Q2 2019 Earnings Call

At this time all participants are in listen only mode Theater, we will conduct a question and answer session instruction will follow at that time.

If anyone has any offers us in any time. Please press star then zero on your Touchtone telephone.

I would now like to turn the conference over to your host Kevin Lynch Chief Financial Officer, you May begin Sir.

Good afternoon, everyone. Thank you for joining US today, we hope you had a chance to review the news release, we issued earlier today announcing our second quarter 2019 financial results. Joining me on today's call is Amit Munshi, our president and Chief Executive Officer, Dr., Preston Klassen, our head of research and development.

Before we begin I'd like to remind you that we'll make forward looking statements that involve risks and uncertainties, including statements about our focus plans goals strategy expectations R&D programs regulatory activities products and operations and those of our collaborators in license fees and other statements that are not historical facts.

These statements are made in the context of the risks and uncertainties that are discussed in our filings with the U.S. Securities and Exchange Commission, which can be found on the FCC website at Www Dot FCC Dot Gov and include risks related to timing and outcomes of regulatory decisions and discussions timing of preclinical and clinical trials, including patient recruitment for clinical trials, which is competitive and challenging it may take longer than we project preclinical and clinical results and the timing of such results, which may not be as expected or sufficient for further development regulatory approval or commercialization collaboration and licensing activities and the amount and allocation of our available financial and other resources. Our actual results may differ materially from our forward looking statements now I'd like to turn the call over to Amir.

Thanks, Kevin and hi, everyone and thanks for joining our call today.

During my comments today will provide pipeline update on the timing body worn out a clinical programs as we continue to advance our promising programs.

He will then conclude with a financial review of the second quarter of 2019.

Arena continues to make strong progress on all fronts clinical operational and financial.

2019 was an important year of execution.

As a company and thus far we have met or exceeded and continue to exceed all the objectives for the clinical programs.

We've got a busy start to the year by delivering positive open label extension did overcrowded modern you see.

Closing, the United Therapeutics field, it secured a strong cash position.

Initiating a kosmotras phase three elevate global program for ulcerative colitis or do you see in June .

And most recently initiating a warrant ABS grades to captivate trial for abdominal pain associated with irritable bowel syndrome.

In July .

Across our pipeline, we anticipate initiating additional programs this year and delivering multiple clinical milestones next year.

We believe we are uniquely well positioned with a potential best in class later stage programs World class team of course, that's growing balance sheet.

So let me start with a TRASM on.

Because one of the only.

There will be characterized in house developed next generation.

Once daily oral asked when P. modulator.

The unique receptor selectivity in pharmacogenomics.

As a next generation S&P modulator, a crowd that has the potential could be the proposed rule option for patients suffering from a broad range of grievous people decide mediated immune and inflammatory disorders.

Our phase two data suggested the Transmode has the opportunity to be the best the disease ops all option for patients suffering from ulcerative colitis.

This quarter, we initiated the global phase three elevate you see Registrational program, which aims to include over 40 countries and will consist of two trials to evaluate the cosmos two milligrams in subjects with moderate to severe active ulcerative colitis.

Firstly elevate 52.

A treatment trial with the 12 week induction grateful, but 40 weeks of maintenance in approximately 370 subjects, which we initiated in June .

Secondly, elevate you see 12, a 12 week induction trial, approximately 330 subjects, which is expected to initiate a staggered manner to optimize time to market.

Importantly, we're planning additional trials to provide evidence of differentiation for health care providers and critically for payers.

We look forward to sharing more details on these trials overtime.

For indications beyond ulcerative colitis person will provide an update on our progress in crohns disease, and the atopic dermatitis.

Beyond these initial indications we are excited to further evaluate because my multiple indications going forward.

We continue to believe that the program offers tremendous promise in the treatment of broad range of immune and inflammatory mediator condition.

And we look forward to sharing our plans on the additional new indications with you later in the year.

So with that let me turn a good person to discuss the Crows program. The atopic dermatitis program and the continued progress on.

[laughter].

I'll start with the TRASM odd on the status of additional indications beyond Ultra Kaleidoscope, we plan to initiate this year.

In parallel to executing on the elevate you see program, we're rapidly progressing toward the startup of our phase two three program in Crohns disease.

We're working to get the transmode rapidly to patients who can benefit, particularly in an area of large unmet medical need like crumbs.

We are in the process of finalizing protocols for these trials after which additional details regarding study design startup plans in overall program timelines will be shared we remain on track to initiate a program around the end of the year.

In addition to inflammatory bowel disease, we plan to begin testing attracts much in dermatologic diseases, starting with the phase Twob trial in a topic dermatitis strong body of experimental and experiential evidenced a preclinical and clinical data.

Give us confidence that attracts not highly selective profile at the S&P, one and S&P four sectors has the potential to yield unique benefits to patients suffering from moderate to severe atopic dermatitis.

Current therapies break happened dermatitis have efficacy in a limited set of patients and range from simple emollients to newer injectable biologics.

I know the topical therapies, we believe that there is significant opportunity to move this field forward with a once a day world regimen.

That makes safely impact not only the German watch manifestations, but potentially synthetic implications he talk dermatitis as well.

But its program, which we have branded as the advise trial.

We are and study startup mode with the expectation of enrolling patients later this year.

The study will be a multi center randomized double blind placebo controlled trial testing two doses of attracts a lot in patients with moderate to severely active atopic dermatitis and inadequate response to topical steroids.

Approximately 120 patients will be enrolled for a 12 week treatment period.

At a four week follow up observation period will.

Continue after that.

The primary endpoint will be the percent change in eczema area and severity index or EASI score from baseline to week 12, and secondary endpoints will include the proportion of patients achieving an easy 75 score.

And changing measures the brightest among others.

We are excited to be initiating worked with the tragedy in dermatology and we look forward to updating you on our progress.

Now I'll switch gears to a lower and have our peripherally active highly selective.

Full agonist of the capital type two or Cbtwo receptor.

We believe that this product has the potential to be a significant advancement in the treatment of visceral pain and in July .

We initiated a phase twob clinical trial branded captivate.

Targeting the treatment of abdominal pain associated with irritable bowel syndrome or I'd, yes.

Abdominal pain is a hallmark of I guess and the majority of patients who suffer this disease describe regret abdominal pain as their most problematic symptom often significantly impacting quality of life.

We believe that there is a high degree of unmet medical need for pain management in G.I. disorders, such as Ive, Yes, importantly, because current evidence suggest that werent adds mechanism of action is directed to pain management, rather than motility. This compound has potential across all facets of idea constipation predominant diarrhea predominant and mix.

The phase Twob trial captivate.

Because the multicenter randomized double blind placebo controlled 12 week study of alone have in patients with ideas.

Very infrequent abdominal pain.

We will include both patients with constipation predominant or IVC, IVC and diarrhea predominant obvious D.

The primary objective of this trial is to assess the safety and efficacy of three doses of alumina and administered three times daily compared to placebo and the primary endpoint is improvement in the weekly average abdominal pain scale or eight P.S. from baseline.

We will also be looking at some key secondary endpoints, including the proportion of patients who achieve at least 30% were more improvement in a P.S. and the mean change in number of paying three days per week.

They have to be trial will enroll approximately 240 patients.

We are planning on the availability of data in the second half of the year. We look forward to updating you on the progress of this program as appropriate.

And finally on the organizational front, we would like to discuss a reallocation of responsibilities within our R&D management team.

As of this month I will ship, the Chief Medical officer function to Dr., Chris Campbell, who has served as a senior vice President and head of clinical development at Arena since October of 2017.

Dr Capital will continue to report to me and I will continue to serve as the head of research and development.

Overseeing global R&D strategy portfolio prioritization and expansion of our pipeline.

Management of the functions within R&D and external interaction.

Dr Capitals that Ukraine cardiologist within NHS degree focused on clinical research prior to joining arena, Chris spent 10 years at Quintiles now I, Cuba in a variety of senior management positions, including Chief Medical and scientific officer.

As CMO at arena, he will oversee the clinical development clinical operations bio informatics and safety function.

Has there been any increases our programs, our clinical trial and patients enrolled ultimately, culminating in large patient populations that may be treated with our products.

Shifting medical oversight responsibility to Dr. capital increases, our bandwidth and flexibility across the R&D group I'm grateful to have partnered with Chris for almost two years now at arena.

I am confident that its clinical operational and strategic expertise will continue to serve the company well and sure excellence and efficiency and the progression of our clinical programs.

And I would like to try to call over to Kevin for review of our financials. Kevin. Thank you pressed him I'll provide a brief review of our second quarter 2019 financial results here, while more detailed results are discussed in our press release from earlier today and in our 10-Q, which will be filed this week.

For the second quarter 2019 revenues for the second quarter were 1 million with 900000 of royalty revenue in terms of costs.

Research and development expenses totaled $51.2 million, including 7 million related to noncash share based compensation.

General and administrative expenses totaled 18.4 million of which 6.4 million was stock based comp.

We burned approximately 48 million in cash this quarter net loss for the quarter was 61.4 million or $1.24 per share on a basic per share basis.

At June 32019, cash cash equivalents and investments balance was over 1.2 billion and approximately 49.8 million shares of arena common stock were outstanding now I will turn the call back over to on it.

Thanks, Kevin.

Well continue to make significant progress across the board delivering on several key milestones.

As we build a world class company with best in class products.

Continue our relentless focus on execution. The team that has delivered and will continue to deliver and of course with a strong balance sheet.

We are uniquely positioned to deliver on building this company.

We're excited to share all these programs the progress the team has made so far this year.

Most recently with the initiation de elevate you see phase three global program for the TRASM by most of the slightest.

And the captivate phase two trial for a more nab him I B S pain.

We look forward to sharing the exciting milestone had including the initiation of the crohns disease, and they kind of Dymatize trials.

And continue to advance the remainder of our pipeline.

Finally, I'd like to take this opportunity to thank the entire team for the fantastic work today.

And to thank our investors for your continued support and with that I'll turn the call over to the operator to begin the QNX.

Thank you ladies and gentlemen, if you have a question at this time. Please press Star then one on your Touchtone telephone.

My question has been answered or you wish or move yourself from the queue. Please press the pound key.

To prevent any background noise <unk>. Your line Whats your question has stated.

And your first question comes from.

Cantor Fitzgerald your line is now open.

Hey, guys. Thanks for taking my question and congrats on the progress in getting some of these trials underway I guess two questions for me one.

Macro standpoint, it's not a lot going on with JAK inhibitors, you know whether it be ones in the pipeline are ones that are on the market.

Wanted to get your perspective, as you think about the landscape and the positioning of the TRASM.

And my second question is a little bit more around the R&D, which is I'm just curious kind of how you guys think about leveraging the de couple of protein receptor platform. As you go forward and my what targets and maybe what indications might be particularly interesting from you from here. Thanks.

Great.

Lisa This is Amit let me start with the JAK inhibitor question.

The landscape is absolutely fascinating and I Weve showed some of this in the past.

It's important I understand the two out of three moderate to severe ulcerative colitis patients have never see the biologic and there's sort of sitting out there on conventional mads flaring increasing steroids.

And in and out of five yesterday for example.

So there's a wide open market opportunity here for novel agents into the field and.

As you've seen from multiple pieces of research patients.

Routinely select.

And over injectable agents.

In the old category. The JAK inhibitors have made an initial push I think it's important to understand.

That all being walk a JAK inhibitors have a class warning for increased increase was a malignancy.

Yes infection events opportunistic infections, herpes zoster tuberculosis, and importantly, GE I perforations so.

And of course, we've not seen any of those things with the S&P modulators to date.

They all have their own label increase somebody convince again, both here in the U.S. and you.

Well, we've seen this across really the entire class of agent. So in terms of the risk benefit profile. As you know we demonstrated best in class efficacy with an oral agent with the 12 minor phase two study we look forward to confirming that in the phase three study in Minnesota, confirming the strong safety profile. The products. We think given the fact that loans are routinely selected over biologics, we seen a best in class best in disease type activity out of the phase two program and the fact that two out of three patients with moderate to severe disease have never you're going to see the biologic. We like this market is prime for a TRASM odd.

I hope that answered your first question on moving up here.

Yeah, maybe to your second question on the GPCR platform, we haven't disclosed the specific targets that were looking at we the historical platform.

In the Beacon discovery, we are sort of right of refusal from Beacon discovery in therapeutic areas in which we participate including Gastroenterology and we continue to work very closely they remain on our campus we.

They continue to do contract work for us not only under existing programs, but on future compounds as well as we continue to prosecute against research targets, we'll come back and discuss some of those when the time is right.

Great. Thank you.

Thank you and our next question comes from Martin <unk> Oster from Credit Suisse. Your line is now open.

Hi, Good afternoon, everyone. This is you carry on for Marty Thanks for taking our question.

Actually I have a couple of quick questions. One is going to be for the CD trial first off congrats on the progress there in terms of getting that initiated I know you've mentioned before that you've been applying your proprietary enrollment strategy. So much where you did you see.

Can you kind of provide some more color or some of the gating steps into a initiating this trial by the end of the year.

In addition to that can you speak to the regulatory.

Perspective on the trial they give is going to give you. The go ahead.

On the design, so I know, you're getting wouldn't be aggressive and kind of be the historical timeline. So for sea trials. So additional insight on that would be very helpful for us.

Yeah sure. This is pressing Mike and I can take that I mean, essentially we're finalizing the protocols now and then doing all of the activities you commonly consider you know part of startups that effective starting study start up activities to get going by the end of year, we won't comment directly on regulatory interactions at that at the time that we are ready to begin everything and have locked down the protocols. We may provide a little more color on the flavor of our discussions with the regulators, but we're very satisfied with the progress of the program as we have been with the progress of the easy programming and just do you.

To your point about.

What we consider to be a very cross functional and hopefully innovative approach to trial enrollment that we are conducting with ulcerative colitis with the all that you see programs. We of course will be leveraging all of that include a global problem network of.

Over 40 and 50 sites.

For the you see program into the Crohns disease program. So there's going to be a lot of synergy in terms of the work that we need to do with problems and so I'm happy that we're getting started.

Strong fashion on the Juicy fun.

Thank you for us.

Thank you and our next question comes from Kennen Mackay from RBC capital markets. Your line is now open.

Hi, This is Justin on 10, and thanks for taking the question couple from US on deal Lauren I'm trial.

Wondering sort of more broadly what you see is the appropriate treatment comparisons. There currently used to treat I'd be associated pain, and then specifically for the trial could you talk a little bit more about some of the baseline screening criteria that's being utilized there.

Sure. Let me this is up and let me take the first part of that and know how about the second part to Boston.

Most patients with IDFC today as you might know were treated with the agents that impact Kennedy.

Some of these agents have secondary activity on pain bloating.

And that's really how they're handling truly just idea.

In our study will can be involved but I b C and D patients so expands the universe quite considerably.

Important for this compound is that that we don't believe at this juncture that there's any activity on well told him that nor have we seen any from the previous work that we've done we do believe that the.

Cbtwo receptor is involved with visceral pain broadly and so we think it's a great place to start at the bottom the syndication. So just to give you a sense, possibly the market is broken up into a third a third a third through the market as IDFC. A third is idea you know and the third is ideal mix and totally be addressing about two thirds of the market. This trial.

Most of these patients can be handled with over the counter agents in terms of come easy just wondering if the paid that's a significant issue for these patients and that's what we're hoping to address with what the program, especially if you're using question. Yeah. Just in terms of Ah inclusion kind of first and foremost the patients have to have.

Abdominal pain on a on a daily or weekly basis, using that a P.S. average abdominal pain scale to have an opportunity for benefit and so it's got a classified on the moderate to severe.

Abdominal pain, the vast majority of daily pain.

And then.

The study is particular control using testing three doses and especially taking all comers basically with with the requisite amount of abdominal pain.

[noise].

Thank you and our next question comes from Joel Beatty from Citi. Your line is now open.

Hi, Thanks for taking my questions. So first one is on the all of a phase three program are you.

Provide any details on just general and enrollment at or just sites up and running and ended. The second question is you know obviously, there's lots of potential indications for <unk> TRASM I'd be on do you see an uneven beyond crohns disease, and they topic dermatitis too.

Are you able to discuss very just some high level thoughts on expanding to additional indications for a trust.

So well have person to take the first part okay. Yeah sure I mean, the quick answer is it's early days, but we're on track, we're not going to be giving you know weekly or monthly or even quarterly necessarily update specifically on enrollment that kind of thing, but but as you know as you well know he's a large global programs.

Well car a lot of infrastructure to get things up and running and to give the competitive landscape. So weve, taking up picking it up I believe a fairly conservative approach in our planning.

And I'm very pleased with the progress that we've shown today.

So just thinking about new indications we've had teams you're working internally both for me.

From a desk research point of view has lost when the translational medicine point of view and thinking about additional indications and therapeutic areas as you know.

S&P modulation, specifically PRASM odds with activity on the one in four receptor a allows us to go into lots of different directions as Christian mentioned.

Dermatology remains really interesting to us of course, gastroenterology resisting glass and there's a whole slew of indications in just those two therapeutic area. So you can you can anticipate that thinking sort of therapeutically focused initially and then beyond that thinking about other immune conditions, which linda lend themselves to the same kind of markets would be going after so long term perspective on how we eventually commercialize these indications.

And how we build out the franchise. So that's kind of how we're thinking about and we're excited.

That could be in a position that perhaps later this year, we'll be talking a little bit about some of these new indications and the kick starting in 2020.

Great. Thank you.

Thank you and our next question comes from Jason Butler from JMP Securities. Your line is now open.

Hi, Thanks for taking the questions just a couple on trial design for the advise trial could you.

Speaks to the enrollment criteria in terms of prior treatment with biologics and then on Captivate are you stratifying by IBSD versus de Anna Yu powered to show differences in the two populations. Thanks.

Yeah sure. Thanks, it's depressing and I'll take question Jason.

So first in terms of a Florida and the two obviously and IBSD.

We will definitely be Stratifying, we anticipate penalize you would expect a 50 50 split overall into the population and then randomized.

Accordingly within each of those will necessarily be powered.

For each individually at the phase two study this is to give us a directional confidence that we can go into a phase three study so I'm comfortable with with the overall powering of the study as it exists right now and the ability to tell US Directionally is this a drug that has we suspect has equal play across all of the different types of motility categories with an idea obviously just looking at C and D. Right. Now we May go ahead and use. These data then to give us confidence that in Mexico. We may end up doing another small study are related to mix prior to going into phase three but is all that said across these populations. It's about a third a third a third for the different types and what I'm really excited about is it.

My my belief is we just need to bear that out with data that that alone App should have potential across all of these and then I'm sorry. Your other question I was in a topic dymatize.

So it's predominantly well first of all all patients have to have moderate to severe reactivate D.

And I have to be.

Inadequate response to topical steroids he will allow a prior biologic therapy is obviously not concurrent with the use of the of the compound. We generally anticipate that most of the patients will not necessarily be on prior biologic several watch to see how that shakes out if we can get involved.

Okay, great. Thanks for taking the question.

Thank you and our next question comes from Joseph Joseph Senior from Needham. Your line is now open.

Hi, This is Joey on for Alan Thanks for taking our questions couple more on captivate just curious.

In the phase two trial had a 25 Meg in the 100 make goes and.

Oh, you're talking about three doses for the phase two b.

<unk>.

I know you sort of give a background on sort of the dose selection there.

And also what you would expect in terms of.

Drug response versus a placebo response in the phase two b I understand phase two way was not not placebo controlled and it was eight weeks versus 12 weeks and that seems to be some maybe some.

Some additional color on that would be great. Thank you yeah, yeah, yeah, Yeah sure I'll start off by saying that we're not going to be disclosing the specific three doses at this point.

Related to some intellectual property.

But I can speak to what we've done before and then just high level. How are you thinking about the dose ranging so.

As you stated in the initial phase two a kind of early read study.

We had a small number of subjects, who were on either 25 or 100, and what we saw in Matt and as you pointed out not placebo controlled.

So at a high level, if you look at the literature for a P.S. kinds of.

Scoring system, you generally think that.

That about a 30% response at least could be considered.

Placebo in nature.

And so when we were thinking about the phase two study and what it would take to essentially convinced us internally that it was worth moving forward with additional robust phase twob dosing work.

We said well the result, better be a lot more than 30% and what we in fact saw was 100%. So all responders I'm sorry, all patients at eight weeks, but the 25 and 100 Meg dose showed a response in this was defined as the VFD categorical.

Endpoint of at least a 30% or more reduction a P.S. score from baseline and so it was great to see not going so well what it what about that dose in terms of 25 and 100 very specific we had targeted 25 milligrams as a dose that we believe based on receptor occupancy studies essentially covered the receptor. We thought 25 milligrams was pretty much.

For the full on dose and then we decided to quadruple that just to see so this again. This is a very small early study to give us reason to move forward with more robust phase two testing and so as I said it looks great in terms of what literally 100% response.

And but now we have to move into an actual placebo controlled real dose ranging study and so again without going into specifics about the doses selected we're targeting around that lower end dose both on the low end higher side and.

Obviously with the placebo group and its well powered at about 240 subjects overall, we will be able to distinguish that dose response that we expect and and obviously changes.

Over placebo to to give us confidence to move into phase three so the phase two study is absolutely designed to lead into a pivotal phase three program.

Great. Thank you.

Thank you and our next question comes from Jessica Fye from JP Morgan. Your line is now open.

Hi, This is Danielle thanks for taking my question one at least spots on increased clock reported with L. Johnson.

And what it means for enrollment.

Thank you.

Yeah. So it's a great question I mean, let me start with that I think it's important to remember that.

Unlike our ray.

Other autoimmune conditions patients have an increased risk of BT.

In ulcerative colitis so.

Almost a two X increase risk over over a normal population. So the risk is already there.

When you think that this mix S&P modulation a.

Potentially preferred option over the long term in the IB category.

It's also not just to be teases seems like G.I. perforations as well.

It's tough to know right now what it's going to look like for it and from an enrollment perspective.

It's.

It's early days in our clinical trial start of his presence and we're very very pleased and on track with all the parameters in terms of our studies started so well be watching and monitoring that carefully in terms of the impact.

We think long term from a commercial perspective, all of the JAK inhibitors.

Have a series of liabilities that that the S&P modulators do not and.

Typically a TRASM on has what could end up being potentially the best in disease profile. So we're very excited about what this ends up as to where it plays out on enrollment will let time tell.

Thank you.

Thank you and our next question comes from Joseph Schwartz from SVB Leerink. Your line is now open.

Great. Thanks, very much and congrats on all the progress I was wondering first of all on or Nab or how does the etiology of visceral pain associated with I'd be S. C and D compare to that in IB D. and what gives you confidence that the benefit Oh, Lord have demonstrated in the IBT patience you treated is translatable to the I.B.S. patients you're targeting now.

Yes, that's a really great question. Thanks, Preston so.

The.

Cbtwo receptor is predominantly express in the Gi tract and in other.

Additional areas is essentially and.

Specifically up regulated.

When there is inflammation in the system and in particular.

One of the reasons why we chose quiescent crohns disease too.

I bet first initial phase two a look.

He because literature reports showing specifically up regulation of the Cbtwo receptor in the margin of lesions in patients with Crohns disease.

Now we know that idea.

And.

The pain associated with Crohns disease, he is actually where the model from a preclinical perspective, it's actually very similar.

The way you generate a an animal model of Ivy asked is you initiate essentially an IB de like picture within inflammatory insult.

And then you remove that macro inflammation and what you're left with is a hypersensitive colon.

And there is still at a micro tissue level in inflammatory mill you present.

And so we think there's plenty of pretending there's also been.

A variety of scientific papers, showing up regulation of the Cbtwo receptor in IB yes.

So basically I guess it looks an awful lot like I'd be from a from a pain perspective without necessarily the intensity of the macro inflammation. So it's more like a quiescent crowns.

Yeah. He is very similar to Ivy asked and that's it's very similar from an animal perspective, we believe there's enough similarities from a from a patient perspective for us to move into rvs as the phase two.

Theres no question that the unmet need.

In terms of pain control and I guess he is large we believe that enrollment will be.

Something we can readily accomplish and we're looking forward to it now.

Down the line I should we show.

Solid efficacy and safety with a loan at an Ivy, Yes, I think it would stand to reason that we could go back and think about getting back into Ibds, specifically crohns disease, and figuring out how a pain specific therapy would work in combination with other therapies that are actually.

Disease, modifying or were focusing on that macro inflammation. So that all have to get worked out a little more complicated in terms of of of IBT in crohns, but but we'll start here with RBS.

Okay. That's helpful. Thanks, and then on.

Hey, D. Given depicts an uptake has been very strong in a TRASM not won't be on the market for several years.

When comfort with Dupixent should be even stronger I was wondering how you see the opportunity when you hope to come on the scene in the quantum of data or product profile that you need to make a significant impact on the future 80 markets.

Sure so.

Avi like a lot of other conditions.

The even the top end of the efficacy result leaves a lot of patients.

Without without complete resolution.

So the market will continue to evolve over time, there's not that many therapeutics in there today.

The market is approximately six to seven times in terms of patient population the IP landscape.

So you have a huge disease burden across a broad range of patients and you only have a limited amount of therapeutics and.

On the Vixens, great drug and the challenge of the payment of course to biologic.

And all options are always preferred in terms of.

Being able to move there, especially specifically all options that have.

The safety profile that weve, so far seen with.

With the plasma.

So we think that the landscape will continue to shift the landscape will continue to grow the the making sure. These patients are getting into the clinic, making sure dermatologists aware new treatment option.

It's really going to drive this market over the next decade, so very early days in the market.

One biologic on the market with some with that because he that's that's good but again, there's a long way to go both in terms of the magnitude of effect.

The safety profile and of course, having all auction.

Makes sense. Thank you very much thank you.

Thank you and our next question comes from Jim Birchenough from Wells Fargo. Your line is now open.

Hey, guys, it's Joe on for Jim Thanks for taking the questions and congrats on all the progress this quarter just a couple from US on that you see program, maybe first or how you're thinking about the timing of the 12 week trial.

If the staggering is intended to time to read outs for both simultaneously.

Any insight you can provide us there and second knowing that the three domain scores ft required endpoint for you see if at this point you could provide us any insight on the powering of the trial and maybe how you define success even at a high level.

Yes, sure I'll take the question I'll take the first question just related to the staggering of giving the elevate you see 12 study.

Under way more than I was thinking about the data read out on the backend I mean, we do believe that though that you see 12 and you see 52 will ultimately kind of read out around the same time that wasn't necessarily the driver. The driver was that were developing a global network of sites.

To to engage with enrollment and the 52 weeks day, obviously by definition is kind of the long haul and the tenant and so we wanted to get that started first and get enrollment either completed or or.

The vast majority of the way forward prior to.

Beginning the you see 12, the shorter study.

So that's it more and more and more a matter of trying to stagger. The moment. So that we are covering our sites across the globe that.

Adequately and then again on the back end it will it will make things probably read out around the same time, but that was not the big driver and then I'm sorry could you repeat your second question.

Yeah, just you know on kind of the powering of the trial. If you could provide any insight there and maybe how you define success at a high level.

In terms of you know endpoints and what you'll be you'll be looking for.

Yes, I I just covered some of that out at a high level look at the phase three program, we're not going to underpowered anything.

We I think as we've talked about in our discussions with the FDA and we're taking a look at both.

Oh clinical remission at the 12 week time point and the 52 week time point.

As a co primary.

And so.

That that is a two endpoint.

Combination needs to have a high degree of power and you have that.

And then in terms of.

Oh, there just the other aspect around the end point just to be really clear. This is using the three domain.

Definition of remission as defined by the Mayo clinic score.

Domains of stool frequency rectal bleeding and then endoscopy scores. So this is unlike the.

A previously approved products that have used the total mail for domain score.

So we've been very disclosive in terms of our phase two data, which was based on what he is now the phase three standard.

Based on the assay definition in 2016, so we've shown our phase three threed on that started phase two three domain remission data and that has been used in a conservative fashion to help power the underlying assumptions for for the phase three programs are really comfortable with where we sit and overall plans I think it's as we've talked about in the past the program itself is released.

Streamlined focusing on speed to market.

In that we've got a treat to design that ends up saving us several hundred patients in terms of deal size of the program and so we're doing everything we can to.

Hi, Julie expedite progress with this program and get a get the patient.

Get to them to patients as quickly as possible I think it's also important just to understand that.

Unlike other programs, where we've never seen three domain data from their phase two.

Good and then phase three that started with the three domain.

Information, we especially mentioned we've been higher this quarter than I've ever we had a very significant number from 26 point Delta on three domain.

Mission.

From our Oasis phase two study and it's a direct read through to the phase three so were we think thats really important point in terms of.

Our confidence in the phase three study design, the powering assumptions et cetera that that we have.

Very clear read through from our phase two study for phase three.

Great. Thanks, guys.

Thank you and our last question comes from Patrick Trucchio from Berenberg capital markets. Your line is that we will thing.

Hi, Good afternoon. My first question is regarding Lauren.

Scott what are the advantages of CB too.

Mike.

As compared to delayed relief, what ACA tied up for how we should expect to learn to compare to delayed relief for naco tied from an efficacy perspective on the abdominal pain scale and patients compared to what we've seen demonstrated from that compound, which may enter the market ahead of a learn.

Yes, Patrick let me just comment let me cover that I think.

One of the critical areas is.

We just need to get through this study to look at the actual impact we think the mechanism is definitely do you think.

He too has a broad range of applications across lots of this whole pain indications we started in July .

In IB, Yes, just simply because it's a nice fit overall portfolio as Christian mentioned, we'll also be taking a hard look at I.B.D. indications like Kronos. So it has multiple applications beyond just an idea.

Initially were all already going from IDFC, and adding IBX piece, we're expanding that potential marketplace. So just from a broad clinical utility we think a willing to have.

It's very different than the absolute or well got delayed acting on sentiment.

So again mechanistically totally different.

And again, a broader set of clinical utility applications for a more now.

Did you want anything batch I'll, just also say that.

Of course, it's too early to really be able to make any kind of comparisons I think the unmet need is large enough that it's that the market can certainly handle.

Several entrants.

When we did our phase two study looking at a small number of subjects. There was a 4.6.

Decrease from baseline in the 10 point scale and again, while that is it early and not placebo controlled.

If you look at the change from baseline for other therapies and including Linzess, you'll see that it does not come near 4.6 again, whether that is replicated in larger programs and how that fares against placebo is something we need to figure out.

It all the time, but but we're really satisfied that there is enough evidence here of efficacy to go forward with a solid phase two program that can lead into pivotal study data look good enough and we think the marketplace dynamics will still be favorable at the time the orenitram launch.

So a question on BD and specifically on the openness to further partnerships.

Tell us what structure additional partnerships could take where in the portfolio should we or should we not expect additional partnerships and which geographies.

The timing going forward in terms of when we could expect an update on this front.

Yeah. So we've we've stated publicly on numerous occasions that.

We don't particularly have an interest in partnering the transmode today.

In North America, or even in Europe for that matter, we've got the cash balance we've got the team we've got the expertise to build the company around the TRASM odd because right now there's really no particular press on a partnership option for TRASM odd so that's our current thinking and.

No if that changes, we'll let you know, but right now that we find ourselves in a really unique position.

Where where we again, we've got the capabilities we've got the capacity.

To win in the marketplace with the Cosmos and that's what we're aiming for.

That's helpful. Thank you very much thank you.

Thank you and there are no further questions at this time I would now like to turn the call back to Amit Munshi CEO for any further remarks.

Great just wanted to say thank you again for everybody on the call today, we look forward to continue to spend time in updating you on our progress.

As we continue to execute on the opportunities ahead of us.

I look forward to later in the year spending time talking about some new indications.

And the exciting things on the horizon for 2020, so look forward to talking again soon thanks, everyone.

Ladies and gentlemen, thank you for your participation in today's conference. This does conclude todays program. You may all disconnect everyone have a great day.

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