Q3 2019 Earnings Call
Pharmaceuticals financial results in corporate update conference call. This call is being recorded at this time all participants are in listen only mode.
Following their prepared remarks, we will conduct a question and answer session.
Instructions will be provided at that time for you to queue up for questions.
Now I'll turn the call over to Kevin Linde, Chief Financial Officer of Arena.
Please go ahead.
Good afternoon, everyone and thank you for joining US today, we hope you had a chance to review the news release, we issued earlier today announcing our third quarter 2019 financial results.
Joining me on todays call Islamic Munching, our president and Chief Executive Officer, Dr., Preston Clos in our head of research and development.
Before we begin I'd like to remind you that will make forward looking statements that involve risks and uncertainties, including statements about our focus plans goals strategy expectations R&D programs regulatory activities products in operations and those of our collaborators and licensees 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 at DC Dot Gov and include risks related to timing and outcomes of regulatory decisions and discussion timing of preclinical and clinical trials, including patients.
Recruitment for clinical trials, which is competitive and challenging and may take longer than we project preclinical and clinical results in the timing of such results, which may not be as expected at worst sufficient for further development regulatory approval for 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 I'd like to turn the call overtime.
During our comments they will provide pipeline up late updates and conclude.
The meaningful.
The third quarter 2019.
Arena continues to make exceptionally strong progress on all fronts clinical operational and financial meeting or exceeding our objectives across the board.
Last week.
We're pleased to have initiated a phase to advise trial would be topic dermatitis.
We believe this is an important first though the bottom of the therapeutic applications for trends.
We continue to expect to initiate a phase to be three program in Crohns disease. This year in person will provide additional kept color no plans later in this call.
Beyond you see CDN me, probably come cadence, we expect to further expand the kosmos utility in additional indications going forward.
We believe we continue to believe that a once a day all major the crowds much kupol operas glynis promise in the treatment of a broad range of immune mediated inflammatory diseases.
Look foolish enough plans on two additional indications in the next few months.
With regards to ABT four when they are published preclinical efforts are Decompensated heart failure.
We remain on track the filing gravy.
I would put or this year.
I like the trend called the depressed the divide a few specific program bookings cousins.
<unk>.
But with our TRASM on I'd be indications in June we initiated the global phase III elevate you see registration program in ulcerative colitis, which will consist of two key trials elevate U P 52, and elevate you see 12 to evaluate the transmode two milligram in subjects with moderately to severely active altered <unk>.
Enrollment in L. that you see 52 is progressing nicely and we plan to begin enrollment and elevate you see 12 and a second half of next year 2020.
We look forward to sharing additional detail on our progress with the elevate you see program over time I will note. The data from the long term open label extension of our Phase Twob Oasis trial was presented last month. It you we GW in Barcelona.
This extension trial of attracts my two milligrams up to 46 weeks demonstrated sustained efficacy in terms of clinical remission clinical response and endoscopic improvement.
Among complete or patients, who achieved clinical emission clinical response, and or kind of scopic improvement on two milligram of Transmode at 12 weeks in the a waitress trial, 75%, we're still intermission, 93% have sustained clinical response.
77% continued to have endoscopic improvement at 46 weeks of therapy.
We believe these data compare highly favorably to other existing therapies and you see.
Turning now to our second IBT indication close to these we're rapidly progressing toward the initiation of the phase two three program by the end of this year. This program will consist of a phase two dose ranging trial with an operationally seamless transition into the phase three portion of the program I will provide a few comments today about both the base to would be three segments of this program.
And we will provide additional detail early next year as we get greater experienced what attracts a lot in this specific patient population.
Our phase two dose ranging study will be branded as a cultivate trial. He will test the safety and efficacy of attracts my two milligram and three milligram compared to placebo over 14 weeks. The primary efficacy endpoint will be endoscopic response that we 14, and we will be looking out a variety of scaled crohns disease activity, including abdominal pain and store.
Frequency approximately 225 patients will be enrolled in this phase two trial.
We selected two milligram of three milligram doses for investigation in Crohns disease based on the knowledge. They didn't ulcerative colitis, we saw a clear dose response in terms of efficacy with two milligram being superior to one milligram, but its similar safety and tolerability profile across these two doses.
Because moderately to severely active crohns disease tends to be a more difficult disease to treat then ulcerative colitis. It makes sense to test two milligram and one higher does.
Based on our sad and Mad work in healthy subjects and very wide safety talks margins in our largest not human species, we do not anticipate any rate limiting safety or tolerability effects at the three milligram dose.
We will use the results from the cultivate trial, just what the most appropriate dose for additional pivotal trials in the program.
A critical aspect to this program and close diseases, the operationally seamless transition into the pace, we portion with no stoppage in enrollment activity across our global site network.
This will enable us to avoid the typical as cheap curb ramp up inside activity. When I travel is first initiated we will move from phase two into phase three seamlessly and firing on all cylinders, we will provide more detail on the operational aspects of this transition into phase three later next year.
The free portion of the program will consist of two induction trials with we randomization of clinical responders into a single maintenance trial, which is the typical registrational program using crosses Easter support drug approvals as we get or operational experience and the cultivate portion of this program, we will provide greater detail regarding the sizing powering and overall timeline for the pit.
Capital induction and maintenance costs.
We are choosing to focus on an operationally seamless phase two three programs to afford arena the opportunity to examine the beautiful cultivate make a real time decision on dose for the pivotal portion of the program.
Look we released those results in the data catalyst around midyear 2021, and you'll realize the operational synergy inherent to a seamless transition into pivotal portion of the program.
And finally I would like to highlight that we recently issued press releases regarding the initiation of two additional phase two dose ranging trial the cap to be Travelport Laurent haven't I've, yes, and the advise trial for Transmark in a topic dermatitis. Those trials are on track to provide data read out in the second half 2020, and now I'd like to turn the call over to Kevin for review of our financials.
Got it. Thanks question I'll provide a brief review of our third quarter 2019 financial results here well more detailed results are discussed in our press release from earlier today in our kind of Q, which will be filed this week.
For the third quarter 2019 revenues were 1.4 million with 800000 of royalty revenue in terms of cost research and development expenses totaled 60.3 million in Q3, including 6.7 million related to noncash share based compensation.
<unk> expenses totaled 20.4 million of which 6.6 million well share based comp.
We burned approximately 48 million in cash this quarter net loss for the quarter was 72.9 million or 1.46 per share on a per on a basic per share basis. At September 30, 2019 cash cash equivalents and investments was approximately 1.2 billion and approach.
Smelly 50 million shares of arena common stock outstanding now I'll turn the call back over to on it.
Thanks, Kevin we are continuing to make significant progress progress across the company delivering on key milestones are rebuilding world class company with best in class Palmer.
Relentless focus on execution, a team that can deliver and of course, our strong balance sheet.
We look forward to sharing our exciting milestones ahead include the upcoming initiation of whose disease program. The initiation of clinical programs, where you could equal one eight and next year feed on the warrant I've been ideas pain in the trials might it be topic dermatitis.
I want to thank the entire Wiener piece of the tremendous effort this year and to our investors for your continued support we don't seem to call over the operator begin acuity, especially operator.
Thank you.
Ladies and gentlemen, if you have a question at this time. Please press the star followed by the number one on your touched on telephone. If your question has been answered you wish or move yourself from the Q. Please press the pound.
Once again ask a question. Please press Star then one now.
And our first question comes from Patrick truck yield from Berenberg capital markets. Your line is open.
Thanks, Good afternoon, so <unk> a couple of follow ups <unk>. The first one is just you mentioned that your expectation. It's your expanded two additional indications going forward and that Youre on the trust them out and you'll share this with us over the next several months and previously I believe you got one p. commercial sales potential arbitrage.
Some odd in the therapeutic areas of liver in dermatology disease or wanting to have to 4 billion. So I'm wondering as you expand the clinical development program. Two additional indications should we anticipate the expansion to be MBS disease areas and is this estimation still in line with your thinking for total sales potential.
And these particular disease areas for trust amount.
Hi, Patrick this is on that let me see if I can just a couple different ways.
No. We would you see crowns any topic dermatitis you already addressing in the next several years about $50 billion a market opportunity so quite considerable amount of market opportunity. The new indications of we're focusing on we look for a couple of things not only the for market opportunity.
The therapeutic area fit and we look for a provocative a biological scientific rationale.
Quite your upon which we make those decisions at this point, it's little too early to to provide these specific indication specific guidance.
But but I will just say that again, the three indications wouldn't have to today addressed by 50 billion the market opportunity and with a once a day novel oral product would be unique profile of the crowds. What we think we're not a fantastic conditioned to capture.
Substantial amount of marketshare, so as we start talking about the new indication will provide more color on both the incidence and prevalence and how we think borrow products.
So just a if I may just a follow up on a on a topic term. So you know we've seen some compelling data on pfizer's joc and topic term clinicians have told US [laughter] appear similar to duty has an acceptable safety and tolerability profile.
It's a few years ahead of a trust and then there are some additional jack's on the way, including topical jocks. So the questions are how should we think about etrasimod.
Versus the is the oral Jackson a topic term do it does trust not have to demonstrate efficacy on par with these jocks or you know could safety considerations place to trust Smart ahead of the Jackson a topic term, even if not for KFC is somewhat less compelling.
So without addressing directly the efficacy question, let's just talk about said the safety profile will come back to the other piece on the topic Darren.
As you know what Transmode safety profile is unlike the jacks.
The absence of the malignancy risk today VT risk for example, upper respiratory infections, we think that will continue to play out in an indication where that's physician communities, even more sensitive to safety compared to the gastroenterologist. So <unk> moving to a broader range of applications, we're moving into specialties, where.
Dermatologist for even more sensitive to adverse event profile that we think that position to transmode quite favorably I will say that.
He topic Durham as a whole I've been under treated for very long time, the advent of the biologics starting with Dupixent is a great start we think worlds will will fundamentally change that market and this is a market that promote prevalence perspective could be three or four times just in the moderate to severe population three or four times.
Seamless ulcerative colitis increment, so in a large and growing market population, having multiple modalities.
He is gonna be important we've seen this in another autoimmune conditions over the last two decades, you had been more and more modalities allows physicians to move seamlessly between one to the other you had been world usually gets placed ahead of the the biologics. So we fix some of those patterns to continue well see how the.
The novel the newer Jackson the topic could you actually out there's still a lot of.
A lot of root beer between between here and there. So we're excited about our safety profile. We're excited about the category allergy broadly topic I'm specifically.
We think that tries modest uniquely position there so.
As time goes on I'm sure, we'll spend much more time thinking about the relative profile.
That's helpful. Thank you very much.
Thanks, Patrick.
Our next question comes from just got five from JP Morgan Your line is open.
Hey, there good afternoon, and thanks for taking my question.
Curious about the advise trial.
And given that the primary endpoint for the approval was Dupixent was investigator global assessment, how should we think about.
The sort of translate ability of your phase two and plane.
To that end point and just the implications for the design of a pivotal trial or even to evaluate idea as a secondary.
Let me hand, it off the press in person more quickly cover that.
Yeah absolutely.
Thanks for the question. So yeah. The short answer is we will be evaluating a number of different endpoints that will help give that you know the corporate read through on the phase three and so while the primary endpoint.
As a percent change in the EASI score from baseline 12, or we will also be looking at aggregate and we'll be looking at categorical cut the data as well.
75 that kind of thing so.
Going to be.
Typical for us for a.
Phase two dose ranging study, we need to get important <unk> first and foremost a good sense that number one the drug isn't the case usage of spot pick. She does that we think is bad on the basis of efficacy and safety Tolerability and and then getting appropriately to all the phase three so where we think we thought.
Have you decided and wants to do that.
Okay, and then can you just explain why you pick the percent change and easy as opposed to easy 90 or 75 for the primary.
Well one of the reason is.
The overall sample size isn't the phase three study all that's going to give us enough of a read through into the categorical, but would you see people endpoint.
Didn't think that we nearly as good and focusing on.
Capital employed for picking a dose it would work moving forward.
Okay.
And then.
Maybe putting the Jack's aside if there for whatever reason not the right comp for Youre, a topic derm data what he topic Darren drug do you see is sort of studying the benchmark for the kind of efficacy that you're hoping to drive.
Now let me let me take that one you know it's it's early days for US we don't have any data at this point.
We're speculating so I'd, rather not speculate on the effect size and what we're hoping to get out of the study what I will say is that oral agents, even if they are.
Not quite as good as a biologic in some cases tend to do quite well and I think their recent otezla transaction very clearly demonstrates the value of an old age and and in decades had substantially less up because he's in the than the biologics in psoriasis.
Sure I think if we if we look at her ESMO data, which have been published a we look at the depicts a data also in asthma models, we see.
We don't feel like we're at a in any sort of.
Can you sort of gap in terms of potential efficacy. So again long road ahead, we need to see the data, but we feel quite confident that the transmode will perform quite well in this patient setting.
And you could tell the Jackson to that that mix and you can throw.
The biologics and.
I think I think we've got a really good shot here does that missing something quite excited.
Okay, great. If I can see sneak one more than just on the financial side with advice starting up the Crohns trial, starting up and the ramp of the albeit trials are there any comments you can make just to help us kind of model R&D spend or cash R&D spend for 2020.
Yeah, We think we're not gonna give guidance on takes on it we're not gonna give guidance on 2020 today, what we have said and what will continue to say is it it's going up I think we've seen a.
Fairly big step up from 2018 to 2019 and with the number of use trials going forward, there will likely be another step up from there.
Great. Thank you.
Our next question comes from Joseph Schwartz from Leerink.
<unk> Your line is open.
Hi, I'm jury dialing in for Joe. Thank you for taking your question I first questions honest Hazmat I was wondering.
If you could walk us through what you saw in terms of Etrasimod metabolites presented at your Ats posture. So given the relatively high percentage of total activity now what is known about the M. Three any and six and their biological activity and it seems like the some of the sum of unknown traces metabolites about eight.
1.9%. So I was wondering what what sort of metabolites that was composed stuff and you know the data that you presented with a single dolphin. We're wondering if there any concern for buildup of accumulation of these metabolites stringer repeat dose.
Chris Let me at present take that.
Sure. Thanks, a lot so let's just start off with kind of a high level summary. This is obviously human by solid study that we presented Amit was conducted in the way. These things are conducted a regular label Cosmos.
We were covered a high degree the amount that you're supposed to recover in terms of on making sure. We had accounted for all the appropriate proportion of drugs.
We did find that because like was extensively highly metabolized.
However, because they go through a number of different routes that we don't have accumulation or buildup of what.
Classically term a major active metabolite I'd like to find it comes at the parlance is anything that would be 10%. The hires we have no individual metabolite that was that met that criteria, which essentially means we don't have to do additional follow up looking I heard possible filed with anyone particular type of that happily and so we haven't seen anything.
Indicate.
Anything other than the fashion vast majority if not all of the clinical activity of the drug comes from the parents TRASM on since it's not a situation like the case, but there's animals [laughter] <unk> have you know drug its ingested and then in fact most of the clinical activity comes from metabolites that themselves have varied.
PJ process.
Original pair it is not the case or the TRASM on we're very confident when extended half life of the drug how does that happen quite frankly, the past I could we have multiple metabolic pathways means that the likelihood.
Significant drug drug interaction is lowered and so we're really encouraged.
Oh and so they will.
They will not be any kind of late in the game changers. If you will in terms of a pick up the profile the compound as a move forward.
Oh, Yeah. This is probably let me just that just one more piece of color I think this is just further evidence of the decade.
Long research so we've done it read around GPCR targets.
As you know it Kosmotras is oh, the beginning of Oh family of compounds and that's one p. modulation, we haven't certainly again based on this decades long resource again homegrown product.
We understand exactly what we were going to see the human balance. We're really pleased we saw exactly what we expected and again. Unlike some of the competitive products, which are really academic compounds are two compounds. This is just talk a little stands on its own.
Okay, great. Thank you that's very helpful. And then my second question is often Etrasimod I was wondering if we could provide us some updates on the cultivate studying crohns disease.
Given that both U C N C D could be seen by similar physician.
Be able to elevate to leverage or olivine studies and lessons insights learn to expedite.
The company.
The person do you want picked up yeah sure I'm short answer is yes, we are establishing a global site network and you see.
The elevate program of approximately 450 sites.
And I'm going to cross over 40 countries and we will be leveraging many of those sites of the majority of those sites for the Crohns program. We may end up adding additional sites for Crohns eyes, you will know both you see and Crohns are very competitive and difficult to enroll and so we want to make sure that we're.
Sure Availing ourselves of every opportunity so we're likely overtime to develop that global network, even further for crohns disease, but there will be overlap in terms of the site and then in terms of how we go about Operationalizing site activity and the trial of all absolutely where we're developing a variety of.
Innovative approaches to a patient identification and enrollment at the site level and and intend to lever those.
Along with our two year old partner across into the Crohns disease program.
Okay, great. Thank you and then if I could just squeeze one more question I've a question about the patients are aiming to enroll in the advise trial could you provide some clarity on like baseline characteristics such as average EASI score absolutely be assessing a transmission in combination with <unk> with topical corticosteroids.
Yes. It in terms of course, there like the he will be in patients who have not how did that song topical steroids and so will not be used during that that treatment period.
Because they already have shot at it hasn't worked.
And then in terms of the you know it's basically the moderately to severely active atopic dermatitis is not modeled at this point and so we're not we're not that's really going into full inclusion exclusion criteria disclosure at this point, but its a fairly standard patient population in terms of the kinds of.
Patience you see enrolled in these programs across phase two and three.
Okay, great. Thank you that's it from us.
Our next question comes from Kennen Mackay from RBC capital markets. Your line is open.
Hi, This is Justin on for Ken Thanks for taking my question and congrats on the progress so far this quarter.
Was wondering if you could share with us to sort of feedback that you've been getting from the sites and that would be 52 trial, given your sort of tailored boots on the ground approach there.
And you know how that's impacted your thinking on B C D enrollment.
Yeah first new to take that again, yeah sure absolutely I get it reasonably early days, but we're really excited with the progress. We've made again, we're not gonna be sharing although on a call but called basis specifics around enrollment, but we are things are working.
The way we have a planned.
At this point and so and as I mentioned, there's always a shade kind of wrap up curve activities as you get sites on board.
And just that's just a point that harking back to my comments around clowns.
That's why we focus on operational seamless transition for phase two of the phase three for that for that program, but bottom line is that we're really encouraged we've seen today very encouraged with the amount of you know action, we have a sites again, a big philosophical aspect of our how would approaching that because we want.
To leave it alone.
The answer on the site relationships, we have established the field based game of health care professionals and ourselves our amazing last Saddam we'll get the.
Hi, principal investigator a level and that stuff, but you'll team of <unk> clinical trial educators and lack of a clinical study coordinator level. Another study stopped and so we're really doing a lot.
Makes that we own how we pockets insights and what would be to encourage them and help them and it's very much a customer focused kind of launch if you will approach to skew conducting a club. So we're excited as well it seems so far.
Great. Thank you very much.
Our next question comes from Alithia Young from Cantor Fitzgerald. Your line is open.
Hi, guys usually are funny <unk>. Thanks for taking our question and I have two I'm still first can you talk about we your expectations for us on March three Truenorth data, which is going to read out in the middle of next year.
Yeah, what do you think will be most relevant waste due to your own you see programs from both the clean coal and commercial perspective.
Yeah, Hi. This is I mean look let me take that to take a stab at that I think it's really difficult on two New York you get a good sense of where that's going to end up and I think it's one very important reason as you will recall.
Their end point is the three domain.
Bonafide mail score and excluding physician global assessment, and we never saw that data from their phase two trial. So so going back in time, it's really difficult to draw a line from their feet to the phase three so.
I think that's a question better ask them in terms of whats the read through from phase to the phase three.
What is their expectation what is there your underlying powering assumptions in the absence of that is it becomes very difficult to predict that outcome of the phase three trial or even to begin to guess, where it's going to end up.
Okay. So can talk a little bit off the potential risks do there.
I mean like why wouldn't you be like looking for from their data.
I mean, I well, we think the drug is effective in terms of its activity billings active.
Well gonna be looking at the safety profile and see that's consistent with what we've seen in their phase one phase two trials.
With with the easy conduction abnormalities out in time, so we'd be looking very carefully at their safety it hadn't put that out and they probably will report that out of top line. So we'll probably have to wait till they medical conference.
Assuming they got the powering assumptions right and indeed powered appropriately and had right inclusion you know we expect that we expect that to be a a drug to be active so outside of that it's anybody's guess simply because the they never showed us anything either phase two that would be to either.
Sorry.
Okay. Thanks, and then stop currently so keeping your strong balance sheet on went over 1 billion cash there. How are you thinking about deploying capital at this point is there anything you could do I'm too.
Celebrate car and timelines put more resources are you sort of more focused on creating a broader pipeline at this point.
I think from a from a strategic perspective, the things precedent talked about with not only the number of sites we have an elevated.
But the sites who have over overtime on elevate and cultivate a into phase three programs and all the underground resources I think we're already doing what you.
I had mentioned, which is we're focusing on enrollment, we're focusing on high and enrollment and we're bringing the resources where it matters.
In terms of our program. So that's kind of how we're thinking about it.
Okay. Thank you very much.
Thank you. Our next question comes from Jason Butler from JMP Securities. Your line is open.
We checked that your line is not on you.
Thank you and we will move onto our next question from Joel Beatty with Citi. Your line is open.
Hi, guys I'm sure you're going on for Joel. Thanks for taking my questions. I think most of mine had been a draft babies kinda two quick ones for ATP for one or for one eight fear filing your idea to fear the expectation that that'll be in the clinic next year and then as a brief follow up but I do have any timelines and why.
And she phase to advise trial will be up on clinical trials like us.
Personally I think those.
Yeah sure in terms of foreign aid answered, yes, probably ideally in the clinic next year I'm sorry for.
I'm going to Victor and then the Oh, I'm talking about Gov and filing for hosting for about half of your thoughts and shortly.
Great, except I guess.
Thank you.
Thank you enter next question comes from Jim Birchenough from Wells Fargo. Your line is open.
Hi, guys. Thanks for taking the questions and congrats on all the progress I guess first just on a topic dermatitis could you maybe go through the lines of evidence that give you confidence in that indication you mentioned biologic rationale as one of the drivers of where you go with the Transmark. So maybe if you could speak to the role of that's one p. modulation and in.
So quest ration of T.H. to cells or what are the different lines of evidence that really give you confidence that indication.
Pardon me personally my brother.
Yeah sure I. So there's a number of different lines of evidence obviously, we know that he its NFL, sorry that lymphocytes and you kind of films.
Our part of the general pathophysiology and that at a high level, it's more of a THQ profile and that's essentially what that's when P modulation impacts trafficking around both activated people to be positive T cells, and we're learning more about the units is going to fill aspect of this as well then very clear.
We do reduce teach to cytokine profile, it's all that kind of makes sense on paper.
When you actually look at pre clinical investigation I think all of it as an example has had a number of publications around animal models of wore a variety of dermatologic conditions models that those condition as we've taken a look at all of all of that work. We've also got early clinical results of our own in terms Uh huh.
TRASM odd.
With both pyoderma Gangrenosum, a very very brief exposure to some patients that we had initiated and then pull back on as a ultra.
Rare condition. Once we knew that we were going forward and I can be it didn't make as much sense to continue a form program in P.G., but when we did take a look at a handful of patients that have been treated and feel good results. We've also taken a look at a handful of Ah patients with Exim Tesoro manifestation of ulcerative colitis from from me Oasis.
Oh and feel we thought were reasonable that's all very anecdotal in terms of the clinical evidence with the TRASM odd.
Not a direct Israeli we've read out on a atopic dermatitis, but nothing in the mix here has a has given US reason to think that the overall mechanism of action of S&P modulation.
Combined with the path of biology of atopic dermatitis doesn't suggested we had a really good shot at showing some some clinical efficacy.
Great and then maybe just if I could squeeze in a question on all our or worn out.
Could you speak to what the hurdle is there how high hurdle or you're setting for yourselves is linzess kind of the the what you need to kind of approach or maybe maybe speak to what what so we should be looking for in terms of hurdle you're going to set there.
Yeah. This is I'm going to meet let me take that says you know linzess and the activity on Linzess had been around a two point change on the scale. They had about 50% of patients it's a 30% threshold.
And importantly, linzess is restricted idea c., so whats exciting years that weve activity potentially an idea C. N IBSD well, we can go after among a broader part of the marketplace and so we're seeing activity that's about to pull back from our piece to weigh data. So.
We think when we're in the ballpark, maybe little bit north of where.
The differences on the P.S. scaled and I think importantly would be able to go after multiple parts is disease person do you Wanna add any color.
Yeah, just just to point out it's a it's a classic phase to be dose ranging studies. This is exactly the point you would expect to be at right now the two way work wisdom classic phones. So there's been a sense different patient populations and idea. So we think that the underlying path the biology pain associated with question.
And I'd ask if in fact very similar Karen Preclinically. It is and so this is really a.
Attest to confirm that we've got good biologic activity the translates into efficacy and figure out exactly what goes can you do see I'm, having a good immaturity say the mouth and we think we'll see.
What we do now and and all that mention.
When you look at the Delta in terms of pain scores, albeit across different diseases quick [laughter].
Yes.
Dealt in pain scores, we saw was really significant clinically and so if we can show something like that and I've, yes, it's going to be really fantastic.
And then maybe just a follow up to that.
You're successful.
In a in the phase two work <unk>, what's the plan going forward is this something you'd look to partner.
Hi, how do you think about the commercial the best way to leverage this commercially.
You are you speaking about leveraging the Lord Abbott commercially yeah, yeah, yeah. So yes. So we look we'll we'll give the data will be the data. We're excited we think the biology spot honest Preston pointed out having another product that has applications potentially United yes.
See I B S D and importantly, I do you pain.
Puts us squarely in the G.I. Salesforce bad rentals, you know lot of companies that have launched their first drug and and part of the short the short the launch pieces because there's not much behind it you can't continually put put pressure in the marketplace for putting additional products and the therapeutic area we're not.
<unk> unique situation between the TRASM odd lore Nab we.
Yeah, we have the opportunity to have five different.
Gee, I indications and that sets us up really well for success long term so assuming the clinical trials pan out the way we hope they they do it really took a very nice picture for the company long term.
Great. Thanks for taking the questions yeah.
Thanks, Jim.
Thank you and our next question comes from Alan Carr from Needham Your line is open.
Thanks for taking my question.
Got it continue on Jim's a little bit there in terms of fun commercial strategy.
What is your.
Long term plan there in terms of U. S and X U.S. and the extent to which in my partner It and also I guess looking in earlier in your.
Pipeline what is the latest on your.
Efforts behind.
Your your cardiovascular dropped me to explore any are you working on anything, but but before that earlier stage and.
Let's start relationship with Beacon discovery still at times to them and expectations for them to deliver any drugs for in the future thing.
Great. Thanks, Alan Alan Your your first part of your question was that focus on Lorne ever just generally on corporate basis from a partnership.
TRASM Ananda.
Great. Thank you yeah. So our game plan right now is to retain you asking European right.
We don't have any intention of partnering out these markets.
We we think partnerships are highly value destructive long term to shareholders and most importantly, there.
They don't allow us to actually build a company we have a a generational opportunity here what did the combination of the team. We haven't played a the infrastructure. We built the quality of these fantastic aspects and of course balance sheet and we find ourselves in great position to really go off and build the company here.
And that's why that's our aim so.
And again I think we've got to write ingredients to do that and partnership is not the equation.
In terms of the long term pipeline and cardiovascular we've mentioned that we have additional cardiovascular targets in our pipeline and well prosecute those over time as our cost of capital continues to improve and and we continue to having a bandwidth to execute when things were very very.
Customs, making sure that we don't get too far ahead on area that then potentially impact our ability to execute on the LTV program called could be program et cetera, and the advice program. So.
This is about time and scale as we bring things forward well, we're in an incredible position to have a different compound sitting on our shelf today.
And we have access to sit and things like a beacon overtime as well so.
We have good relationship with Beacon they continue to be a contract research organization bras in a lot of bus I typically inquiry around our existing pipeline.
And we have certain limited right first refusal of certain areas of things that they're working on so we'll spend more time talking about beacon in the long term pipeline over time, but we really have no shortage of things to work on its really a it's really quite remarkable.
Hi, Thanks for taking my questions.
Thanks, Don.
Thank you and I am showing no further questions from our phone line and I'd like to turn the conference back over to on it Munshi for any closing remarks.
Great just wanted to thank everyone for being on the call today, we look forward to continue to update you on our progress.
We've got quite a few exciting things happening between this year and next year and look forward to continue the conversation thanks, everyone.
Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program you may all disconnect everyone have wonderful day.