Q2 2021 Arena Pharmaceuticals Inc Earnings Call
[music].
Good day, ladies and gentlemen, and welcome to the Arena Pharmaceuticals second quarter 2021 update at this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time, if anyone should require assistance during the conference. Please press star.
Zero on your Touchtone telephone I would the 1 that could turn the conference over to your host Patrick Malloy Vice President of Investor Relations. Thank you. Please go ahead.
Good afternoon, everyone and thank you for joining US today, we hope you had a chance to review the press release, we issued this afternoon announcing our Q2.2021 financial results and key program updates.
Joining me on today's call are Amit Munshi, President and Chief Executive Officer, Laurie Stelzer, Our executive Vice President and Chief Financial Officer, Doug <unk>, Our executive Vice President of research and development and joining us for the Q&A session will be our executive Vice President and Chief Commercial officer, Rob with psyche.
Before we begin I would like to remind you that we'll be making forward looking statements that involve risks and uncertainties about our goals expectations plans beliefs timing of the events or future results, including those risks and uncertainties related to our pipeline financial projections and the COVID-19 pandemic and its potential.
<unk> the impact business forward looking statements involve certain assumptions risks and uncertainties some of which may be beyond our control and could cause actual results to differ materially from these statements. A description of these risks can be found in our earnings press release, and our latest SEC disclosure documents all forward looking statements.
Based on information currently available to arena and we disclaim any obligation to update. These forward looking statements now I would like to turn the call over to Amit <unk> Amit.
Yes.
Thanks, Pat and thanks, everyone for jumping on today's call I presume everyone's had the chance to review the press release, we issued this afternoon, we announced some very important updates I'll provide some initial comments and then Doug will take you through the program updates in more detail and the advise open label data set and then I'll hand off of Laura to walk through the Q2 financial performance.
Following the prepared comments, we will spend the remaining time on Q&A.
Before we begin I'd like to formally introduce our newly appointed executive Vice President and head of research and development Dr. Doug.
Doug comes to arena with 25 years of executive leadership experience across clinical research and drug development with companies such as Dupont, Merck Glaxosmithkline and Bristol Myers Squibb. Most recently he was CEO of clay of Pharmaceuticals.
Does the extensive experience, including experience in immunology and in our therapeutic areas will be instrumental as we continue to transform into a sustainable global organization.
Turning to slide 3.
If you've been following the arena story of the course of the past year, you'll know the early 'twenty..1 we laid out 3 strategic principle is critical to our long term growth.
First we plan to selectively and prudently grow our pipeline of support our long term vision for the business.
Second we will continue to put all the pieces in place the store commercial commercial launch success.
Third we continue to advance the build out of our leadership team that will maintaining growth culture for success as you can see we're progressing forward on all 3 of these principles.
Turning now to slide 4.
Last week, which can important first step to bolster our mid stage pipeline within our core therapeutic areas with the announcement of the collaboration and option agreement with air stay of Therapeutics.
We are of high bar for in licensing and collaboration agreements and over the course of the past year, we evaluated all of the 200 potential deals.
The only few of these opportunities presented to us net of our essential criteria.
The first small molecule that we are well characterized the chemistry and pharmacology.
Second alignment within our current therapeutic areas of focus of the Gi dermatology in cardiology and 3 limited financial exposure of private program of investing.
The deal with <unk> checks all the boxes.
Risks or 72, 1 is an oral small molecule <unk> antagonist those originated by Astrazeneca with scorn category of income stream oncology.
As you can see from the slide risk for 71 enhances our early to mid stage clinical development pipeline with a phase <unk> ready assets in palm of plants, our posture of losses or PPP.
And an opportunity to explore risk or 700000 was potential in hidradenitis, suppurativa or Hs and IBD through a couple of small exploratory trials.
What is important to note that this is a fiscally sound deal structure will include the nominal upfront investment the grants us the option to acquire airspace in the library of CX <unk> 2 molecules based on the outcome of the phase <unk> study and the <unk>.
Putting trials.
Turning to slide 5.
In addition, the pipeline progress we made through the RSP acquisition I'm happy to share some important program updates.
As most of you are aware of we are studying of Transmogrify selective <unk> receptor modulator in 2 global phase III studies of ulcerative colitis.
As we announced in January of this year, we reached full enrollment of 52 week study elevate 52, that's the.
He remains on track the topline data readout in Q1 of 2010.
Today I'm extremely excited to know that our plasma of elevate 12.12 has reached full enrollment ahead of expectations.
And with that I'll hand, it off the Doug to provide additional details on the plasma and the.
The elevate trial as well as the other comments Doug.
Thank you, Amit and hi, everybody.
With regards to the UC 12 study, we anticipate the biologic naive to biologics exposed participant ratio will be 60% to 40%, which is consistent with the split we saw in the Oasis phase III UC study.
As many of you will do math of the timelines you will note that the UC 12 data will complete ahead of UC 52.
That in mind, we have developed a plan with the <unk> keep the database unlocked sequestered in the data blinded until both databases can be locked unblinded and analyze concurrently as specified in our statistical analysis plan.
I would like to thank the study participants the clinical investigators in the entire arena team for their extraordinary efforts that resulted in the study enrolling faster than anticipated.
As we've said previously we'll readout UC 12, and UC 52 datasets contemporaneously during the first quarter of 2022.
As many of you know we're also investigating of trials of mob in the ongoing phase 2.3 cultivate study in Crohn's disease, while we previously guided for a readout of sub study by the end of this year. We have made the decision to increase the sample size of 50 to 70 participants in order to enhance the veracity of this trial.
And these data.
We believe this additional data will provide a pool of datasets that will be commensurate with other open label trials conducted with competing products.
Importantly, this enhanced data may allow us to make sub study 1 into Registrational study and reduce the overall timeline for this program.
Additionally today.
We announced entering into a collaboration with second genome to identify microbiome biomarkers within the cultivate program.
Crohn's disease is marked by substantial heterogeneity of the potential to identify biomarkers associated with clinical response may be important to the ongoing design of the cultivate program.
With our target enrollment moving from 50 to 70 participants and the potential of impact from the COVID-19 Delta variance spreading across multiple countries in Europe, we are projecting that the topline data for subsidy able readout in Q2 of 2022.
Now turning our attention to the <unk> dermatology programs in 2020, we began of small phase II exploratory study in alopecia area of the investigating 2 milligrams of <unk> in participants with moderate to severe disease.
Today, we announced that we are broadening the participation. The participant population. The study to include a more moderate patient population and adding of 3 milligram treatment arm with the aim of detecting a dose response in study participants.
We believe that by taking the opportunity to execute this amendment now and should the day to be positive we will put ourselves in position to move directly to phase III.
With this protocol amendment, we now expect to readout of top line data in the second half of 2022.
And finally I am very excited to present, the recent data cut from the open label extension of our phase 2 advise study investigating <unk> in atopic dermatitis.
Can we turn to slide 6 please.
The data I'll be walking you through in a moment provide us with even greater confidence in the promise of the trust model for patient suffering from atopic dermatitis.
The open label extension program, followed the completion of the 12 week placebo controlled advised stubby period at a 4 week washout period.
At that point all of the participants who opted into the OLED, which was 85% of the advise study participants who completed the 12 week study.
<unk> 2 milligrams of of travel ban.
When looking at the 16 week data.
The OLED, we were pleased to see of consistent clinical improvement across key efficacy measures with no new no new safety signals to date through 56 weeks of follow up.
Let's move on to slide 7.
I'd like to point out that within each chart youll notice the dash lines across the board of which represents the placebo rates at week 12 of the advise study.
We have extended the placebo rates for the sake of taking a conservative view of the OLED data.
Also we've taken the the additional conservative approach when estimating the delta at the 16 week time point of the oily as we've applied a non responder imputation shown by the Blue line.
As you look across the the Iga easy 75 in peak pruritus Mris, you'll note the consistent clinical improvement across each of efficacy measure at week 16.
Further we have 16 of the OLED, we observed the Iga improvement of 47%.
As a reminder of the Iga is the FDA registrational endpoint for phase III studies in atopic dermatitis.
When looking at <unk> 75, we observed an improvement of 72% of peak pruritus change of 61%.
As you will note that with the appropriate caveat to both the cross study comparisons.
The data is in the range of approved biologics in a day.
As of the relative Delta with placebo rates extrapolate from the initial 12 week period.
You can imagine we are very enthusiastic about these data.
While we're still in discussions with regulatory authorities around the world to establish the final phase III study design and protocol based on the early data presented today along with the review of the full dataset. We've made the decision to anchor our phase III program to of 2 milligram dose.
With regards to the timing, we anticipate commencing phase III study activities in Q4 of 2021.
Now I'll turn it back to Amit to highlight our upcoming catalysts Amit.
Yeah.
Thanks, Doug you put kind of slide 8 please.
With the update we presented today you can see the next 12 to 18 months, we both busy and exciting.
Looking at Q1 'twenty 2 we will have data from the UC 12, and UC 52, contemporaneously, followed by the enhanced and expanded cultivate sub study.
In the back half of 2022 of our plan is to submit our NDA for cloud of minus of colitis and positive data.
We continue to work diligently across the organization as part of our NDA and the ongoing work in areas such as clinical oncology.
CMC quality and regulatory.
Also in the second half of 'twenty, 2 we will turn over several important data readouts, including <unk> margin alopecia, Areata with 2 and 3 milligrams and the extended patient population.
And the focus off of guidance or Eo.
And data from Apd for O&M command girl in their respective cardiovascular indications.
Now I'll hand, the call over to Lori, who will take you through the Q2 financial performance.
Thank you Amit.
Turning to slide 9 for key financial measures.
Search and development expenses for the second quarter totaled $112.5 million.
Compared to $64.9 million interest.
Same period in 2020.
This increase was primarily driven by advancement of our clinical trial programs as well as an increase in personnel expenses as we staff to support our program growth.
Selling general and administrative expenses for the second quarter total 31.9 million.
Third to $22.9 million in the same period in 2020.
Net loss for the second quarter was $146.1 million.
Compared to the net loss of $84.9 million for the same period in the prior year.
Basic and diluted net loss per share for the second quarter with $2 and <unk> <unk>.
Compared to the basic and diluted net loss per share of $1.61 for the same period in 2020.
Operating cash burn in the second quarter was $93.8 million compared to $77.8 million in the same period in the prior year.
And as of June 32021, cash cash equivalents and marketable securities were approximately 1.0 billion.
Third the $1.1 billion at March 31, 2020 of mine.
Now I will turn the call back over to Amit, who will make some concluding remarks before opening the call to the Q&A session.
Thank you Laurie we go to slide 10 please.
And looking at Q2 performance you can see we made continuous we continued to make significant progress across our entire portfolio and then now we have a direct line of sight towards.
Phase III elevate data readout.
Overall for the portfolio, we continue to evaluate the market.
<unk> and regulatory environment, and where necessary adapt our approach of speeds of our science, the best chance of providing a clear clinical signal.
On the atopic dermatitis, we continue to make strong progress in the open label data extension that we presented today gives us confidence in entering our phase III program.
And of course finally, we continued to maintain the strong cash position.
I'd like to take the opportunity to thank the entire arena team for the hard work and dedication.
As we continue to build towards the future of the company.
With that operator, let's move to Q&A.
Thank you, Sir ladies and gentlemen, if you have a question at this time. Please press the star and then the number of 1 key on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.
Your first question is from the line of ODP of young from Cantor Fitzgerald. Your line is open.
Hey, guys. Thanks for taking my question and congrats on the the progress with enrollment in just 2 for me 1 of the alopecia already out of the study I just wondered if he's the only thing in the 2 Meg the kind of informing the decision the kind of move into the 3 mix or any color. There would be helpful. And then as you think about the completion of the enrollment of.
Do you think that.
Are there are there things in consideration of the trials and then kind of enrolling during the Covid that you guys have proactively been doing especially in light of some of the learning maybe from the topics and just wanted to get some color on that thank you.
Sure, let me start and I'll, if I Miss anything debt. Please please jump in on the AA study were blinded to the data so.
It's not a reflection of the 2 milligram.
As you know in atopic Derm, we did not get the chance to explore the 3 milligram of the safety studies. So we thought this was the.
The right place and time to take a look at 3 milligrams importantly, and just as important of the 2 to 3 milligrams of expanding the patient population in the study and then the final point, which I'll Echo what Doug said in his prepared remarks is that by increasing the study and making it more robust we're moving the study from a proof of concept study to study.
That could potentially take us directly the phase III. So the overall program timeline gets the.
Potentially diminished by doing that so that's really the the purpose of that the change that study.
Those of the enrollment.
On a trans of Mod and ulcerative colitis.
As you know we've maintained the very high degree of touch in the trial.
We continue to evaluate every patient every day every data entry too.
To ensure that.
That we of the strongest possible integrity of the trial.
As I pointed out previously discontinuation rates.
And other interruptions of dosing et cetera, well below our pre planned statistical expectations for the use of studies. So we continue to be very positive about where that trials heading both in terms of the timelines as well as in terms of the data integrity.
That's great. Thank you very much.
Your next question is from the line of me now the retail Garg from Citibank. Your line is open.
Hi, this is neena on for Neenah.
Had a quick question about the elevate UC 12 study.
How long will it take for the analysis from the elevate UC 12 will it take a full inc. Post the last patient visit the airport that topline data. Thank you.
Jim.
Yes so.
Doug pointed out.
Yes.
We will do the math and the trial timing may look earlier than UC 52. The data are intended to be an analyzed together.
So the the end of the study we would expect the normal time period in terms of analysis.
But it also important to remember that the the last patient out is really dependent on whether patients most of the OLED or not so well.
We will know more about exactly how tight the timing is between the 2 studies as we get towards the end of the end.
And the patient exposure and we get the last piece of Adam the studies so.
Stay tuned we're excited about where we're at with this and.
Really pleased that the teams were able to exit.
To execute on UC 12.
In the middle of the Covid pandemic. Thanks for your question.
Your next question is from the line of Chris Howerton from Jefferies. Your line is open.
Fantastic. Thanks, so much for taking the questions and feel very excited for the UC data too so.
So I guess, maybe the question for me primarily is around what is the design of the cultivate study I'm feeling a little confused around the sub study a what sub study 1 is and kind of how you see that becoming.
Potentially registration of and if you are willing to take a follow up question for me.
So I'm curious what the status is of the.
The extended release formulation is for your <unk> you.
Have more clinical programs going on of more dose selection going on how does that layer into your thinking.
Yes, thanks for the question the.
The design of the cultivate study starts.
It starts with sub study a as you know that's the.
<unk> does not have of placebo control.
And just 1.2 and 3 milligrams by expanding that study the 70 patients.
We were able to get a pool data set that's comparable to compete of competitive products and done the open label studies the move directly onto Registrational trials. So it really gives us the same sized dataset.
Of the robustness and on top of that we've got the collaborations on the biomarker side, which will help inform the the overall program in time. The sub study of 1 was designed to the dose finding study of <unk> 3 milligrams.
In the placebo controlled setting.
At this point should the sub study readout in line with our expectations.
We would be in a position to power of sub study 1 to be the first 2 pivotal trial. So previously we had contemplated sub study 1 being the dose finding study and then moving to 2 large phase III trials.
In this case would be able to power the.
The sub study 1 of if that makes sense.
Thanks, Amit.
And then the second question on the ER formulation.
We continue to make good progress across the extended release as you know we've done some initial work on the.
On liquid formulations to really try to pinpoint the exact curve we wanted to generate.
And now what we're doing is we're looking cross <unk> 3 milligram and looking at broad range of potential formulations to begin the mimic.
That initial curve. So that work is ongoing and it's an iterative process and we look at we look at multiple different formulation methods and Theres, a concentric circle between concentric circles between being able to to really identify the right formulation and developing new intellectual property. So.
As we've said before the the <unk>.
All of the extended release as the both extend and expand the role of the <unk> extend the intellectual property life and be able to expand into new indications and so that work is ongoing.
System of what we said before.
We hope to bridge that into the.
The dermatology programs over time.
Okay, that's cool thanks, Amit.
Thank you.
Your next question is from the line of Jessica Fye from Jpmorgan. Your line is open.
Hey, guys. Good afternoon, Thanks for taking my question.
I guess first given what's become a bit of an extended timeline for subsidies.
Can you comment on where enrollment stands in the study just to give us the kind of a little progress update.
How closer you T. Originally planned 50 patients.
Sure. So we don't comment on details of any studies enrollment.
We are spot on where we expect to be on that study.
The with Doug's arrival, and taking a look at the competitive set evaluating our regulatory potential path forward. We've made this change so that we can begin to move the overall program faster forward. So that's really the the of.
Objective here.
Okay. So was it does the arrival of its the reason why.
Just happening now that you are deciding to enroll 70 patients and this wasn't a call you were able to make earlier.
We were working on this earlier and working through regulatory implications.
As you know the working through regulatory implications isn't the fastest processing of the world. So we are already working through this priority of Doug's arrival.
Doug's judgment here.
The extremely important with the broad range of expertise.
<unk> really gave us confidence debt that we were making the right decision here.
Great and just last 1 for me do you see pooled.
Safety data from subsidiary on the.
Basis, maybe on a blinded basis.
And given that the 3 milligram as you know it.
It would be part of that pool of data.
Anything you can comment on on safety so far.
Sure. So the safety is evaluated.
Blinded fashion by.
Bye bye external parties.
And the Smbs and we haven't seen anything that would make US a question of our decision to go from 2 to 3 milligrams at this point.
Great. Thank you.
Thanks, guys.
Your next question is from the line of Chris Shade with Tony from Goldman Sachs. Your line is open.
Great. Thank you very much of 2 questions 1 on the current cultivate study.
Could you help us a little bit understand the.
Patient characteristics background in the way that you have helped us to understand the UC program and to get a sense of whether any of the modification in the enrollment from 50 to 70 patients. There is taking any features of patient exposure to biologics into account.
Yeah, Hey, great. Thanks.
Yes.
No real difference in the additional 20 or so patients that we'll be adding to the study.
The original 50, as you know working moderate to severe crohn's.
There's some very clear day.
Find guy.
Guidance guidelines in terms of.
Of the patients we went in in that study and it's consistent with what everyone else. The study May I think this is the challenge in Crohn's broadly which is.
It's a narrow subset crohn's as you know has a lot of heterogeneity as Doug pointed out.
The studies are all designed to evaluate a very narrow subset of patients.
Consistent with what other competitive products have seen so.
Doug Rob anything to add to that.
This is Doug only to say that we've kept the inclusion criteria as as we've just expanded the sample size. So we havent more veracity with the with the data set of which where you basically are decisions, but the hope would be that we can be bullish in terms of the next phase of experiment of even the experimentation.
Got it and then the follow up would be on advise in atopic dermatitis, you gave us the snapshot of a look that you did in July I think previously you've said that you'd be doing a more full of presentation of the data sometime in the back half of this year should we still anticipate that and roughly when that would be helpful to get insight.
Yes, so the data that we presented today.
The relatively fulsome set and we will continue to evaluate the open label data over time, we expect to present this data.
In the coming medical conference and we're working through that now so.
This will get presented.
In a in the.
<unk> Forum.
But as I think you can see from the data.
It gives us additional confidence that the outcomes that we're seeing here even with the elevated.
The <unk> rates, we saw in the first of all week are actually quite robust and in line with other agents.
Again, consistent with the safety profile of the <unk> being a once a day oral non.
Not having the liabilities of the JAK inhibitors.
And being able to deliver efficacy that's in the range of the.
The approved biologics.
We're incredibly excited about where this is where this is heading in.
There is the substantial market opportunity in front of us.
And just to be clear the word anchor on Cumulus grams does that mean, the 3 milligrams is not part of the go forward plan or is it does not.
Yes, so it's not part of the phase III plan Thats correct.
Great. Thank you.
Thank you.
Your next question is from the line of Joseph Schwartz from SBB Leerink. Your line is open.
Thanks, very much maybe I'll ask about your new collaboration with second genome to analyze patient responses and cultivate.
What's the null hypothesis there is it that patients who are more despite all of that kind of force responses to the try as a mud or need higher doses of what do you do with the findings that you uncover will you report them along with the.
Topline cultivate data.
Would you expect to enrich enrollment in phase III, just talk a little bit more about.
Your plans there.
Sure Justin Let me start and then the paint ended off the dock.
The reason to do this is really the heterogeneity of the Doug pointed out and to the extent, we can begin to really understand the impact of the Trans mountain, we've talked to extensively before about.
<unk> well beyond just the.
The migration of T lymphocytes.
We've talked about activity on social junction proteins, we've talked about activity on the innate immune system.
And so we're really excited to see.
These biomarkers come out the do you want to lend some more color on that.
Just to say that.
You all know the display ecosystem is an important feature here I think there is not of lot of literature on the quantification of display assets. So we're not going in with an app priority notion of of.
That's going to turn up other than we will do exploratory studies to see if there is a cut point in terms of the response rates that might predispose US then to stratify or enrich in the phase III program.
Having done work in the Crone space.
A lot it is an extremely difficult population to homogenize. So if we can find any biomarkers that could help too.
Predict who's going to respond better I think it's kind of the significant enhance the likelihood of success in phase III.
Okay. Thanks, and then.
Can I just ask about your dose selection and how youre thinking about dose selection for phase III in atopic derm.
It sounds like you are.
The settling on 2 mixes of the high dose is that right.
Can you give us some.
Some of your thoughts around.
Where.
Is to just to really seemed like the top end of the dose response curve. It seems like at first you thought that and then you were.
Considering going higher so if you could just give us an update on your latest thoughts there that'd be great.
Sure. So let me answer that question by hanging up the road to talk about.
The data, we presented today and how it stacks up competitively.
And while we're excited to anchor the phase III program on 2 milligram, Rob can you shed a little bit of color on what the numbers look like relative to the competitive set.
Yeah, Thanks, Amit I'll be happy to good afternoon, everyone. It's a pleasure to join you.
When we looked at the open label extension data, we're able to compare that to all of the approved drugs and the drugs that are currently in phase II phase III.
In contrast, microbiome up at the biomarker versus microbiome as a treatment massage the mortality for I V D.
Yeah, Let me, let me hand that off the dog.
Okay.
So sorry.
Thank you for the question. So we're open minded so.
Look first and foremost at the impact of our treatment on on just biosys in the Crohn's disease setting, but also look to see what the baseline just biosys status was in to see whether or not there's indicators of individuals who actually have better improvement than others in terms of their crohn's disease symptomatology.
Yeah, and can I just add 1 the 1 more thing which is.
We're not discussing.
Humans against the microbiome, we're just looking at Biomarkers in the microbiome as it relates to ask 1 P modulation of we think of.
The Dude's point, if we can create more homogeneity in the patient population that combined with the larger dataset allows to be far more expeditious and and fiscally prudent in designing the the remainder of the program.
And serious if you're able to find a friend in town of South what patients of Pat respond to your therapy, Elvis by the <unk> better as an opportunity for your chair of the side of the mall robot file perhaps at the smaller date of staff because you're enriching.
Certain population to have more likely to respond just curious you know anything about the E.
Okay before the or re report that kind of 2 milligrams of of <unk>. So it's from that perspective, it's it's a it's a.
Queen of ways you can look at an open label study to look at the effect size for a <unk> at 16, you can see at 15 weeks you can see again of very robust response.
Awesome. Thanks, so much for all the color. Thank you. Thanks to you I appreciate it.
Your next question comes from the line of Joseph Turner from meeting your line is that the.
Hi, everyone. Thanks for taking the question going back to the all of a piece of the trial, you're adding the higher the remake those here just curious if you could <unk>.
Expand a little bit.
Sort of the expanded patient population.
Type of debt.
How should we think about that is that based on potentially.
Potentially disease severity of baseline total scores and is that <unk>.
Expanding into of additional subtypes here that stratified across both the 2 Megan the 3 make.
Arms. Thank you.
Yeah. So yeah, we would satisfy the 2 to 3 mile lamps. The the idea of heaters to give more L. P share are you out of patient that's supposed to compel us the name of ourselves patients. So we could address the broader subset uhm recall also the we're treating for 24 weeks in the study and we're talking about resident team of besides being so.
The the toxic of the hair follicle, so uhm, the having sufficient time to be able to to make an impact here has the has anything to do with being able to have that 24 week treatment period. So uhm 2 yes, we're we're looking at between 3 milligrams and and expanding more to alopecia or.
Ghana as opposed to tell tell us the name of your house patient. So we'll get a broader subset of patients and based on that we thank the the expanded set here will allow us to to to make a more informed decision about how to free.
Free.
And are just just the.
So we're going down to of Salt score of entry of 25 or more of a 45 to 95 up from 55.
And at the end of the day with the added enrollment we should have an even split between placebo 2 milligrams of your photographs of approximately 26 of 27 patients for them.
Great. Thanks for taking the question.
Thank you.
Yeah sure my skin.
Your next question comes from the line of yet piece of furniture from Guggenheim Partners and the line is that the.
Hey, guys. Thank you for taking my question just the 2 for me first on cultivate Substudy did you take a look at or what day of any analysis of the day. The that led you to increase the sample size or are you. Just increased is based on you know like without looking at the data.
So that's the first question.
Yeah, we were blinded to the data. So we made this decision based on having the data.
Allow us to to really think about sub studying what is the pivotal study that was the driver where again, we're blinded the the data.
Okay.
And then with regard to the U C..12 can you talk about how the patient mix might be looking between the biologic not even expose patient and how would that compare to 52.
Sort of 52, we announced 70.30 split this is premium closer to what we saw in ways, which is about a 60.40 split.
No you've gotta bioethics.
Got it and just to confirm you will be analyzing these data sets together both of you see trial, even though that's on the most likely will be sort of done before 52.
Yeah do you want to just expand on that.
Yeah, so there'll be there'll be analyzed contemporaneously, so that would do it the same types of the plane of would be the actually keep the date of the database Ah unlocked for you see 12.
Until the time, where approximately when we're gonna lock the database of you see 52 in the run the analyses on each of the studies at the same time of then subsequently do pool of analysis as will be needed for the ISS of the icy of the of day submission to the rest of it to you.
Oh, Okay helpful. Just 1 final question, maybe on the expensive side could you give an update on how the expenses of in a ramp up for the second hour for the rest of the of and maybe in 2022.
The way do you want to get that.
Yeah certainly.
We haven't given guidance for 21 of our 22, yet on the cash burn, but what I can tell you is we did have a 214 million dollar cash burn it in the first half of 21, and then obviously, we have the increasing uhm patient enrollment in all of our studies in the advancement and all of our studies. So we were.
I'd expect some rap.
Got it thank you so much.
Your next day. Thank you you have been.
Your next question comes from the line of per car I'll go along from Jones trading your line is open.
Hi, Thanks for taking my question. My first question of as on the <unk> <unk> just wanted to clarify if there are any other changes in the free free trial.
That we should expect compared to advice.
To minimize the placebo hi, fluffy with it that you saw in the face to secondhand tomorrow non commercial you know of conversations with the cable suggest that tickles, the Bristol Myers M B.
The recently launched has been limited too frequent refractory you see patient I know, there's still the long way to go but just wondering if you had any thoughts on the implications. So that was the uptake and their pricing and you see 2 how you are thinking about y'all commercialization strategy. Thank you.
Sure. So the me, let's start with the commercialization question, Rob do you want to pick that.
Yeah, I'm happy to thanks. It. It's it's early the approval was May 27. So we're looking at just a few weeks of data where they've been in market. The relative access within the market is pretty limited. So right now for most payers are limited behind other agents.
Think of another consideration is the price stands out of it and the you see market. It's 90000 per year, that's much higher than compared to the hits a competitive choices and another therapies. The other piece 2 is that there is 1 of the key differences between the work that they did in the work that we're doing is to try to <unk>.
Generate and demonstrate value for the molecule for payers prior to launch that's the Gladiator study. So my assumption with these are engaged with payers right now and they're negotiating so they're they're access of very limited to the small group of patients, which is why you liked the hearing that who OLS.
I'm sorry can you repeat the first part of the question again.
Yeah on the on the phase 3.8 of them crowd any other try the design changes compared to advice that'd be can expect.
Yeah. So what we've said in the day 3 program is we have a substantial amount of moderate patient.
In the face to study and we'll be looking for more of of contemporary.
Split between moderate or severe atopic turned patients closer to 50.50 of your call. We were thinking 83 per cent moderate at baseline. So we're looking for more moderate to severe patience and there'll be a much more.
The temporary split in the monarchs of your population.
Thank you.
Great. Thank you.
Your next question comes from the line of David Pong from M. S. N B C airline is open.
Hey, Thanks, so much of the update and taking the question. So I've got a couple of.
Can you talk a little bit about the the Gladiator you can study and moderate patients uhm. So you know what the status of that you of any any relevant updates for that 1 and and uhm are there is there a timeline towards the top of mind data.
Sure for Gladiator of that studies, and rolling and we expect to have topline day. That's a pair of your approval studies can we expect to have top line data. Shortly after the approval as Rob pointed out to really work with the payers on that what's that date of Sam.
So to really drive to drive the greater per access. So it's it's still without the study of moving now.
Okay, Alright, Thanks, and then the quickly I know you know both of come out of its on the few different ways, but I I kind of wanted to ask the question in terms of a topic. The base 3 you know it sounds like you're pretty confident in 2 milligram dose, but as you you know as you seem more 3 milligram.
Date of them close and Alocasia area of that is that is it possible that kind of influence is your thinking and you know you may be open to any type of protocol Amendment free food free milligram arm or you know again as it is 2 milligrams a day with that you know, we all really should be looking at here.
Yeah. So for the face of the program. It's 2 milligrams Uhm, we reserve the right to go back and look at 3 milligrams and the separate set of study.
The M C work that could become rate limiting to an NDA submission.
Yeah did you want to take the first part of that and I'll take the second 1.
Sorry could you repeat the first of all again.
The tissue.
Have you have you ruled out the the <unk> has the direct impact on the microbiome.
Because if you are looking at what the indirect day.
An impact on the microbiome of treatment would be as you.
Just ruled out that you don't have the baseline effect directly in the gut.
So we believe from our preclinical models that we do not but that's 1 of the things that will be of exploring more intensely in the in the human studies with the the the collaboration that we've just announced with the second Gina.
Yeah.
Great.
Okay and then the second part of looking past the you see studies, there's nothing right in the meeting we've been working for a little over.
A year on making sure the claim form and quality system, the necessary as well as the the C. M. T E. R. R. All in place the towards the end of the says nothing late in the morning beyond the yeah. The.
I'm getting the study is completed.
Okay, great. Thanks for taking the question.
Your next question is from the line of Kenya, K from RBC capital markets airline is that day.
Hey, Thanks for the screen in in Great to hear about the the if you're 12 recruitment completion big Congrats there dark maybe another question on that 2 milligram gross and a day just wondering what the drivers were behind that decision to move forward without the bat. The converge verses 1 milligram over time are really sort of again, let the.
Driver was there separately just thinking about the free milligram dose in alopecia Areata are there any disease etiologies of or biology, there the dictate that higher dose or is that sort of just the result of of following the data.
And looking forward to that you feel better thank you.
Thanks, and thanks for the question.
So yeah, we feel very comfortable with the 2 milligram dose in in the larger populations in which we're currently testing and most importantly, all of the work that we're doing and you see we have margin we feel there. There's there's reason to probe 3 milligrams in more of refractory diseases like Crohn's in alopecia Arietta and we'll see.
What those results show both in terms of efficacy and takes you make the right decision terms of dosing moving forward or for those indications and as Amit already say that you know you never say never so if in fact, we see that the 3 milligrams and select indications of is and safe and more effective and we think the villa in Italy for us to progress and diseases like the topic there.
The tightest and by the way the regulatory agencies have a lot to say about that then we'll proceed in consultation with that.
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[noise] I'm shouting no further questions at this time I would not let the kind of conference backing Amit mention.
Great. Thank you everybody for being on the call today and.
And you see we continue to make significant progress across the portfolio. Overall, we continue to do value, Inc market competitive and regulatory environment.
It is necessary the adapter approaches T to shorten the overall timelines for programs and get really are signs of the best chance of providing how can I go ahead, and that's really important to us and we think the changes we continue to make on the studies of all designed to really accelerate the overall programs. We're excited about anchoring on 2 milk.
So the topic darn given the the 16 week day he'll be presented today and I'd like to just conclude again by thinking of the arena team put the incredible hard work and dedication of across the portfolio uhm, but specifically call out the the end of a team and arena for being able to really face of a lot of.
A lot of external N noise around the pandemic being able to execute the study in a way that's the head of schedule as well as maintaining strict data integrity. So thank you again for having the jumping around the call and look forward to continued conversations.
Ladies and gentlemen, today's conference. Thank you for your participation have a wonderful day you mean the.
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