Q3 2021 Landos Biopharma Inc Earnings Call

Welcome to the landowner Biopharma corporate update conference call.

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I'd now like to turn the conference over to Becky Mosaic director of administration and operations Atlanta Becky. Please go ahead.

Good morning, everyone. Thank you for joining us today with me on the call today are Chris Garabedian landowners, who is newly appointed chairman of the board, Tim Ablin interim President and CEO and Patricia Bitar, our interim CFO.

We will take your questions after comments by Chris and Tim Please.

Please be aware that all statements in our prepared remarks and in response to your questions other than those of historical facts, including statements regarding our future results of operations and financial condition business strategy and plans and objectives of management or future operations are forward looking statements within the.

Meaning of the private Securities Litigation Reform Act of 1995, all such forward looking statements are inherently subject to risks uncertainties and assumptions and are not guarantees of performance and are expressly qualified in their entirety by cautionary statements.

The forward looking statements made.

Or as of today's date, and we undertake no obligation to update them to reflect events or circumstances after today or to reflect new information actual results revise expectations or the occurrence of unanticipated events, except for as required by law, we may not actually achieve the plans intentions or expectations to close in our forward looking statements.

And you should not place undue reliance upon our forward looking statements for more details. Please refer to our earnings press release and to the risk factors in our other SEC filings, particularly the risk factors in our annual report on Form 10-K, and subsequent quarterly reports on Form 10-Q with that ill turn it over to Chris.

Good morning, everyone. Thank you for joining us.

Today, we'll be providing a corporate update and discussing our renewed focus on advancing our promising clinical stage programs to ensure we have the optimal advanced development strategy to ensure a successful path to commercialization for our products, we will share our vision for the company one that will see lando sharpen its focus.

And prioritize the most important product development activities to maximize both near term and long term value for patients and our shareholders.

Any of you know we issued a press release last Monday announcing a leadership transition.

Joseph Boston Garden, Yuri era, founder Blando stepped down as chairman and CEO and has agreed to serve as an advisor to the company.

I have personally been actively involved with landa since our founding.

I'm honored to be serving as chairman.

<unk> been a fellow board member and highly experienced industry executive and former public company biotech CEO has agreed to lead the company as interim President and CEO. During this important time, while the board conducts its search for land doses next leader as permanent CEO.

Italy, Patricia guitar, who is also on our call today was appointed interim CFO.

Before I continue I'd like to thank Joseph for his leadership and vision in founding in creating a truly innovative company with a science driven entrepreneurial culture that has set the company up for a promising future.

His vision for the Lando scientific platform that helped create an incredibly robust pipeline with three clinical stage product candidates and for additional preclinical assets across three novel mechanisms of action all with unique drug like characteristics for the potential treatment of autoimmune and other immune.

Mediated inflammatory diseases.

We appreciate his continued support as an advisor and shareholder.

With seven product candidates in the pipeline across three novel mechanisms numerous potential disease indication.

Joseph and the board agreed that it was the right time to transition to our next phase of leadership and to identify a CEO with experience managing multiple clinical programs, a promising research platform and domain expertise in the disease categories, and which lando compete.

As the board executes this search we're fortunate to have a leader of tims calibrate the helm, Tim is a seasoned veteran in the industry and since joining our board. He's played a valuable role in helping land us navigate the market as a publicly traded company under Ken's agreement to assume the interim leadership position, we believe land us will continue to be.

Ducting and advancing their research programs and be better prepared to position the company for future success, while we search for the best permanent CEO for the company.

With that I'd like to provide a brief overview of our thoughts and perspective on how foreign Lynda Com and how we plan to best position the company for success in the coming months and years.

Then I'll turn it over to Tim to provide additional detail on our research activities and additional plans to help refocus and re prioritize the company's current efforts.

Over the last four years Landers has transformed itself from a small organization with a single preclinical product candidate now known as all Milan Court.

Two a clinical stage company with one of the most promising portfolios in the immune mediated inflammatory disease field.

During that time, we've achieved several important milestones, including having completed.

Phase two clinical study of all Milan court in ulcerative colitis with encouraging results pre.

Preclinical testing and I M D and completion of the phase one safety dosing PK study of <unk> in healthy volunteers, enabling lenders to enter a phase <unk> study in ulcerative colitis patients that is currently enrolling.

And preclinical testing in an IMD for L. A b P. One O four enabling language to enter phase one safety dosing PK trials in healthy volunteers that is also currently enrolling.

And finally preclinical testing on for additional product candidates, including <unk> 69, which represents the third distinct mechanism of action for the land portfolio.

As you can see lenders has established itself as an incredible productive research engine.

With a pipeline of numerous novel product candidates targeting unmet needs in these immune mediated inflammatory disease areas. We are confident land dose is well positioned to drive success and value for many years to come.

As a result of this productive research engine that has produced such an abundant portfolio landowner is at an important inflection point, which requires an intense focus on the optimal advanced development strategy.

This includes thoughtful consideration of our future clinical strategy and trial designs for each program. This includes determining the appropriate in rich patient populations for each study and indications. These are defined by the careful consideration of inclusion exclusion criteria. Good clinical trial design also includes.

Determining the optimal clinical endpoint, the powering assumptions and the regulatory strategy that will drive the most successful and expedited path to commercialization.

So this guy and I'm pleased to announce today that we are refocusing and re prioritizing Lantus is research and development activities and providing revised guidance for the development of our three clinical stage products.

While the company has communicated many possibilities for additional preclinical products in additional disease indications in which <unk> can be pursued we will be prioritizing the product portfolio and really doing the focus of the company on a relatively narrow set of indications, including all Milan court, which targets the land sell tea.

Just wait for the gut restricted treatment of patients with ulcerative colitis, and Crohn's disease, and he often I felt like Oesophagitis or E. L F.

Annex 13, which targets the <unk> XR one pathway for the gut restricted treatment of patients also with ulcerative colitis and Crohn's disease, which also has the promise as a complementary indoor combinatorial approach alongside all Milan Court.

Finally, L. A b P. One O four our third product in the clinic, which also targets the landfill two pathway, but with more diffuse systemic exposure and activity for the treatment of patients with lupus and rheumatoid arthritis.

We are confident that enhancing our focus on advancing these three highly promising novel assets with the right development strategy program design and optimize clinical trials will drive the greatest value for our company and its shareholders.

Importantly, I want to emphasize that our mission at <unk> remains the same.

We remain committed as ever to discovering and developing novel oral small molecule therapeutics for patients with indications and the immune metabolic and immune inflammatory disease space.

Now I'd like to turn the call over to Tim to provide a further update on Lantus is near term clinical plans and other research and corporate activities.

Yeah.

Thank you Chris.

First like Chris I wanted to acknowledge what a great honor it is for me.

To serve in my case, as interim President and CEO Orlando's to.

To tell you a little bit about myself I have more than two decades of leadership experience in the development and approval of innovative therapies I have long viewed land dose as a particularly innovative company in our industry and since joining the board in May I've gained an even deeper appreciation for the important role we have in developing first in class.

Oral therapeutics that will address the unmet needs of patients with immune mediated inflammatory diseases.

Over the last few days I've been onsite in Blacksburg and have witnessed firsthand the passion the dedication of our talented team. It's an exciting time at land dose and we're looking forward to continuing our momentum as we build on the strong foundation of the clinical stage programs.

So let me talk now more specifically about each of the clinical stage programs that we're focused on advancing first.

For <unk> in ulcerative colitis, we plan to leverage the learnings from the initial phase II study, including a number of compelling post hoc analyses from our research team.

To design and run a robust phase II study.

While results from the phase II study in mild to moderate UC patients were encouraging.

We firmly believe that the right drug development decision and the right clinical strategy for <unk> core for the long term and ulcerative colitis will require building on this data in phase two b to gain additional perspective on the optimal dose.

The most enriched patient population the powering assumptions and other considerations to inform a pivotal phase III program and support regulatory approvals.

We're going to take a very close look at these variables and we'll be working with our outside consultants and advisors, including our clinical advisory board in the coming weeks to complete those plans.

And we expect to be in a position to communicate uptake updates early next year.

Okay.

Next let me speak to the four active clinical studies that we have ongoing a.

Our phase II study of OMA land core in Crohn's disease patients a 40 patient single site mechanistic study of <unk> in Crohn's disease patients led by prominent investigators at Mount Sinai and co sponsored by NIH.

Phase <unk> dose ranging study of Nx 13, and all sorts of colitis patients and a phase one safety dosing PK study of L. E. D T. One O four in healthy volunteers.

So first I want to say, we're very pleased with the progress in each of these studies.

The studies continue to enroll subjects and are proceeding as planned that said.

Going forward.

We won't continue the previous practice of guiding on the timing for top line clinical study results.

We're also actively evaluating the sample size of the phase II study of <unk> in Crohn's disease, and the phase <unk> study of annex 13 in ulcerative colitis to ensure landowner optimizes the powering of our data for these studies.

Next I'd like to speak about the research efforts at land dose are promising preclinical pipeline and the opportunity for expanded indications across the entire product portfolio.

Many of you know our AI driven proprietary research platform also known as Lance.

He has successfully identified new multimodal pathways at the intersection of immunity and metabolism.

Resulting in a robust pipeline of I N D candidates with unique product profiles.

As Chris mentioned, given our renewed focus on the optimal development strategy for our clinical stage product candidates. We believe this is a good opportunity to conduct a strategic review of the preclinical programs.

And this is going to focus on the optimal prioritization and sequence of these additional preclinical products and their respective clinical applications.

And again going forward, we will not be providing you detailed guidance or updates on each of our preclinical programs.

Given the focus on our plan to develop our clinical stage product candidates were also withdrawing landowners previous guidance for communicating additional IND filings and this includes additional indications for the product candidates currently in clinical development as well as on.

Our preclinical portfolio.

Okay.

Turning now to partnerships, we remain very excited about our development and commercial partnership with <unk> bio for <unk> core and <unk> 13 in China and other Asian markets.

The land dose and Leann bio teams are already collaborating on the development of these product candidates and we look forward to our future success together.

Now before we open the call to your questions I want to emphasize that this is an important time for land dose.

Look forward to collaborating with the landowners team to advance our high impact clinical stage product candidates and the entire board and Chris and I are focused on positioning windows for success.

We believe and we're confident the future is bright for land dose and there are significant opportunities for partnering and commercialization ahead as we enter our next phase of growth.

We have a tremendous amount of confidence in our platform and look forward to updating you on our efforts.

So with that we're happy to take any questions. You may have Andrea if you would poll for questions. Thank you.

We will now begin the question and answer session to ask a question you May Press Star then one on your telephone keypad if.

If you are using a speakerphone please pick up your handset before pressing the keys.

To withdraw your question. Please press Star then two.

At this time, we will pause momentarily to assemble our roster.

And our first question will come from Chris Howerton of Jefferies. Please go ahead.

Great. Thank you so much for taking the questions and obviously a pretty exciting and.

Shall I say tumultuous time for lenders, but I think positive things ahead, so I guess.

Two questions for me one would be you know how are you thinking about the current kind of cash balance and capital deployment towards clinical programs versus you know a prioritization of other things and.

Business development, and I guess things like that that you can say at this point and then the second question was around ulcerative colitis with respect to the severity of the disease.

What is the right kind of patient population or what information did you see in the homelink or prior clinical results that encourage you to continue development there in ulcerative colitis, and maybe a different patient population. Thank you.

Yeah, Thanks, Chris I think.

Chris I will take your second question first and then I'll come back and answer your first question.

Yeah. So.

The phase II data, we saw in ulcerative colitis.

As we looked at that we were very encouraged and it was a different patient population that is typically studied in phase two studies that we included mild patients and when we did our subset analysis.

The milder patient dataset was harder to interpret those with active disease, we think oh.

<unk> had some benefit but the moderate population, which is where most of the competitive products have focused their study.

Studies are we we're right up there with kind of best in class drugs. So we felt that that was in and we're talking about placebo adjusted.

Remission rates, so we're very encouraged by that.

We didn't have as many biologic exposed patients that we were hoping for but those patients responded well also so we think that the.

The encouragement from the moderate patient population the encouragement from the small group of patients that were previously.

Previously exposed to biologics and still did well on O. Milan Court gives us the confidence that we have an active drug that can produce really good efficacy results and we really felt that we wanted to understand the.

The performance of the drug in these populations through additional clinical studies before locking into a larger phase III study as you know our powering assumptions.

Sample size calculations are driven on what data you have from previous studies and we feel that we will be in the best position to.

To accelerate that.

And this by gathering some additional data in some of these population moderate the biologic dispose we haven't fixed on any specific.

The study designs, yet, but that's what Ken and I, along with outside advisers youre going to be focusing in on and on the balance sheet I'll kick that over to Tim.

Yeah. Thank you, Chris and Chris maybe I'll start out by I know, we spoke briefly last week.

Just saying where we're in day seven.

In terms of this leadership transition.

But having said that what I think we can say is we've got over $100 million in cash I think we indicated that that carries us through the next two years.

And again, why we don't have a.

<unk> heard US say, we don't have a precise design for <unk>.

A phase II B study given our experience in phase two we have a pretty good idea of what these studies cost on a per patient basis. So you know we.

We feel like the cash that we have is going to carry us through that next couple of years, one and two that given this refocus and re prioritization on these kind of clinical stage assets, that's where you're going to see us deploying the money I think is that as that rolls out over the next couple of quarters, we can certainly.

Abide more detail, but I think that gives you a general idea of where we see the cash going in the future.

Yeah, No that's really a that's helpful I appreciate that and.

It maybe if I could sneak in one more was just the idea of you know in terms of the phase two b or ulcerative colitis patient population I think one of the questions that I always had from an external perspective was is dose was dose explored fully so I guess, if you had any comments about them evaluating additional.

<unk> dosing regimens or concentrations. Thank you.

Yeah, I mean look I think.

Anybody who's actually look at the dataset understands we did look at.

Half, a gram and Gram the active ingredient was slightly less than that 440, and 80 has been communicated by the company more recently as the dose groups.

That was driven based on the multiple Oh pig models that we did and where we were seeing a dose plateau and where we felt that we saw a maximum dose effect that the the pig a local activity translates pretty well.

Based on historical you know our models to the human population. So that's how we were driving the dose. However, we did not really see a.

A clear dose response, and so part of what we are wanting to determine by looking at additional patients is try to tease out right.

The lower dose is truly a dose plateau or if some patients may benefit from the higher dose of a grant.

It's not off the table to even look at higher doses are safety margins were quite significant in both animal studies in the healthy volunteer studies. So we are going to look very deeply at this.

We are going to be confirming and consulting with external advisors as well as other industry consultants, who have experience in these disease areas and also really looking more deeply in mining that dataset to tease out if theres other findings, but I think right now we're not ready to declare what the optimal dose is moving.

Forward and.

And I think that you know we're encouraged by the fact that we don't think we're near.

Dose limiting toxicities and we think we have a healthy margin above that so stay tuned we don't have details to share at this point, but figuring out the right dose is definitely part of our plans ahead.

Okay, all right well I really appreciate you guys, taking all the time to answer my questions and indulging. So thanks again.

Thank you Chris.

The next question comes from Jessica Fye of J P. Morgan. Please go ahead.

Hey, guys. Good morning, Thanks for taking my questions are completely agree on the updated strategy on homeland card to do some more phase two b work here. So on that note can you talk even in broad strokes about the trial design, you're envisioning or considering for phase two b should we interpret the comments you made.

A few minutes ago about the data and mild patients being difficult to interpret suggesting that we should not necessarily inspect expect a comparable patient population enrolled in phase two b as what you had previously outlined for phase three and I guess I'm curious as it were.

Relates to powering that study to the extent it may enroll a patient population that is different from the moderate to severe patients. We see studied and many other U C trials.

How you just even for powering that study kind of come to a view on what the placebo arm would be expected to deal. Thank you.

Yeah, just a great great questions. So first.

One of the adjustments that we had already made even when it was.

Joseph is leading the design of the phase III was removing mild patients without active disease.

I think one of the questions. We have is should we.

Still include mild patients with active disease or.

Or should we stick with the more moderate and maybe moving into the severe as is traditional with the study. This is always a trade off with you know how many patients.

Get biologics earlier before they can put their severe how many we want to include that were previously exposed.

And whether or not the <unk>.

Mild with active disease isn't appropriate population now we havent determined that I think we are pretty confident that we're not going to include mild patients without active disease, and we want to make sure that we have sufficient numbers of moderate Ah.

Ah patients because we think if we reproduced the dataset from phase two in the moderate Ah.

And powered on the moderate alone that we could have had more robust.

Findings meeting statistical significance.

So we will be looking at that very closely one thing that we haven't fixed in on is whether we do it.

Stirred up a single study in repeating a study in.

Moderate to severe patients with or without biologics is are we better suited to do two studies, one that might be more moderate biologic naive.

Maybe mild with active and moderate maybe moderates as you know there aren't that many severe disease and.

The more developed countries right and and systems are they haven't been exposed to biologics, but we could consider a separate study that just looks at those that were biologic exposure I'm just sharing kind of the early.

Thoughts and thinking around this this is why we have some an advisory meeting coming up we have other consultants, we're engaging and so this is the key question you're asking is what we want to do is determine what are the right assumption how many patients do we need to enroll what's the best way to provide the most robust signal so that.

Everybody understands that when we do the design of Phase III study that we understand much more clearly what assumption should go into that how we power that and how to ensure that we have a pivotal trial that meets it statistical significance end point, so hopefully that answers the question.

Yeah. That's that's great and then just shifting to the slightly earlier studies, whether it was the phase two for homeland current crohn's or the phase one be for the next 13 can you just remind us what the target enrollment had been for each of those studies and maybe help us think about where it could go.

Yeah.

Yeah, I don't remember exactly I don't know, Tim I want to say we.

Crohn study, we had 80 patients treated as my understanding or it may have been 40.

Versus 40.

This was not a.

<unk> powered for statistical significance, even the company acknowledged that and so part of the reason for a re guiding on the Crown study is.

We want to understand well what does the timeline and sample size look like if we did powered for statistical significance right look we we don't dismiss the idea of exploratory clinical trials being able to draw conclusions off of non statistical data.

We wanted to make sure that if it was possible to do a larger study to drive toward a statistically significant benefit in crohns that we would do that.

I can't tell you right now what that sizing looks like how easy that would be to achieve based on enrollment and timelines, but that is definitely something that's on the table as it goes for an expert team and also quite as this is a dose ranging study. This is.

Less critical to drive for clinical outcome right are powering it was not intended for that nor do we think that it's appropriate to try to drive that toward a clinical outcome study, but we do want to look at that study as well to make sure. We're gonna get reliable trustworthy information with the current sampling.

That exists in that AR, and we'll re look at that as well and that's why we've also removed the guidance of the topline data as we determine the appropriate enrollment and sample size for this study as Tim did you want to add anything to that.

Oh, just the only thing I was going to say is we will follow up with you afterwards and just because.

Because I think Chris nor I have the numbers off the top of our head but.

It's easy for us to do.

Grab afterwards and sent to you.

Great. Thank you.

Yeah.

The next question comes from Thomas Smith of SDB Leerink. Please go ahead.

Hey, guys. Good morning, Thanks for taking the questions just.

So we're in that's pretty important transition point here maybe.

Maybe for Chris and Tim can you just talk to your level of confidence in some of the underpinning science and translational data that we've seen to date.

Yeah, I have to say.

We have tremendous confidence in this research platform.

In the.

Data that drove.

The selection of the lead compounds.

I have to say I've been involved with this company from inception.

We're the original investors as part of the perceptive.

Funds.

Is ontogeny collaborated precept is not targeting venture funds then percept. This hedge funds are invested in this and the thing that was most compelling was the great work that was done in the lead compound or Milan Court.

When we first looked at this and.

And before it was spun out into landowners there were multiple rodent models that looked very good showed good concordance on.

Inflammatory biomarkers.

Downregulates the pro inflammatory cytokines up regulate the anti inflammatory cytokines.

And there were different induction models of inflammation.

We went further.

With pig data because we wanted to ensure that we really understood the dose activity relationship with a gut restricted drug we think a lot of drugs that they.

Rushed into the clinic on raising data alone didn't really understand what was happening in the gastrointestinal tract and we got.

Good concordance and good understanding of the right dose.

It was localizing in the gastrointestinal track, how well it was penetrating the epithelium lining where we were seeing a dose plateau, how persistent it was to give us confidence in the once daily dosing.

And so we think that the selection of our Milan Court and how robust the data set has been to date rate proves that platform and we're seeing that similarly with the second drug that's been brought into the clinic annex 13 with some of the signals and Biomarkers we saw.

Even in the healthy volunteer study.

Then a third pathway was identified which is in preclinical testing.

So we have tremendous confidence in the research engine the pipeline the promise of the future in some ways comments, we were almost more successful sooner than we anticipated and we felt that okay in order for us to get this right we need to focus on the products we have in the <unk>.

Clinic, let's make sure we get that right because that will prove research platform that will prove these pathways that will prove that the lance platform really understands how to drive the best drugs and by the way. This is not new to the industry Youre seeing a lot of a good AI machine learning applied.

The understanding how to find the optimized product candidates, but these are proving out in both preclinical and clinical testing. So in no way do we waiver at all from the strength of the research platform in the future of these products.

Understood. Okay. Yeah. That's helpful. Chris Thanks for the color there and then.

Just on the AUM, a lack or phase <unk> in ulcerative colitis, and the phase II Crohn's and I understand it's early days here.

Still a lot of moving parts I guess just at a high level.

And understanding a lot still to be refined but do you have a sense.

How are you thinking about the timing for potential next clinical data points here.

Yeah.

Yeah, Tim do you want to cover that one.

So I think Tom It is as you said, it's still early.

Well you know Chris has.

Been around the company for well since its founding.

I'm I'm at day, seven here and I think one of the things we did in the press release.

Other thing we did in the prepared comments.

I think to go out of our way to say look.

There have been you know theres been a lot of guidance out there from the company historically on.

You know really granular things and and I think as Chris said too we've had tremendous success as a company in the early stage discovery work. This incredibly strong foundation that we have with the Lance AI platform.

But the the most important thing.

And again paradoxically.

The most important thing we need to focus on this clinical strategy for these incredibly valuable assets in in this.

Immune mediated inflammatory inflammatory disease space. So so that's our focus would ask you and others for just a little bit of forbearance at least in the short term here, while we get our legs under us and make sure that when we're coming back to you we're coming back to you with you know really ration.

All thoughts on design on endpoints and on timing as well.

Chris anything that that you wanted to add the only thing I would add is that aside from the currently enrolling studies in patients we have not revised guidance on la B P. Fours phase one we've shown historically that we can execute on these phase one studies a single ascending dose multiple ascending dose studies. So we do expect.

That was guided on second quarter data, we are still retaining guidance on that study, but the other ones that we want to make sure we have the right sampling.

And we will be communicating any revised timelines and any adjustments to those two studies.

As soon as we lock that down and we can't say exactly when that timing would occur.

Got it okay, great. Thanks, guys I appreciate the updates on the color.

Great. Thanks, Tom Thanks, Thanks, Tom.

The next question comes from Steve feed House of Raymond James. Please go ahead.

Yes, Hi, this is to more of an incredible enforced D C codes.

Another question on Phase II B study, so I think the original positioning what's to be pre biologic and sort of mild to moderate Ah patients at the white space between generic treatments in biologics.

Are you, saying now the highest unmet need is the moderates and post biologic Southern and then maybe can you also talk about the target effect size.

That will allow you to move forward into phase III.

Yeah. So.

This question has been.

Interest Orlando's for a couple of years now and.

I think that.

We pursued the mild to moderate four O Milan court initially because it.

It was clear there were not many companies working in that space.

And even our advice from our clinical advisors right key opinion leaders right.

They were longing for a drug that works in that space pre biologics and secondary.

Secondarily, it's easier to enroll those patients that have not been exposed right. So it was a way to get earlier data.

However.

We also recognize that.

To really compete in this area you need to prove your utility.

And the more advancing patient and that's moderate and increasingly more patients who were exposed to biologics who are not well control.

And so I wouldn't say shift in strategy.

In any way, but we want to better understand and in fact, we included those exposed to biologics into phase two and we had planned.

To include a minimum number a much higher number.

Sage wise in the end what was described as the phase III study previously so we are definitely interested based on the signal in a small number of patients in the in the phase II <unk> study ought to pursue that I think the broader question that we have is we have two drugs that are both got re.

Strict it going after ulcerative colitis, and Crohn's and what is the optimal development strategy when you have to drive it.

Could be that we are positioned one more favorably depending on the course of disease and stage of disease. It could be that we they are complementary it could be that there's some combinatorial strategies that we could pursue but right now the goal is to clearly demonstrate.

These unique drugs activity in.

As broad a population, meaning we need to understand how it works and moderate we need to understand how it works with biologic exposure and whether we.

Pursue that mild active disease patient and I think that's something we're gonna be looking very closely at but yeah. I don't know that we've been that emphatic or I was not aware that there was any communications, saying that we would not pursue biologic exposed because that's always been a part of the broader strategy.

Okay. Thank you for that and then maybe for your Phase II B study and you see you have a relatively broad guidance for when we will be initiating the study in 2022 can you just talk about some of the factors. There you know what maybe pushed this into the second half.

Well I don't know if you're if you're speaking of data read out is really hard to guide.

Guide because we don't know what the sample size is and what you have to calculate enrollment I think if youre, saying when we will initiate the <unk>.

New studies, Yeah, I think look we're working closely we're meeting with our.

Advisors and consulting before the end of the year.

We are starting to dig in as Ken said stay seven and so.

We're excited to get deeper in our understanding.

You know all of the data sets are being able to apply what Tim and I have both done with seeking the right outside advice from the experts people who were involved in other clinical trials across the industry in this space.

Looking more deeply at the literature and what we've learned from other drugs have failed and those who succeeded in these patient population. So.

I think we hope to have a good idea of that as we.

Our move into the first part of next year, but we're not ready to say you'll know when we are ready to communicate that via a press release in any corporate updates and we don't want to.

Can you write the <unk>.

Abbott of trying to forward project activities.

Activities.

Before we have that locked down, but Tim do you want to add to that.

No I think you've I think you've covered it well Chris Thank you.

Okay.

Okay. Thank you and then a final question just been Crunch. This is just to clarify you know you have a company sponsored phase II study and then there's also the Icahn school of Medicine Phase II study.

Just to clarify are those studies, both enrolling right now and then to what extent is the icon study a gatekeeping facts are too you know initiating a phase III program.

Yes. This is Kim thanks for that question. So both studies are indeed enrolling and have.

Enrolled patients already.

I don't think we view the the the phase two single site study with with Mount Sinai as.

As gating to a pivotal phase III program it will certainly inform.

You know our our insights into into how on the land core works in Crohn's disease, and Crohns disease patients.

Obviously, how it compares to.

Two a biologic as well, but there's a lot of them.

Really interesting mechanism mechanistic work and testing that is going to be done there.

That is going to yield I think great benefit.

Two of them obviously.

To be determined as we are as we move along but yes.

I don't see that as gating.

Okay. Thank you very much with you but.

Thank you.

The next question comes from per car or graph all of Jones trading. Please go ahead.

Hi, Thanks for taking my question, Firstly really wait for the permanent leadership to come in before finalizing trial design protocol.

These changes are some steps such as optimizing the borrowing could be started sooner.

And at some point ups. Thanks, Yeah.

This is where I'll just add.

It's nice that both Tim and I have a lot of experience.

Leading companies, making these decisions as a former public company Ceos.

We will collectively along with our fellow board members deter.

Determine if we are ready to move forward and really that has more to do with we want to find the right CEO and we don't know how long that's going to take and we're not going to arbitrarily hold back.

The program right moving forward.

We will apply our best judgment and experience in working with our advisors.

Companies I mean in place within the company are external key opinion leaders.

Doing other competitive landscaping research.

We obviously have regulatory bio stats.

People, we work with our in and out of the company and so that's how we plan to do it and we're not arbitrarily, saying, we cannot lock anything down until obviously, our best you know our hope is that we can find that CEO soon and they can be part of that process and in development, but Tim you should add to that.

Yeah.

I would just echo what Chris said I think we feel comfortable you know first of all with having made the strategic decisions that we announced today.

Again, just given our experience and and obviously other members of the board as well but.

Secondly, I think.

You know drug development is.

You know is waiting here patients are waiting and I think with with Chris's background with the company and with the set of advisors that we have around the company, we feel very confident in our ability to design and implement the appropriate phase two b program here.

Sure.

Got it thank you and secondly on Koonce. The company had previously guided on testing both on the non core and an extra day.

But I didn't see any commentary on the coding and coons and in our press release. So just wondering if do you think it makes sense to do a plan to explore both both deep athletes in Cogs.

Thanks for taking my questions. Yeah, I think right now we're following the same path right now is I'm a lot core I'm as a yes in terms of looking at you see first.

Again, I think we will.

I decided that and determine that we.

We still have highlighted crohn's, but look there's a lot of programs that we've highlighted right. So we've got you know seven.

Seven different clinical programs that were saying is the top priority. We know that the company had previously communicated many other ind's that were planned right with other new indications new product. So I think that right now we have a healthy balance sheet, we can generate a lot of compelling data and that we will determine what the right.

Timing.

And interest in that Crohn's development program is as we start to uncover.

More data for both on the oncor and expertise in ulcerative colitis.

Okay.

Thank you thanks to everyone else as well I appreciate all of you joining the call today and again hopefully you've heard from US today, we're refocusing were re prioritizing things a lot of confidence in <unk>.

In particular, the clinical stage assets and our goal here is to communicate to all of you.

The confidence that we have and being able to put in place the right clinical strategy for these very promising asset. So thank you again look forward to updating you in the future Andrea.

The conference has now concluded. Thank you for attending today's presentation and you may now disconnect.

Hum.

[music].

Yeah.