find a unique assets just like the unique assets that we're developing and link to zero 1.

Very good thanks for taking my question and appreciate the update.

Okay.

Your next question comes from the line of Ed White of H C. Wainwright. Your line is open.

Good morning, Thanks for taking my questions. So maybe start with a question for Laurie.

Curious as to.

R&D spend going forward.

We would expect to see the trend going up as their trials for initiated.

Sequentially R&D expenses were down I'm, just wondering if you can give us some.

Thoughts on how we should be thinking about the next 2 quarters for R&D expense.

Sure and thank you for the question and so sequentially compared to Q1, we had some severance cost that were recorded in Q1 for the departure of our former CMO of approximately $1.4 million.

Would expect and anticipate that our Q2 spend is reflective of what we will expect going forward with increases as we advance our clinical trials and path for in towards a register towards the phase III trial.

Great. Thank you.

You're quite right solutions okay.

John Congratulations on the.

On your new role.

Entitle I'm just wondering how your your role is changing within the company. If you can give us any any thoughts to that.

Okay.

Well. Thank you for you for the congratulations Ed and really I think.

The focus will will continue to be similar to the role I have been saying I think it's.

Sure.

A promotion, where I'll be able to focus on on both the operational on scientific aspects of the company and making sure that we deliver on all the aspects of our guidance.

Okay and.

And maybe just the last question I have we have been talking about enrollment.

In the 210 study.

I'm just curious on 2 things now that we're seeing you had mentioned debt.

As.

Children go back to school, there could be perhaps more.

For the attrition visits.

Could see more interest in the studies I'm, just wondering how you're thinking about.

The Delta variant and.

What is that going into your thought process on <unk>.

Enrollment trends and then when could we see.

Youll give us an update on what the actual enrollment are in these 2 studies will you be telling us when you get halfway there or maybe perhaps over the next few quarters do you plan on giving us updates on how the enrollment is going thank you.

Yes, I'll start with that.

Ed.

We haven't.

Any timing guidance that we're going to address 1 where.

A quarter or a half for or 3 quarters away true.

We're just we just have our noses to the grindstone trying to make sure that we're doing everything we can.

To make sure the study goes as well as possible.

Perhaps we would.

<unk> the market.

<unk>.

More appropriate time, but right now for a little bit too early on.

And John could you take his first question regarding the Delta virus impact.

Yeah. So I think the Delta variant, it's much like the Alpha variant was last year right. So the way we plan around that is.

Right now as Rick has mentioned, we have more than 50% of our sites up and running part of our delay in the past was as much about getting sites up through delays of getting through <unk> and interacting with.

Lawyers and contract people at clinical sites, who are working from home, which seem to add an enormous amount of time.

And I think we have those sites up and running and as we had mentioned in the past we have.

Sites spread across various geographies in the U S. But also internationally in eastern Europe and then.

And in Australia, and New Zealand and I think the combination of those 2 things are really going to help us.

Kind of juggle loop from area to area, where.

No.

The pandemic waxes and wanes.

But I also think regardless that at this point.

Communities are starting to learn how to live with COVID-19 debt I don't.

It's hard to imagine that we would go through another school year with the with remote learning for the entire year I think we will find ways to be successful in educating kids.

Yes, which will which will stimulate trips to the pediatrician and referrals for the pediatric endocrinologists.

If I could just endures for John just said.

It absolutely mirrors my experience getting the true.

First on PTH.

Ah studies enrolled under Covid, which is exactly what he said the delay is getting sites initiated.

Even the initial.

Epidemic did.

Did not have a meaningful impact because.

But once you indicated diagnosed I mean, the parents really want this kid treated.

So there was really minimal impact and is subject coming into the site all of the delay was really getting the site initiated in all the hoops you've got to go through to get a site initiated so I just wanted to endorse for John said about that and I expect that to happen.

A link to a 1 trial as well.

Yes.

Great. Thanks for taking my questions.

Thank you Ed.

Your next question comes from the line of <unk> Yang of Jefferies. Your line is open.

Hi, Good morning. Thanks for taking my question. This is <unk>, calling in for you. So for Dr. Couch. How quick 1 question. So do you think that before starting phase 3 the regulatory agencies might act asked for additional study where you'd have to compare the efficacy of them to our line in <unk>.

<unk> positive versus negative to our share with that.

And then from a line has selected advantageous activity in the positive population. Thank you.

No.

I'll tell you that since.

Dr. Kerr from just arrived I think led.

Let John start with that question and perhaps.

Yes, I am comfortable making a stab at that but go ahead, yes.

Yeah, So I think.

We have previous <unk>.

Dataset that we've analyzed and we've separated out PM positive and negative, but theres a dramatic difference and obviously, we published on that.

So I do think actually that the.

The PM positive data.

Prospectively selecting those patients had bringing them into our ongoing trial is really going to be the proof.

That the FDA and I think of the market.

We will appreciate as well to show that this this enrichment strategy really does work effectively and remember this enrichment strategy is based on physiology right. So the kids who are <unk> negative.

Simply.

Don't have an active assets they don't have enough Savannah tropes, they can't store growth or were on theyre not going to be able to respond to our drug which is just going to.

Stimulate the release of endogenous growth hormone.

So it seems mathematical when you look at how we generated that data, but it is tied to physiology and I think we can make that case very effectively to regulators as well.

In a scientific setting to show that.

As long as we can show the PM positive kids are growing and we're able to enrich that population of responders with our cutoff I think I think that will be sufficient evidence.

And David do you want to add anything yeah, I'll, just say that on the 1 hand. This is my second day at the company.

On the other hand based upon my 30 years of experience dealing with endocrine metabolic group I.

Can say with I think somebody authority of the following first of all I think the agencies like third party payers are would be absolutely thrilled at the selection process to identify the best patients for the drug I think that the phase III trial, if I had to guesstimate for basically.

About a 2 to 1 randomization between <unk> selected patients for the link to our loan group versus unselected patients for daily growth hormone and it would be a 12 month study and the likelihood of having to go for PM positive versus being negative I would handicap as as close to zero has to be.

Negligible.

This is there's just no there's no rationale for that.

I would be willing to bet a lot of money it'll BP on selected vs. Unselected for daily growth hormone that'll be the phase III study.

We shall see.

Great. Thank you.

Yes.

Your last question comes from the line of Catherine Nowak with Jones trading your line is open.

Hi, Thanks, very much for taking my questions I had a couple on pipeline expansion possibilities.

First as you think about potential BD opportunities what are some specifications that you're looking at in terms of assets that you think makes sense in your portfolio.

Catherine Thanks for your question our criteria is really always included.

With a good strategic fit.

Strong scientific rationale and really strong value proposition for our shareholders.

We have been willing to look at the earlier stage opportunities and going to continue to do so on a very selective basis.

But.

And above all we'd like to stay on the endocrine space I mean.

We have a lot of experience in.

Especially with.

David arriving I think the opportunities will are going to expand for us to look at.

And our process I think is a very good 1 but.

As you know, we havent pulled the trigger on anything because.

Yes.

It Hasnt met are really careful and judicious.

Criteria.

Yeah.

Thanks that makes sense and then.

When you're thinking about expanding link to our Hawaiian into these other indications where growth hormone is a true do you have an idea of what subset of patients might benefit from the 201 unique mechanism of action.

And John why don't you start with that.

Okay.

So.

The only.

Growth from a deficiency population that link to 1 thats been tested in right now is in the.

Just on the PGA HD population right. So that's the population where we have a correlation there perm tests.

Back to growth rates from the outcome.

So each of the other indications that growth umbrella is approved then has.

Unique assets to do the etiology of the disease right. Sometimes there are things there is some growth on the deficiency and there are some downstream modulation of receptor activity or IGF on activity.

So that's really where we've been spending our time, that's looking looking for all those assets and trying to understand really the overall potential of link to 1 and in that area and also thinking through how would pull <unk> effect.

Each of those individual disease states versus the bullets right. So we have good ideas of how that how that might have an impact on PTH D and we want to understand that for some of the other indications.

And then once we get past that we do try to assess how Frank is the growth on 1 deficiency itself in.

And each 1 of these indications and that's really can be an indicator.

Where our mechanism of action of stimulating the release of endogenous growth on line is going to play in each 1 of these indications and that's that's really what we're building that.

That dataset through mining.

Mining.

Information on natural history data about each 1 of these diseases right now.

To put together, our prioritized list, because where we're going to go forward.

Thank you very much.

Thank you Catherine.

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

Well, we thank you for joining us today, and we look forward to keeping everyone apprised of our program over the course of the year. Thank you very much.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

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Yes.

Okay.

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Sure.

Yes.

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Good afternoon, ladies and gentlemen, and welcome to them is far less second quarter 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 will now turn the call over.

For the cellular senior director of Investor Relations Ma'am. Please go ahead.

Thank you.

Before we proceed with the call I would like to remind everyone that certain statements made during this call are forward looking statements on the 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.

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 these forward looking statements information presented on this call is contained in the <unk>.

Yes release, we issued this morning, which may be accessed from the investors page of the company's website. Joining me on today's call are Rick Hawkins, CEO and Chairman, John Mchugh, President and Chief Scientific Officer, Dr. David Karp Limited, New Chief Medical Officer, and Lori Lolly, Chief Financial Officer and corporate.

Controller pharma.

During managements prepared remarks, we will open the call to your questions I will now turn the call over to Rick.

Thank you Lisa and good morning, everyone and thank you for joining us on today's call on.

This morning, we issued a press release detailing our results for the second quarter 2021.

Since we held our call on July 21 to provide updated guidance on our clinical programs I will keep my remarks brief before turning over the call to my colleagues for additional updates on our clinical trials and our financial results.

We will open the call for your questions.

I'll begin with the recent steps we've taken to enhance our advisory board and strengthened our management team.

Last week.

We were pleased to announce the appointment of Dr. Mark Balk to our clinical and scientific Advisory Board for CSI.

Dr. Bob joins our distinguished panel comprised of noted pediatric endocrinologist, Dr. Peter Clayton Raiko here Kawa, George Werther, and CFPB Chairman, Dr. Ron Rosenfeld.

Dr. Block is currently Chief Medical officers Officer for show and previously was senior Vice President Endocrine Medical Sciences.

On this pharma here.

He is a pediatric endocrinologist for 30 years of clinical research and pharmaceutical development experience, including extensive global experience building and leading clinical team that is.

Successfully launched innovative pharmaceutical products and true worldwide markets.

And in his tenure there as vice President of clinical research operations worldwide.

Now on early in his career, Dr. Cobalt conducted extensive clinical and preclinical research on growth hormone.

<unk>, 1 and <unk> 201, formerly known as MK 677 with data from his work public in scientific and medical journals.

We are obviously thrilled to have him join our esteemed advisory board and look forward to his contributions to Illumina pharmacy clinical and commercial strategy.

And earlier this week, we also announced the promotion of my respected colleague and friend John Mchugh to the <unk>.

On a president of <unk> pharma.

John has served as our Chief operating officer since April of 2020, and our Chief Scientific Officer.

Since he joined luminous pharma in 2016.

John has nearly 30 years of experience.

On the developing novel Therapeutics, primarily for rare diseases, and as except successfully advanced multiple therapies through preclinical and clinical development.

And prior to joining <unk> pharma. He served as vice President of research at <unk> Pharma we are.

Our research team discovering and advancing protein based therapeutics for rare diseases.

It also served as acting scientific director for the National Center for advancing translational science or in cats and from rail group a part of the National Institute of Health.

And cash is labs work on rare and neglected tropical diseases and public private partnerships led to the collaborative advancement of several therapeutic candidates currently being commercialized by pharmaceutical companies.

John promotion to President of <unk> pharma is in recognition of this vital contributions in advancing low to zero 1 for the treatment of <unk>.

As part of the succession planning conducted by the company and our board of directors.

John has extensive clinical and management experience at the NIH and the pharmaceutical industry, including his contributions during his tenure at numerous pharma position him well for served in this new role.

And on Tuesday, we announced the expansion of our management team with the addition of Dr. David Karp as our new Chief Medical Officer.

David has 35 years of experience in the field of endocrinology and as a Biopharma executive. He has 30 years of experience in all facets of biopharmaceutical clinical development from preclinical through phase for regulatory interactions with both the FDA and international agencies and marketing and launch activities.

<unk>.

Most recently he was vice President clinical development.

And clinical operations for ascend is pharma.

Where he was responsible for several compounds in clinical development, including Transcon GH long acting growth hormone for once weekly treatment of growth hormone deficiency.

And we look forward to David's guidance and assistance in advancing low to zero 1 towards commercial approval. So welcome David.

Thank you Rick for your kind introduction and good afternoon, everyone.

I wanted to add how excited I am to join the low most team.

As Rick mentioned I'm very familiar with loomed tool 1 asset from my time at Merck.

Based on my experience treating quite so much efficiency in my experience developing a long acting growth hormone for patients with ghd.

I believe that loomed 201, as an oral therapy.

Essentially a breakthrough advance in this therapeutic area.

Lewis has a well developed clinical plan to advance this assets and I look forward to working with Rick John and the rest of the team to execute on our clinical strategy.

Thank you David and again welcome.

And before turning the call over to John for an update on our clinical programs I just want to highlight common theme and disappointment and that is the view held by many experts in endocrinology at the potential of lunar 201 to be a breakthrough oral therapy for the treatment of PTSD.

On the strength of that potential we believe Loomis has put in place the talent and expertise needed to advance this asset and realize its full commercial expectations.

So with that I'll turn the call over to John.

Thank you Rick and welcome David We're all looking forward to working with you.

As Rick mentioned earlier, we provided updated guidance on our clinical programs on our call on July 21.

As a reminder for 6 month primary outcome data readout for our oil growth 210 trial is now anticipated in the second half of 2023.

The extension was prompted.

We further expect referral patterns to normalize as children return to school and communities adapt to the persistent presence on COVID-19.

As we continue to open new clinical trial sites for this trial, we are beginning to see the pace of screening and enrollment increase as compared to the first half of this year.

Again, the primary outcome data readout of the order growth 210 trial remains at 6 months on therapy.

This order growth to 10 protocol extension mirrored the previous plan for this first 6 months of the order growth to 11 long term extension study.

We believe the extension of this trial will provide a more robust data package for future regulatory filings.

Zero growth to 11 trial, what's proposed to capture long term treatment effects for patients who responded to link to a 1 on previous trials. However that study was not on a critical path for the initiation.

For the phase III trial.

We announced the initiation of our oral growth to 12 trial in Q2, we subsequently announced the proposed extension of the treatment period of this trial from 6 months to 12 months for.

For our growth to 12 is a small single site open label trial to illustrate the pharmacokinetic and pharmacodynamic effects of low tier 1 and PTH D and replicate the possibility data that currently exists for a link to 1 in adults and in a small subset of children from the phase 2 O to O trial.

We also decided to extend this trial to capture additional PK PD and height velocity data.

The PD pulp utility assessment will continue to be assessed at 6 months on therapy. The trial was initiated in June and is currently enrolling patients.

To recap both the order growth to 10, and our growth to 12 trials will provide data readouts at 6 months on therapy as was originally planned.

The extension to 12 months on therapy will enhance the supporting data package for our overall link to a 1 program.

Furthermore, we do not anticipate these protocol changes on a standalone basis to extend our clinical development timeline.

With that I will turn the call over to Lori who is joining us for the first time on her new role as CFO for a review of our second quarter financial results Laurie.

Thanks, John and good afternoon, everyone. We ended the second quarter on June 32021, with cash and cash equivalents totaling 100 point $107.7 million compared to $98.7 million on December 31st 2020 cash on hand as of the end of Q2, 'twenty or 'twenty, 1 is expected to support.

What operations to the 6 month data readout from both or a growth of 210 and for our growth to 12 trials.

Research and development expenses for the second quarter at $4.1 million.

An increase of $1.4 million over the same period in 2020. The change is primarily due to an increase of $1.8 million in clinical trial and contract manufacturing expenses.

All set by a decrease of $4 million in personnel on operational expenses.

Our general and administrative expenses for the second quarter or for $6 million, an increase of <unk> 4 million compared to the same period. In 2020. This increase is due to an increase of $1.1 million in personnel related expenses, primarily due to the recording of severance expenses for our former CFO offset by decreases in link.

Both consulting and operational spend of <unk> 7 million and.

The net loss for the second quarter was $8.7 million compared to a net loss of $5.4 million for the same period in 2020.

We ended Q2, 2020, 1 with 8 million 357391 shares outstanding.

And with that I will turn it back to Rick for closing remarks.

We're actively reviewing the pathway per room to zero or 1 and a certain subset of affected patients and other potential indications, including Turner syndrome, <unk> Willi syndrome, idiopathic short stature and for children born small for gestational age.

We're confident in our belief that link to zero 1 represents a pipeline in a product and look forward to advancing the next phase of the low to zero 1 line lifecycle.

As I stated before we're being highly selective and judicious in our process and we will focus on our decisions on what provides the best long term value creation for our shareholders.

The enhancement of Bloom Lewis pharma leadership team and encouraging recent trends and screening and enrollment for both oil growth to turn and Ora growth through to acquire trials are positive developments for the company.

We believe that as schools reopen in pediatrician visits resume we should see increased referrals and accelerated enrollment in our trials. This fall so with that operator, we're now ready to take questions.

Ladies and gentlemen, if you have a question at this time. Please press. The Star then the number 1 on your telephone keypad. If your question has been answered or you wish to remove yourself from the queue. Please press the guarantee against these prices for line to ask a question going on and please for our first question.

Yes.

Your first question comes from the line of Yadkin Brahimi of Piper Sandler Your line is open.

Hey, this is for Liza on for yes. Thank you so much for taking my questions. So we have 2 for you. This morning first.

Do you guys think that you'll be opening additional sites to maintain enrollment timelines.

Yes, or no could you. Please just provide a little bit of color on that.

And next we were wondering at your current cash balance is sufficient to build up your pipeline also getting to the finish line for autographs to tongue in cheek Swab studies.

And should we be expecting pipeline expansion Atlanta to that line in 2021 of 2022.

Yes.

Well the first question.

I believe we have anticipated for quite some time.

The concern over COVID-19, so we did a site.

Spansion to about 52 sites quite some time ago and on.

And as I mentioned earlier the majority of the sites are open.

And we are rapidly advancing and trying to open the rest of those sites. So.

And also I think there is a very broad geographic distribution. So once again, I think thats going to help us to but but beyond to about $50 or 52 sites. We have planned right now that I think that's going to be sufficient to meet our enrollment.

In terms of cash.

We're bringing on a very strong position and as Lori said, we can get a readout on our 210 and $2.12 studies.

It also means we are going to have to be that much more judicious in our review of anything that we want to bring into the company.

This may.

Often up to.

As to looking at assets that are more in the preclinical or close to the clinic.

But.

But at the same time I want to emphasize.

We have a robust process in place and we're being very careful and judicious in our review of anything that we want to bring in as an asset.

Thank you.

Yes.

Your next question comes from the line of Charles Duncan of Cantor Fitzgerald. Your line is open.

Yes.

Morning, Thanks, Rick and team.

For the update as well as taking my call. Congrats on all the new Joiners. If you will on the management team I had a couple of questions first of all perhaps for John in terms of loan or the 210 study I guess I'm wondering if you could remind us of this.

Screen versus enrollment rates that youre looking for the screen failure rates, given the Tam and it seems like and just maybe help me understand the second half of 'twenty 3 data.

It just seems like a year and a half to enroll. This study is long so is it perhaps debt youre being overly conservative.

Yes.

John go ahead.

So let.

We can talk first about the screen.

Failure rate, so our our assessment of the screen failure rate or the.

Percentage of patients with a P. Ghd diagnosis SKU RPM positive, which I think is the important part here.

As we have published recently on the journal of Endocrine Science, We did an analysis of a very large 20 year long multinational phase 4 study called.

Called the Genesis dataset, which is based on the lease experience with their were coming from a growth and on product.

And we were able to apply.

Our our.

<unk> P M cutoffs of that dataset and generate a much broader.

And a large data set a very nice assessment that about 60% of the patients would be <unk> positive.

I would say, we're working on a much smaller scale than than that data set as we do screens for our study.

So we don't we don't expect to have data that.

You know that it's going to be as telling as the.

Genesis dataset. So I think that's that's the screen failures that.

And then for the second for.

For the re guiding really it isn't about screen failures, it really isn't about.

Anything other than.

Just a slow.

On a slow recruitment.

That is based primarily on a slow process, that's based primarily on <unk>.

Delays that were.

Primarily attributed to COVID-19, I would say that I think we are being conservative we want it.

<unk> be the market on.

Our timeline.

Pace of patient recruitment that we think is achievable and we will work very hard to not only achieve that but to all we can to 2 people.

Okay and channel.

Hi, Mike.

Go ahead.

I might add I mean, there's no question.

There is there is a concern on everybody's mind.

The COVID-19, and its current status.

We want to be conservative in our <unk>.

Prediction at this stage.

But are certainly we certainly believe that debt with the number of new screen patients.

It's encouraging.

Okay.

And then if I, if I may and I apologize upfront.

Patrick car fund going to put you on the spot and that is yes.

Basically a question of.

Why why join Lu Moe and I'm really but a mid <unk> sedan I'm, particularly intrigued.

With a C secretagogue and pulsatile release of growth hormone and how that may be different than say, a simple simple replacement therapy.

And I'm not being dismissive of the convenience and compliance benefit, but I'm just kind of wondering mechanistically. If you could provide your thoughts on on those those different mechanism.

Well I could not agree with you more actually so what I had been attracted to with the molecule <unk> 677.

I see that I mean talk about physiological replacements.

It's been known for a long time debt once weekly once daily neither 1 of those modalities actually recapitulates the normal.

On line access.

Which is basically a very low base hold with spurts of growth hormone, mostly at night multiple peaks.

And.

I was struck when I was at Merck with.

I mean, he was he was an oral agent you can take more on each ticket the evening and what it did was simply enhance the normal local non peaks.

On a marvelous design of a drug.

Now when I was at Merck Merck was all about large population, where the antithesis of a company.

I was interested in a in a rare orphan indication.

So.

This was a beautifully designed drug and they wanted to try to.

Search out a big population and they chose shakopee in the elderly, which unfortunately locked in I think continues to lack a registration endpoint.

So that was their intent I think to make a large market like.

Hypertension, Hyperlipidemia osteoporosis out of.

Out of this molecule, but they had enough faith in this day did license it to a colleague of mine like a foreigner for redevelopment in.

And Pega HD and.

I am very excited about this line.

Bullish about transcon growth hormone.

A little bit less bullish for freedom of religious about so on pathogen but.

What I see.

When I retired from.

And then just last September I was very happy.

In my 600 patients with Stanford and doing some consulting.

And I really did not have any intentions at that time of getting back into a full time position. So when we're called me and I realize what this molecule ones.

I mean.

Net.

What excites me is that I've been able so far to bring 3 effective.

Can you really 3 potential NDA has been brought to effective drugs to patients in very soon a third drug to patients for unmet medical need and I view this opportunity with Lou most as my last.

Great chance of bringing a really effective drug to a significant unmet need in patients.

I think that for.

The appropriate patients this will be a V.

Very very good treatment of their.

Of course from a deficiency.

Did I answer your question.

Yes, absolutely and really appreciate all the color I am looking forward to seeing it move forward as well.

Last question is for for Rick perhaps on strategy.

I guess you mean.

And the pipeline and it would seem to me that you have your kind of your hands full with lunar 201, and it's a promising candidate and I guess I'm wondering.

How do you look at it in terms of being a pipeline in a product with other indications relative to in licensing opportunities. It would seem to me that the capital markets have kind of competed against you with regard to latter aspect of debt or or route in terms of that strategy and I am.

Wondering if there is a fabry, leading additional indication that you would want to highlight for Luna to them on.

I see.

Good question Chaz.

Hey.

First and foremost our priority remains to stay focused on executing on our on our.

More growth to 10 study and 212 study plan.

I think that also evaluating other indications.

<unk>.

Compound because of its unique mechanism of action would likely be beneficial and provide.

And we're going to provide updates on a on a.

At the appropriate time, when those plans are more fully cooked.

But I obviously.

<unk>.

Unique opportunity with this compound.

And because we are and we are engaging all of the important kols out there.

As we lay out our plans youll be the first to know.

I think it's prudent for us though to continued based on on our extensive backgrounds on the rare disease space.

Continue to look for opportunities or are there other assets out there now as you know we've been doing this for quite some time and we havent pulled the trigger on anything and Thats, because we have been as as careful and judicious as we possibly can because anything that we do we want to make sure that this a strong <unk>.

<unk> proposition for our shareholders and that's all there is to it.

But I think it would be imprudent for us not to have a process in place.

To find a unique assets just like the unique assets that we're developing in low to zero 1.

Yes.

Very good thanks for taking my questions.

I appreciate the update.

Okay.

Your next question comes from the line of Ed White of H C. Wainwright. Your line is open.

Good morning, Thanks for taking my questions. So maybe start with a question for Laurie curious as to.

R&D spend going forward.

We would expect to see the trend going up as their trials for initiated sequentially R&D expenses were down I'm. Just wondering if you can give us some thoughts on how we should be thinking about the next 2 quarters for R&D expense.

Sure and thank you for the question and so sequentially compared to Q1, we had some <unk>.

Severance costs that were recorded in Q1 for the departure of our former CMO of approximately $1.4 million.

And I would expect and anticipate that our Q2 spend is reflective of what we will expect going forward with increases as we advance our clinical trials and path for in towards the register for that Phase III trial.

Great. Thank you.

Okay.

John Congratulations on the.

On your new role.

Title I'm just wondering how your your role is changing within the company. If you can give us any any thoughts to that.

Well. Thank you for you for the congratulations Ed and really I think.

The focus will will continue to be similar to the role I have been saying I think it's.

Promotion, where I'll be able to focus on on both the operational on scientific aspects of the company and making sure that we deliver on all the aspects of our guidance.

Okay and.

And maybe just the last question then I have we have been talking about enrollment.

In the <unk> study.

I'm just curious on 2 things now that we're seeing you had mentioned debt.

As.

Children go back to school, there could be perhaps more.

Pediatrician visits.

Could see more interest in the studies I'm, just wondering how you're thinking about.

The Delta variant and.

What is that going into your thought process on.

Enrollment trends and then when could we see.

You give us an update on what the actual enrollment are in these 2 studies will you be telling us when you get halfway there or maybe perhaps over the next few quarters do you plan on giving us updates on how the enrollment is going thank you.

Yes, I'll start with that.

Ed.

We haven't.

Any timing guidance that we're going to address 1 where.

A quarter or a half for or 3 quarters away true.

We're just we just have our noses to the grindstone trying to make sure that we're doing everything we can.

To make sure the study goes as well as possible.

Perhaps we would.

<unk> the market.

<unk>.

More appropriate time, but right now for a little bit too early on.

And John could you take his first question regarding the Delta virus impact.

Yeah. So I think the Delta variant, it's much like the outflow variant was last year right. So the way we plan around that is.

Right now as Rick has mentioned, we are more than 50% of our sites up and running part of our delay in the past was as much about getting sites up through delays of getting through <unk> and interacting with.

Lawyers and contract people at clinical sites, who are working from home, which seem to add an enormous amount of time.

And I think we have those sites up and running and as we have mentioned in the past we have.

Sites spread across various geographies in the U S. But also internationally in eastern Europe and then.

And in Australia, and New Zealand and I think the combination of those 2 things are really going to help us.

Kind of juggle loop from area to area, where.

The pandemic waxes and wanes.

But I also think regardless that at this point.

Communities are starting to learn how to live with COVID-19.

It's hard to imagine that we would go through another school year with the with remote learning for the entire year I think we will find ways to be successful in educating kids.

Yes, which will which will stimulate trips to the pediatrician net referrals for the pediatric endocrinologists.

If I could just endures for John just said.

It absolutely mirrors my experience getting the true.

Sales kind of PTH.

Ah studies enrolled under Covid, which is exactly what he said the delay is getting sites initiated.

Even the initial.

Epidemic did.

Did not have a meaningful impact because.

But once you let the cases diagnosed I mean, the parents really want this kid treated.

So there was really minimal impact and is subject coming into the site all of the delay was really getting the site initiated in all the hoops you've got to go through to get a site initiated so I just want to endorse for John said about that and I expect that to happen.

Link to a 1 trial as well.

Yes.

Great. Thanks for taking my question.

Thank you Ed.

Your next question comes from the line of <unk> Yang of Jefferies. Your line is open.

Hi, Good morning, Thanks for taking my question. This is <unk>, calling in for Ian.

So for Dr. Karen how quick 1 question. So do you think that before starting phase 3 the regulatory agencies might act asked for additional study where you'd have to compare the efficacy of them to our line in P M positive versus negative to our share of that.

From them to on how selective advantageous activity in the positive population. Thank you.

No.

I will tell you that since Dr. Carr from just arrived I think led.

Let John start with that question and perhaps.

Finish.

Yes, I am comfortable making a stab at that but go ahead.

Yes, so I think.

We have merged previous.

Dataset.

Debt, we've analyzed and we've separated out PM positive and PM negative, but theres a dramatic difference obviously, we published on that.

So I do think actually that the.

PM positive data.

Prospectively selecting those patients and bringing them into our ongoing trial is really going to be the proof that the FDA and I think the.

The market.

Well appreciate as well to show that this this enrichment strategy really does work effectively and remember this enrichment strategy is based on physiology right. So the kids who are <unk> negative.

Simply don't.

Don't have an active assets they don't have enough somatotropin, they can't store growth or were on theyre not going to be able to respond to our drug which is just going to.

Stimulate the release of endogenous growth hormone.

So it seems mathematical when you look at how we generated that data, but it is tied to physiology and I think we can make that case very effectively to regulators as well.

In a scientific setting to show that as long as we can show the PM positive kids are growing and we're able to enrich that population of responders with our cutoff I think I think that will be sufficient evidence.

And David do you want to add anything.

I'll just say that on the 1 hand. This is my second day at the company.

But on the other hand based upon my 30 years of experience dealing with endocrine metabolic group I can say with I think somebody already are the following first of all I think the agencies like third party payers are would be absolutely thrilled at the selection process to identify the best patients for the drug I think that the phase III trial, if I had to guess.

H for basically.

About a 2 to 1 randomization between <unk> selected patients for the link to our lung group versus unselected patients for daily growth hormone and it would be a 12 month study and the likelihood of having to go for PM positive versus being negative I would handicap as as close to zero has to be.

Negligible.

This is there's just no there's no rationale for that.

I would be willing to bet a lot of money it'll BPM selected vs. Unselected for daily growth hormone that will be the phase III study.

We shall see.

Great. Thank you.

Your last question comes from the line of Catherine <unk> with Jones trading your line is open.

Hi, Thanks, very much for taking my questions I had a couple on pipeline expansion possibilities.

First as you think about potential BD opportunities what are some specifications that youre looking at in terms of assets that you think makes sense in your portfolio.

Catherine Thanks for your question our criteria is really always included.

Starting with a good strategic fit.

Strong scientific rationale and really strong value proposition for our shareholders.

We have been willing to look at the earlier stage opportunities is going to continue to do so on a very selective basis.

But.

And above all we'd like to stay on the endocrine space I mean.

We have a lot of experience and especially with the.

David arriving I think the opportunities will are going to expand for us to look at.

And our process I think is a very good 1 but.

As you know, we havent pulled the trigger on anything because.

Sure.

It Hasnt met are really careful and judicious.

The criteria.

Yeah.

Thanks that makes sense and then when youre thinking about expanding link to a Hawaiian into these other indications where growth hormone is a true do you have an idea of what subset of patients who might benefit from that moving to a 1 unique mechanism of action.

And John why don't you start with that.

Yes.

So.

The only.

Growth on a deficiency population that link to on its been tested in right now is in the.

Just on the PGA HD population right. So that's the population where we have a correlation there perm tests back to growth rate from the outcome.

So each of the other indications that growth number for them is approved then has.

Unique assets to 2 the etiology of the disease right. Sometimes there are things there is some growth on 1 deficiency and there are some downstream modulation of receptor activity or IGF oner activity.

So that's really where we've been spending our time, that's looking looking through all of those assets and trying to understand really the overall potential of link to a 1 and in that area and also thinking through how wood poles utility effect.

Each of those individual disease states versus the bullets right. So we have good ideas of how that how that might have an impact on ph D and we want to understand that for some of the other indications.

And then once we get past that we do try to assess how Frank is the growth from a deficiency itself.

And each 1 of these indications and that's really can be an indicator of.

Where our mechanism of action of stimulating the release of endogenous growth on a on there's going to play in each 1 of these indications and that's that's really.

What we are building that that data set through mining.

Mining.

Information, that's our history data about each 1 of these diseases right now too to put together, our prioritized list, because where we're going to go forward.

Thank you very much.

Thank you Catherine.

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

Well, we thank you for joining us today, and we look forward to keeping everyone apprised of our program over the course of the year.

You very much.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

Q2 2021 Lumos Pharma Inc Earnings Call

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