Q3 2022 aTyr Pharma Inc Earnings Call

The conference will begin shortly to raise your hand during Q&A you can dial star one one.

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The conference will begin shortly to raise your hand during Q&A you can dial star one one.

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Okay.

Good afternoon, ladies and gentlemen, and welcome to the a tier pharma third quarter 2022 conference call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will be given at that time.

A reminder, this conference is being recorded for replay purposes. It is now my pleasure to hand, the conference call over to Ashley Dunstan.

As director of Investor Relations and corporate communications.

Mr. Duncan Smith, you may begin.

Thank you and good afternoon, everyone. Thank you for joining us today to discuss <unk> third quarter 2022 operating results and corporate update we are joined today by Dr. Sanjay Shukla, our president and CEO Ms. Jill Broadfoot, our CFO and Dr. Leslie Nagel our V. P of research on the call Sanjay will provide an update on our corporate.

[noise] strategy, including our clinical program for Epic Ahmad and research and Discovery program Jill will review the financial results and our current financial position before handing it back to Sanjay to open up the call for any questions before we begin I would like to remind everyone that except for statements of historical facts.

Statements made by management and responses to questions. On this conference call are forward looking statements under the Safe Harbor provision of the private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ materially from those in such forward looking statements. Please see the forward looking statement disclaimer in the Companys press.

Please issued this afternoon as well as the risk factors in the company's SEC filings, including our most recent annual report on Form 10-K subsequently filed quarterly reports on Form 10-Q and in our other SEC filings undue reliance should not be placed on forward looking statements, which speak only as of the date. They are made as facts and circumstances underlying these forward.

Looking statements may change, except as required by law <unk> pharma disclaims any obligation to update these forward looking statements to reflect future information events or circumstances, I will now turn the call over to Sanjay.

Thank you Ashley.

Good afternoon, everyone and thank you for joining us for our third quarter 2022 results conference call.

The third quarter saw the initiation.

A global pivotal phase III study.

Our lead therapeutic candidate absolute <unk> in patients with pulmonary sarcoidosis.

Most prevalent form of interstitial lung disease or ILD.

We dosed the first patient in this study in September .

Meeting the aggressive timelines and guidance.

Amidst the current market conditions.

We tend to focus our resources on prioritizing absence yet.

Which is our highest value program to ensure a timely and successful completion of this study.

As we begin I will summarize a few additional highlights since we last spoke in August .

We announced the publication of results from the Phase one B study.

Study.

Modern patients with pulmonary sarcoidosis in the peer reviewed medical journal.

We presented a poster at the European respiratory Society or IRS International Congress on findings for an antibody for immunohistochemistry detection of <unk> in patient tissue samples.

And our <unk> is absolutely binding partner and these findings suggest that this antibody may provide an extremely useful clinical tool potentially eating in patient selection stratification.

We received FDA fast track designation for a softer demand for the treatment of systemic sclerosis.

SSC or scleroderma associated ILD.

We announced a research collaboration with dual systems biotech AG.

The company specializing in custom.

Genomics to identify and validate tenant target 10, new target receptors.

Four trna synthetase from our intellectual property or IP by 2025.

This collaboration is a way to potentially accelerate drug discovery efforts and identify new drugs from our platform.

And finally.

We received a notice of allowance from the U S patent and trademark office for anti <unk> monoclonal antibodies, which is the first to be granted to our IP estate for this program.

We've experienced another quarter of crisp operational execution, both internally and in cooperation with our partners and collaborators.

And we anticipate a strong finish to the year.

Now, let's focus on some more specific updates around our clinical program for absolute cinemark.

As a reminder, the Fairmont is a first in class immuno modulator for fibrotic lung disease.

So <unk> is a novel FC fusion protein based on the naturally occurring splice variant.

Although long enriched trna synthetase Hearts fragment.

Downregulates aberrant immune responses and inflammatory disease state.

So <unk> has been shown pre clinically to down regulate inflammatory cytokine and chemokine signaling.

And reduce inflammation and fibrosis.

And RP two receptor is up regulated on key immune cells during active inflammation.

And as enriched in inflamed lung tissue.

Im still fit Ahmad bind selectively to MRP too and therefore has the potential to normalize the immune system, serving to resolve inflammation and prevent progressive fibrosis.

Thereby stabilizing lung function and alleviating morbidity and mortality.

We're developing <unk> as a potential treatment for patients with ILD, a group of rare immune mediated fibrotic lung disorders.

Our initial ILD indication is pulmonary sarcoidosis.

Sarcoidosis is the most prevalent ILD and it's characterized by the formation of Granulomas, which can occur in any Oregon.

But predominantly affects the lungs.

If left untreated can lead to irreversible scarring of fibrosis, which greatly increases the risk of death.

We estimate that there are close to 200000 patients with pulmonary sarcoidosis in the U S and around 150000 in the major European markets with.

With another 20000 in Japan.

Up to 75% of patients required treatment for their disease.

And approximately half of these will have progressive disease despite treatment.

Around one in five of all patients will go on to develop lung fibrosis.

First line treatment is typically corticosteroids, which may effectively control symptoms, but are associated with severe debilitating side effects.

Particularly with chronic treatment.

Patients unresponsive to steroid treatment cytotoxic immunosuppressants or biologic immuno modulators, maybe but are also known to cause serious side effects.

Use of all of these therapies is imperative and not supported by current clinical evidence standards.

We believe the addressable market for Sofia, <unk> and the <unk>.

Three geographic geographies mentioned is around 200000 patients.

Even with conservative assumptions this represents a significant market opportunity and sarcoidosis alone.

<unk> has received orphan drug designation and fast track designation from the FDA for sarcoidosis.

We see upside potential for our Sofia demand and other forms of ILD.

This includes indications such as scleroderma related Iot.

We have also garnered FDA orphan drug and fast track designation.

Also other connective tissue disease disease related ILD.

And chronic hypersensitivity pneumonitis among others.

These diseases share overlapping immune pathology with sarcoidosis.

And others, having limited treatment options and absolute <unk> has demonstrated efficacy in animal models.

These diseases.

Taken collectively this represents a multibillion dollar market opportunity for absolute fit a modern ILD.

<unk> is poised as a front runner front runner.

<unk> opportunity.

Now, let's recap the data we have generated perhaps some <unk> and some updates on the current peso fit study.

In September .

Number 2021, we reported clinical proof of concept for us. So good amount based on positive results from our phase <unk> study in pulmonary sarcoidosis.

The study, which included a forced steroid taper demonstrated safety tolerability and consistent dose response for absolutely been Ahmad on key efficacy endpoints and improvements compared to placebo.

Including measures of steroid reduction lung function sarcoidosis symptom measures and inflammatory biomarkers.

Just this past week the full results from this study were published online in the peer reviewed medical journal chest.

Dr. Daniel Culver Chief of pulmonary medicine at the Cleveland Clinic services.

<unk> as lead author.

This marks the first peer reviewed publication of clinical data, perhaps to put them on.

For that matter any trna synthetase derived therapy in a major medical journal.

These data indicate that <unk> is providing substantial benefit to patients.

Proving lung function and symptoms of cough.

<unk> breadth and fatigue.

All while reducing their toxic steroid burden.

According to medical experts. This is the first randomized placebo controlled trial of any therapy for pulmonary sarcoidosis.

That demonstrates effects on physiologic and quality of life measures concurrent with steroid reduction.

With a full data set now available for review.

We expect this publication will generate additional education awareness and support for <unk> demand.

Among the specialists and generalists provider community.

Particularly as we are currently enrolling for ISO fit.

<unk> is a global pivotal phase III randomized double blind placebo controlled study to evaluate the efficacy and safety of <unk> in patients with pulmonary sarcoidosis.

It is a 52 week study consisting of three parallel cohort randomized equally to either three milligrams per kilogram or five milligrams per kilogram of <unk> or placebo.

Dosed intravenously once a month for a total of 12 doses.

The study intends to enroll 264 patients with pulmonary sarcoidosis at multiple centers in the U S Europe and Japan.

The trial design incorporates a forced steroid taper and the primary endpoint of the study is steroid reduction.

Secondary endpoints include measures of lung function and sarcoidosis symptom.

We've dosed the first patient in the study.

Several sites in the U S open for enrollment.

We expect additional sites to open in the U S.

Later this year.

I will remind you that this is a global study.

We held a productive meeting with European investigators during GRS in September .

We now have rapidly achieve regulatory approval to proceed with the study in a number of countries, including the UK, Netherlands, France and Spain.

We anticipate sites opening for enrollment in those countries.

Coming months in early 2023.

Finally, our partner <unk> pharmaceutical has also completed submission of the clinical trial notification or Cts in Japan, and we could see et cetera. They are open for enrollment by the end of the year.

We're highly encouraged by the rapid pace of this progress.

As it permits us to initiate the study in those regions and signifies our alignment with these regulators on the trial design.

Including the steroids bearing primary endpoint.

I want to give kudos to our regulatory group led by Dr. Bob Ashworth for skillfully navigating towards these regulatory approvals.

<unk> is expected to be the largest interventional study for patients with target doses to date.

There is also the largest study that <unk> undertaken in the history of the company.

We're laser focused on ensuring that this study receives the resources it requires and we intend to focus on.

Our resources on Epsilon to ensure its completion.

So shifting to our preclinical and discovery programs, let's discuss some of the progress with our pipeline.

This concludes <unk> 2810, or 28 and today wed.

We'd like to provide a strategic update regarding this program, which we have in advance to be phase one already.

Due to current market conditions, and the need for prioritization of capital most importantly, focusing our resources on the <unk> study.

We've made the strategic decision not to use our internal resources to initiate a phase one study of 28% this year.

We intend to look at other potential non dilutive avenues, including academic collaborations.

Our other funding sources to bring this program forward.

Multiple academic centers are particularly interested in advancing 2018 and rare aggressive cancers, where many patients.

Unresponsive to currently available treatments.

Such as neuroendocrine prostate and pancreatic neuroendocrine tumors.

Recent published literature regarding the role of <unk> in these types of cancers and interest from these centers have encouraged us to consider interrogating.

The anti <unk> agents, such as 2018 in these indications.

This includes an exciting publication recently from one of our key collaborators Dr. <unk> and his colleagues from the University of Nebraska Medical Center, indicating.

The role of <unk> in promoting metastasis, and conferring therapeutic resistance in neuroendocrine like prostate cancer.

Which outlines the potential for the therapy.

In this aggressive tumor type.

As a reminder, 20 attendance fees, one ready, having completed IND, enabling activities, including GMP manufacturing in GOP Tox studies.

And we have been granted allowance from the U S patent and trademark office for the patent for anti <unk> antibodies, which covers us for 2008.

I'll close with reiterating how excited we are.

Our trna synthetase platform and what it's yielded thus far as we get closer to our mission of translating our trna synthetase biology.

And your new therapeutics for fibrosis inflammation and cancer.

We've advanced <unk>, which is derived from a fragment of histidyl trna synthetase or hard.

<unk> phase III study.

Meanwhile, we've identified and validated the.

The receptor target for fragment of another trna synthetase, alanyl trna synthetase or ours.

We expect to reveal the receptor of yet a third fragment. This one from Astra deal trna synthetase or darts.

In the near future.

I'll now turn it over to our Chief Financial Officer, Jill Broadfoot to review our financial results.

Thank you Sanjay we ended the third quarter 2022, with $79 6 million in cash restricted cash cash equivalents and investments.

Research and development expenses were $9 9 million for the third.

Third quarter, 2022, which consisted of product development and manufacturing costs.

Furthermore, in 2008 to 10 programs as well as startup costs for the phase III study.

Yes.

General and administrative expenses were $3 6 million for the third quarter 2022.

Common shares outstanding were approximately 29 million and fully diluted shares were $34 million as of September 32022.

From a balance sheet perspective, we are comfortable with our current cash position, which we believe enables us to carry out the most meaningful value driving catalyst for the company.

While running a large global phase III study in a rare disease, such as App stuff. It is capital intensive we do share a portion of the cost with our partner Kieran who is responsible for the cost of all operations and patient costs in Japan and purchases drug supply from us with a small markup.

And as a reminder, under our agreement with Karen we are eligible to receive up to an additional $165 million in milestone payments of which the majority of our development and regulatory related.

As we stated on the call today, we have made some important decisions around our pipeline that will allow us to better manage our cash at this point in time, we have a financial and strategic plan for the company.

Fund operations to the data readout for <unk>.

This plan contemplates our current cash balance the potential for milestones from Kieran and potential proceeds from the use of our existing equity vehicles.

Now I'd like to turn the call back over to Sanjay before we open it up to Q&A.

Thank you Jill.

We are highly dedicated team.

With a track record of exceptional execution, and we continue to make outstanding progress with efficient use of capital.

We understand that the markets have been challenging as of late.

And certainly know that they do not.

And any way adequately reflect the intrinsic value of the company.

Including the data and progress we've generated for <unk> demand.

Considering its stage of development as of late phase asset.

And its potential to address a multibillion dollar market.

The prioritization, we've discussed today provides us with the ability to ensure adequate resources to successfully advance the highest value driving catalysts for the company.

I'll close with a comment.

Recently from one of our top shareholders.

Who told me HR as a platform company, that's generating transformative Reese.

Our research and clinical opportunities.

From our trna synthetase biology of space.

This is a company that I think.

Is poised right now to be a leader in.

An area of interstitial lung disease, where as I mentioned, we are the front runner.

So we appreciate your interest continued support at.

At this time Jill.

And I will be happy to take your questions. Thank you.

Ladies and gentlemen, as a reminder, if you would like to ask a question. Please press star one on your Touchtone telephone.

Again for any questions. Please press star one one.

Sure.

And our first question will come from Gregory <unk> of RBC. Your line is open.

Hi, This is <unk> on for Greg Congrats on the progress and thanks for taking our question maybe.

Maybe first on the phase III trial.

Some companies in the space of Athene, some clinical trial conduct slowdown could you just provide some color on what you're seeing around site activation and government cadence is was your confidence level and the guy that timeline of the phase III trial. Thank you.

Sure I appreciate the question. So it's quite early to necessarily get into projections and the trajectory, but what I can tell you is the.

The excitement from the pies worldwide.

<unk> been waiting 20 years, sometimes.

Sometimes longer for a therapy like this to get to this stage. So certainly from that perspective, I think you can look at the pace of our regulatory approvals.

And even the fact that we were able to get a patient enrolled basically about three months from getting the green light from the FDA. This speaks to the rapid sort of interest and uptake.

To enter our trial I also think the data we produced is checking the box in all the areas that these experts have been waiting for probably going back.

50 years, a drug that can reduce symptoms improve symptoms improve lung function in all doing that while reducing steroid. This has never been seen before.

So what do I anticipate I anticipate a fast start I'm glad we've started fast with the first patient.

I also have seen quick pace of regulatory approvals.

I will be at three sites next week.

So I think I think it's something it's off to a fast start here, we're going to have to watch to see is this is the largest.

Sorry to doses trial ever how.

How we really progress here and I think I'll have a better estimate of that once we get a good 30, 40 centers up and let's allow them to enroll let's allow them to a role for a few months I think our publication is also really really important this.

This is the first major sarcoidosis publication from our clinical trial, I'd say going back to the Infliximab data in the 2000.

So this is a field that is hungry to actually interrogate absolute <unk>. They like the initial data and I can tell you that patient certainly are responding well.

In that we are really trying to address their steroid burden.

<unk>.

I will get back to you to see how we're doing here, but early signs are very very encouraging.

That's great. Thanks for the color and then maybe secondly could you talk a little about your latest development strategy in scleroderma ILD and what do you see as the key differentiation of the mechanism of action that could drive clinical potential in this indication.

You.

Great, Yes, so scleroderma I think it's something that.

And honesty as an adjacent condition we are seeing.

Number of Pulmonologists and Rheumatologists after seeing our <unk> data and sarcoidosis become very interested Conversely, we've also received maybe rather surprisingly some some nice designations early from the FTA scleroderma ILD represents probably the worst form of <unk>.

<unk>, it's where some of the morbidity and mortality is just.

Really.

Really quite dramatic and these patients don't have treatment options. So while we have.

It's a good kind of feel from patients and providers and regulators.

You have to be careful about thinking about how do we.

Keep our eyes focused on sarcoidosis first.

So at this point.

I think we are really keeping guys on sarcoidosis, but it is really encouraging that based on really our data and even going back to our preclinical data we have animal efficacy showing up Sofia demand can impact sclerodermatous plaques.

Lung inflammation.

In mice.

So that translation is there.

So the story is there but right now we are staying focused on sarcoidosis last thing I'll say is we are looking more closely at <unk> expression in scleroderma patients. There's anecdotal evidence that <unk> is quite up regulated and some of those sclerodermatous plaques, but I think we have some time to to look.

More closely at that.

But certainly that is a opportunity that.

If we had if we had abundant resources and infinite resources.

Certainly is another large market opportunity sitting there for us.

That's great. Thank you very much.

One moment.

And our next question will come from Joe pin genus of HC Wainwright. Your line is open.

Hey, everybody. Good afternoon. Thanks for taking the question. So first just a little more on <unk>.

Obviously, it's early.

Just wanted to see I am not implying these are any rate limiting steps will wanted to get your sort of early views on how.

You view, the ease of screening patients and any particular geographies even in just the U S that you might see outperform even before the European sites come on board.

Yes, Hi, Joe Greg Great question.

Made some tweaks to our protocol based on our last study that I think are going to address.

Some of your points here.

Number one moving into Europe and Japan.

There tends to be slightly less.

Slightly less steroid administered in those patients that could have to do with.

The physiology of those patients.

But also.

There is a larger cohort of African African Americans black patients here in the U S.

Typically those patients have.

More severe disease that may require more steroids with that in mind, we've lowered the threshold and this current protocol to allow entry.

At seven five milligrams as opposed to 10, we think this is going to help us enroll and better fits the sort of treatment paradigms of Japan, and Europe , where they tend to use a little bit less so I'll start there and say that's going to help us I'll also say that compared to the last study where pet scans were used as an inclusion criteria.

And have now fallen out of favor five years later, we're now using <unk>, which is going to be a little bit easier to administer and readout more commonly viewed as a a better instrument to detect fibrotic patients or not we want to exclude those patients that are highly fibrotic and bring those patients in that are inflamed.

<unk> is I would say more validated instrument than pet scans. This is going to help us.

So I think those are too early.

Sort of tweaks that we've made in this protocol to allow for an easier entry into our trial and then the last thing I'll say is our data from the last study. The fact that we showed steroid reduction and we are the first therapy to really ever show the ability to improve symptoms and lung function, while reducing steroids. This is really important to.

So now that there's that experience from that last trial.

Patients are very very interested in our therapy.

Cause where not just showing nominal improvement in one or two end points, it's really all the endpoints and the one they care. Most about is can I get off steroids or can this help me reduce my steroid burden, that's going to be a real attractive asset for us as we think about enrolling worldwide.

That's helpful. Thanks, and then when you just look at the especially in this current environment. It's glad to see you guys being thoughtful about your resources. So.

How would you describe.

How much you're putting your background overall and RP to work.

Not on the backward or backburner, but just sort of.

Pausing, a little bit from a cash spend standpoint.

Yes, I mean, I think 28 10 is something that frankly.

When I think about it as opportunity.

We've landed on these indications.

This is the best fit for 2008, the moving forward these really rare.

Third line cancers, and especially these neuroendocrine phenotypes.

Really the indication where it makes most sense for 2810 to advance now when you think about these rare cancers.

They can be slow to enroll certain academic centers are specialists in there.

These sort of rare or types of cancer. So it makes sense for us to partner with those academic experts and because these are rare cancers, we actually have more access to non dilutive ways of funding.

Because because there is money out there for these sort of rare cancer. So it's an intersection of our data and number one pointing us in that direction, but these are.

Cancers that we should actually target with 28 10, and Conversely, it allows us to also work with academics.

At the end of the day serves us well under these current conditions.

So it's an intersection of really I think our data the opportunity with these experts in these rare cancers and then the fact that.

Given current conditions, we're grateful that we're probably going to have avenues at these centers.

So I think it makes sense for us.

Based on a lot of different factors to progress the program.

Side by side with these centers.

And Conversely, if of course, it does help us focus on <unk> as well.

Great. Thanks for the color Sanjay.

One moment.

And our next question will come from <unk> Zhang of Oppenheimer. Your line is open.

Great. Thanks, Sanjay and team for all the updates.

Could you just kind of a different kind of question I think it might be or at least with this but just a first question is.

We kind of we did a survey of high prescribing physicians pulmonary sarcoidosis everywhere.

I mean, we shouldn't have been we were shocked at just how much they use steroids and how much they want not want to use steroids 90, plus percent, 100% use steroids. The 90 plus percent want their patients to get off steroids to reduce steroids.

This burden right and you've talked about all the patient numbers.

Go into a potential enhancements at him on what about on the value side.

I mean.

Has any.

Have you done preliminary work as to what could be.

Comps for <unk> towards the data.

With two week petroleum itself in phase III and it was to get approved what sort of comp. So are we thinking about.

Assuming the drug gets approved I just got a follow up question. Thank you.

Yes.

We have spent some time this last quarter.

Looking at a little bit more closely at that we've done our own internal analysis excellent with an external firm that has interviewed experts and done some early payer work that you might be hinting too.

Our estimates were a little light and I think we're all learning that first of all more patients are on steroids and we expect it's a bigger issue and patients want to get off steroids. Conversely.

Pricing standpoint.

Most experts have come back to us and say the pricing of this drug.

If we start to see these kinds of steroid reduction effects, while also improving lung function improving quality of life.

It could be upwards to kind of what humira is getting.

That's probably on the high end, but you look at those drugs like <unk>.

These are drugs that generate billions of dollars of revenue for Roche in BPI.

Our drug would I think fall into a similar pricing bucket look those drugs just reduce the reduce the lung function decline.

Our drug is is preserving and improving lung function, it's improving symptoms.

Which of those drugs are not doing and doing so while removing steroids. So I think we're very confident now that from a pricing standpoint.

Would approach some of those similar IPF drugs, which is why a lot of the modeling estimates not only internally, but also with some of you guys have been actually changing.

So I do feel better again after our data that it is generating.

Bit more confidence.

The pricing of it.

<unk>.

<unk> pricing of the drug could be much higher than we initially expected.

Yes, no no thats, great Sanjay and then the other question just have is.

No.

I'm, sorry, you're asking there's a lot of data presented by larger companies, but I was a little surprised.

On the battery, but just how much volume it was around your presentations, even though I think you had far greater presentation at Ats.

What are you thinking in terms of strategic sort of view.

There seem to be a buzz.

As each year being kind of a small cap company with a product that could play.

Play really well to a multinational company wants to take this product harbinger.

Many countries many geographies of the world what are you thinking if I can churn in that regard thanks for all the questions.

Yes, I think it's a factor of a couple of things first the data needs to just get absorbed I mean, we put it out at Ats.

It takes a minute to kind of get worldwide. I think the publication is really going to help us and we've already seen even in a couple of days it's been up.

We have.

New interest.

From other parts of the world.

Pulmonologists are busy they are managing a lot of conditions.

Outside of the specialists. This is why I said, the generalist will start to pick up on this the other thing Thats happening is we're seeing a contraction in the <unk> space with a number of companies.

Kind of moving out of the space. They are finding their therapies are not working as well in preclinical and early phase testing, you'll see larger companies.

Moving out of the space. So this is why we feel like a tire is getting that buzz that you picked up on at Barcelona that our therapy is doing things previously not seen in sarcoidosis with other therapies.

And we are the furthest along and combine that with some competition kind of.

Going away here, we think that can help us certainly enroll.

And again, we could be we could come out of this sort of at the top of the wave here.

<unk>.

In a few years as what I think is a leading <unk> company last thing I'll say about IRS.

You picked up on this interstitial lung disease is where asthma and COPD was about 15 years ago at the IRS conferences around 2000 2005.

<unk>, new steroid sparing therapies, where needed and they came out Lama LABA.

Some of the anti muscarinic things like that for for asthma and COPD.

Now the shift for respiratory experts is how do we get better drugs and Iot you've seen United do some things with.

Pulmonary hypertension ILD.

But right now we are.

Kind of the leader right now for socket, we certainly offer sarcoidosis, but our therapy is something that could be really useful in a number of those other conditions. This is why we think it's a multibillion dollar opportunity and were hopeful to get noticed more and more in the coming years as we.

Get this data out.

Great. Thank you so thanks for the questions on the update.

One moment.

Our next question will come from Edward <unk> of Piper Sandler Your line is open.

Great. Thank you very much I appreciate the update.

And I really applaud the execution, especially on the phase III I understand the focus.

One of the things I've always appreciated Sanjay about tires youre close relationships with the academic labs, I think it's a really smart way to be.

Since 2010, my question has to do with sort of the broader utility.

The platform.

And are there opportunities to do partnerships.

With biotech soar.

Big farmers around some of these other areas.

Or is the goal really to do a lot of the early work yourselves and then do more tons of product type deals in the future. So I appreciate you taking the question.

Yes, I do think thank you Ted for the question I do think that <unk> data is clearly validated our platform and we're seeing that.

Through interest with.

Really across the spectrum.

Academics other companies really digging in.

Our dual systems collaboration is really about taking the lid off of our synthetase or state. We think we can do it faster better and frankly cheaper now with this collaboration.

As we crank out new targets and thus far this summer we had a new target with fibroblast growth factor coming out of <unk>.

One of our synthetase targets.

I think we're going to have Optionality now we're going to have the ability to say hey, do we want to take some of these forward.

We're not going to be able to take all 10 forward ourselves, let's just be honest not all 10 are going to be necessarily winners, but that's the other thing we like to be honest here at box at a tire.

But I think what's going to happen here is we're going to have an opportunity to look at these.

Frankly.

Engaging potential partnerships. That's another thing I'm load to talk too much about but I do think that now we're at a position where we generated more interest than ever in a tire HR was very much a show me something story.

We've done that now we have a process now we even had a partnership with a group out of Zurich that can I think yield a number of pipeline opportunities and I would say some of these will keep kind of under our umbrella others.

We're going to have opportunities to partner.

And I think that's something to expect here.

And then prepare for in the years to come.

Great. Thanks, guys.

One moment.

Okay.

And our next question will come from Yale Jen of Laidlaw <unk> Company. Your line is open.

Good afternoon, and thanks for taking the questions.

Due to your resources sort of focusing.

Do you still will conduct clinical preclinical study.

<unk> targets or or what did that approach.

<unk> was also showing.

Their budget as well.

Thanks, Joe.

This is really related to 2008 to 10 in the clinical program is as you can imagine moving into clinical studies.

That's where it really starts to get expensive we have a we have a mechanism and now a process that certainly from a discovery and preclinical standpoint.

There is no slowing down in fact, youll see acceleration in outputs.

But again.

We are very very capital efficient with some of those.

Those efforts, it's really moving into the clinic, where right now.

Absolutely fit being the largest in our late phase program.

We just thought it was smarter for us to really really reiterate and focus resources, there, but from a pipeline and discovery standpoint. No. These are these are all opportunities that we're going to still pursue I think for 2008, and we simply are taking a different strategy with that which I think will do two things number one it will put it in a home.

And perhaps with some.

Academic groups that frankly will be able to move it forward it had virtually.

Little to no cost to us so we can assume advanced therapy that way.

But but I think the game plan right now is to generate certainly more pipeline opportunities and then we can decide we can see I've always said, let's look at the data and now let's figure out how we want to move. This forward. It's an approach we've always taken we want to be data driven and I think from our pipeline.

<unk>.

No there is no contraction there.

Okay, Great. That's very helpful. As we talk about 2810.

Do you have some estimate in terms of.

The dollar could be saved.

Now the <unk>.

Clinical work over the next few years.

Sort of a rough estimate on that.

So I think.

Again.

How many dollars could be saved.

Yeah.

I don't think we have I'll, let Jill also answer here.

I wouldn't necessarily look at heart estimates here because one of the things as these are rare tumor types, which I think one thing we just have to call out here. It can take much longer to enroll in these rare phenotypes.

This is another part of our strategy that who is best.

Prepared who has these sorts of patients and access to them.

So I think from a time perspective, that's where we actually saved quite a bit from just a rough dollar perspective, Jill do you want to add.

Dollar perspective.

Not as significant and obviously it depends upon the trial design, which.

Looked at a couple of different trial design, depending upon how we wanted to approach that.

But you can say on average from clinical cost maybe.

Around $10 million or so.

And that's really what Sanjay was talking about.

How long that takes.

So that $10 million doesn't really.

Crude all of that overhead and distraction to the company as well that could occur over that.

Two here.

That's right that's right yeah early phase clinical oncology trials can sometimes take theres, a number of hurdles to move through.

It's also a rare phenotype, but roughly speaking.

$10 million for a program like that.

<unk> is a comp that most companies would.

Would look at there.

Distraction part is.

I wouldn't necessarily to hit it.

To do a lot of things here at <unk>, but I think this is this is the best thing for us and frankly, putting it in the hands of folks who maybe have these patients with neuroendocrine phenotype. They are quite excited to move.

The asset forward there and it also comes with the benefit that.

We may be able to tap into funding because we are focusing on these more rare and ultra aggressive tumor types.

Okay, Great and maybe the last question here is that in terms of the.

Clinical study in Japan.

Do you have.

How are you guys going to reveal in terms of property the size.

And then maybe any other colors.

That part of the trial.

Thanks.

Yes, I would say.

Roughly speaking.

No.

Regional like Japan regulators typically like to see at least from a global trial at least about 10% of the patients come from that region.

An indication of rare disease like this.

Partners are piggybacking off of our global data.

So, it's obviously difficult to enroll and power a trial in a specific region like Japan.

But I would anticipate right now early on.

Somewhere around 10% of our patients.

We will need to come from Japan somewhere in somewhere in that number around that range.

Okay, great. Thanks appreciate that and.

Okay. Congrats phone some so good they're thinking maybe sofa.

Thank you.

One moment.

Our next question will be from Sean Kim of Jones trading your line is open.

Yes, hi, Thank you for taking my questions and I apologize if I'm repeating questions that have been asked previously.

For the phase III.

Trial can you remind me what the.

<unk> plans, including the statistical powering also how much of a separation from placebo and there hasnt been baked in to that kind of calculation.

Sure sure happy to do that so our trial is powered with 264 patients.

Three dose arms Theres, a five milligram or three milligram and a placebo arm in each each arm is 88 patients.

We powered this trial.

Over 90%, 92% to be exact for for either.

The three milligram or the five milligram dose of showing statistical.

Statistical superiority to.

To placebo. So we have essentially two shots on goal with either of these two.

Much higher clip typically you want to power these studies at least 80%.

We've actually done them both.

Both of these.

Doses at over 90%.

In layman's terms, what are we trying to show in steroid reduction in absolute reduction of somewhere between two five to three milligrams.

Difference.

As in our NRI is meaningful.

In the eyes of experts for example, if you have a 10 patient coming in at 10 milligrams and getting an app so gets them down to seven and a half that's meaningful benefit.

It may not seem like a lot for us, but everyday removing two to three milligrams of prednisone.

It's up <unk>.

Moving that.

Decreases the overall cumulative burden and over the course of six 912 months. This is going to help you with cardiovascular metabolic.

Newark neuro effects of what's steroids to do so.

I hope that provides a little bit of color there.

Very well powered.

I'm a little bit.

Very particular about statistics, having having a background in that so I think thats something that we wanted to overpower if you will and we have two shots on goal to essentially show about two and a half and three milligram difference.

Okay. That's very helpful. Thank you and I guess, just one follow up question on that is.

You have three arms.

<unk> three <unk> against placebo.

What's the rationale behind going after.

<unk> doses versus just going after higher dose.

It might provide.

You put that question.

Increased tolerance.

Yes. So this was actually an initial approach in dialogue, we had at the end of phase II meeting because our last data set showed that five was rather outstanding but even the agency pointed out that are fixed and three milligram are actually quite good we showed improvement in symptoms, we showed lung function.

<unk> and we showed a.

A reduction of about 49% in the three milligram arm.

<unk> was.

It would be good to also interrogate that dose because it provides a backup.

Two five milligram for example, we see any emerging toxicity now we haven't seen any toxicity with any of our high dose any of our doses from the last trial, but let's also understand that that data set had less than 10 patients and are now we're getting up to close to 90 patients in arm. So.

There is a possibility of course that.

Safety at anytime might emerge as you start to look at more and more patients.

By having the three milligram dose it also de risks.

Any potential safety emerging safety signal that might.

And this has occurred I've had this occur in another program at previous company, where we backup dose. It was good that we actually had it in there because there were some tolerability issues and they allowed the lower dose to get approved. So this was something actually at the behest of the agency I actually thought it was a good idea.

It's the reason why our numbers have bumped up.

Previously I was telling investors with one dose and one placebo trial could probably be adequately powered at somewhere around 220 230 patients. When you have this additional arm and you still want to be over 90%. This is how we get closer to $2 64. So I think it's a combination of derisking for a potential.

That.

May or may not.

Emerge, we don't think it will and it gives us another shot on goal.

Okay. Thank you.

And.

How about the <unk>.

Hi.

So.

Any sense.

So from clinical trials Dot Gov information.

Looks like that.

The trial is.

We expect to complete in late 'twenty early 'twenty five.

So is that the kind of ballpark.

That.

If you kind of expecting the study to complete.

And also related to that.

For the other.

Programs.

As a reminder, CHP.

Would you be expecting to complete.

So good trial.

Before embarking on phase II for the other programs are.

The two programs sequence somewhere in between as far as timeline. It goes okay.

But at this point I'll answer the second part first.

At this point, we're focused on this one indication so while we have some encouraging signals.

With.

Additional ILD indications right now we're focused on this trial.

And focusing on getting it done when you look at Quintiles Dot Gov.

We have to put down something this is our best early estimate, but as we get into enrollment.

Are you able to look at that and say is that does that.

Does that timing still make sense should it be pulled in.

Should it go out further this will be predicated on how we do here it really over the next six months, but.

Most sponsors have to put something in early estimate and I think we have that for something like January 2025, right now.

Okay. Thank you and I guess my last question is.

Uh huh.

About the cash runway.

I haven't seen that guidance number.

The press release, just want to make sure im not missing anything.

You got it the cash runway.

And also.

Now that you are pursuing to 810 development.

Much of additional kind of.

Yeah.

Pension that you kind of expect from that in terms of cash from working.

Working on 12 months ago.

Yes.

We don't typically give us a cash runway because we look at it by project.

Like we said during the script.

We do have financial and strategic plans to be able to get through the data.

Read out for <unk>.

That's using our current cash will be any milestones from Kieran.

And then also use.

<unk>.

That's correct equity vehicles that we have out there right now.

We're saving some money from not doing 28 <unk> in the clinic like we just discussed.

Al.

The types of trials just generally typically are may be around 10 million ish, but it's more that just the cost of the trials. It's more of a time that does take.

Overhead.

Okay.

To continue running now.

That period.

Two.

Yeah.

And I'll just reiterate.

We're still retaining that value for 2018, so any any IP.

That's the other reason, if we talked a little bit about.

We had some patent language in this script, we're still retaining that value any data. That's also coming out of these potential collaborations.

So I think it's a really smart way for us to move things forward in the hands of experts spend less cash ourselves, but still retain that upside should we see signals in those.

Neuroendocrine phenotypes.

Okay very helpful. Thank you very much.

And one moment.

And our <unk>.

Last question will come from Kumar <unk> of Roth. Your line is open.

Got it thanks for taking my questions.

So with regards to the clinical trial site from the phase II trial.

Are you seeing some of.

Those sites coming onboard in the phase III trial.

And also your confidence about the side effect profile.

So what are your expectations in terms of the dropout rate.

Thank you.

So the trials. Thanks Kumar for the question for the trials sites that were previously involved.

We are seeing obviously good.

Take initiation.

Many of these were all centers in the U S and those that were involved previously obviously are very very excited about participating in the next trial. If you look at our chest publication.

Can look at each of those investigators on that publication all of those sites are going to be what I would consider our lead sites.

Some of these are bulky academic institutions, but even some of the timelines of approval has been rather quick in my estimation on how quickly we're moving things forward. That's because we have good data that's because we have.

The data that we can talk about and those local ethics and IRB committees I think our team is doing a really really good job, but I also have to tip my hat to those institutions that they are also responding quickly because they want to get patients into this trial and I know many of these centers are also prioritizing our study over.

Even any other sarcoidosis smaller trials that are out there early phase trials. They realize a late phase trials like this is really really important.

So I think thats.

That's the key you also asked a question about dropout.

With $2 60 for the estimation, we have here and what we built into the power calculations is.

7% to eight patients per arm.

We have that kind of cushion so.

I want to be at 240 patients.

So the worst case scenario here is.

24 patients or so eight per arm and then that would actually not impact the power calculations as long as we stay within that and other than.

Other than reasons outside of our control.

Sometimes there is some operational reasons, we do not expect anyone necessarily to need to drop out to go back to say standard of care because thats written into our protocol.

Folks are not doing well they can go back up on their steroids. In fact, we want that to happen because we think that's going to happen at a much much much more greater rate in the placebo population. So nonetheless, we still have a cushion.

As I said seven to eight patients per arm.

Dropouts.

Very helpful. Thank you so much.

Sure.

And I'm showing no further questions I would now like to hand, the call to Sanjay for closing remarks.

Well I want to thank everybody great questions today lots of questions. We appreciate it.

Really staying obviously laser focused here on the <unk> trial I appreciate a lot of updates today strategic.

Decisions that we've made and look forward to interacting in the near future and we really thank everyone's support listening on the line here our investors. Thank you so much.

Ladies and gentlemen. This concludes today's conference. Thank you for your participation you may now disconnect.

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Good afternoon, ladies and gentlemen, and welcome to the a tier pharma third quarter 2022 conference call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will be given at that time. As a reminder, this conference is being recorded for replay purposes. It is now my.

Pleasure to hand, the conference call over to Ashley Dunstan.

Powers director of Investor Relations and corporate communications.

Mr. Dunn Mckenzie you may begin.

Thank you and good afternoon, everyone. Thank you for joining us today to discuss <unk> higher third quarter 2022 operating results and corporate update we are joined today by Dr. Sanjay Shukla, our president and CEO Ms. Jill Broadfoot, our CFO and Dr. Leslie Nagel our V. P of research on the call Sanjay will provide an update on our corporate staff.

G, including our clinical program for Epic Ahmad and research and Discovery program Jill will review the financial results and our current financial position before handing it back to Sanjay to open up the call for any questions before we begin I would like to remind everyone that except for statements of historical facts. The statements made by management and responses to questions. On this conference call are forward.

Looking statements under the Safe Harbor provision of the private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward looking statements. Please see the forward looking statement disclaimer in the Companys press release issued this afternoon as well as the risk factors in the company's SEC.

Clings, including in our most recent annual report on Form 10-K subsequently filed quarterly reports on Form 10-Q and in our other SEC filings undue reliance should not be placed on forward looking statements, which speak only as of the date. They are made as facts and circumstances underlying these forward looking statements may change, except as required by law a tariff on my desk.

Any obligations to update these forward looking statements to reflect future information events or circumstances, I will now turn the call over to Sanjay.

Thank you Ashley.

Good afternoon, everyone and thank you for joining us for our third quarter 2022 results conference call.

The third quarter saw the initiation of.

A global pivotal phase III study.

Our lead therapeutic candidate <unk> <unk> in patients with pulmonary sarcoidosis.

Most prevalent form of interstitial lung disease or ILD.

We dosed the first patient in this study in September .

Meeting aggressive timelines and guidance.

Current market conditions.

We intend to focus our resources on prioritizing up Sofia.

Which is our highest value program to ensure a timely and successful completion of this study.

As we begin I will summarize a few additional highlights since we last spoke in August .

We announced the publication of results from the Phase one B study.

Study, so kind of modern patients with pulmonary sarcoidosis in the peer reviewed medical journal chest.

We presented a poster at the European respiratory Society or Drs International Congress on findings for an antibody for immunohistochemistry detection of Northland to or MRP to in patient tissue samples.

<unk> is absolutely Paramount binding partner and these findings suggest that this antibody may provide an extremely useful clinical tool potentially heating in patient selection stratification.

We received FDA fast track designation for Sofia demand for the treatment of systemic sclerosis.

SSC or scleroderma associated ILD.

We announced a research collaboration with dual systems biotechnology.

A company specializing in custom.

<unk> gnomic to identify and validate 10 target 10, new target receptors.

Four trna synthetase from our intellectual property or IP by 2025.

This collaboration is a way to potentially accelerate drug discovery efforts and identify new drugs from our platform.

And finally.

We received a notice of allowance from the U S patent and trademark office for anti <unk> monoclonal antibodies, which is the first to be granted to our IP state for this program.

We've experienced another quarter of crisp operational execution, both internally and in cooperation with our partners and collaborators.

And we anticipate a strong finish to the year.

Now, let's focus on some more specific updates around our clinical program for Epsilon Cinemark.

As a reminder, absent Fairmont is a first in class immuno modulator for fibrotic lung disease.

So <unk> is a novel FC fusion protein based on the naturally occurring splice variant.

Of the lung enriched trna synthetase Hearts fragment.

Downregulates aberrant immune responses and inflammatory disease state.

So <unk> has been shown pre clinically to down regulate inflammatory cytokine and chemokine signaling.

And reduce inflammation and fibrosis.

<unk> two receptor is up regulated on key immune cells during active inflammation.

And as enrich and inflamed lung tissue.

<unk> bind selectively to MRP too and therefore has the potential to normalize the immune system, serving to resolve inflammation and prevent progressive fibrosis.

Thereby stabilizing lung function and alleviating morbidity and mortality.

We're developing <unk> as a potential treatment for patients with ILD, a group of rare immune mediated fibrotic lung disorders.

Our initial ILD indication is pulmonary sarcoidosis.

Sarcoidosis is the most prevalent ILD and is characterized by the formation of Granulomas, which can occur in any Oregon.

But predominantly affects alone.

If left untreated this can lead to irreversible scarring of fibrosis, which greatly increases the risk of death.

We estimate that there are close to 200000 patients with pulmonary sarcoidosis in the U S and around 150000 in the major European markets.

With another 20000 in Japan.

Up to 75% of patients required treatment for their disease.

And approximately half of these will have progressive disease despite treatment.

Around one in five of all patients will go on to develop lung fibrosis.

First line treatment is typically corticosteroids, which may effectively control symptoms that are associated with severe debilitating side effects.

Particularly with chronic treatment.

And patients unresponsive to steroid treatment cytotoxic immunosuppressants or biologic immuno modulators, maybe but are also known to cause serious side effects.

The use of all of these therapies is imperative and not supported by current clinical evidence standards.

We believe the addressable market for <unk>.

Three geographic geographies mentioned is around 200000 patients.

Even with conservative assumptions this represents a significant market opportunity in sarcoidosis alone.

<unk> has received orphan drug designation and fast track designation from the FDA for sarcoidosis.

We see upside potential for our Sofia demand and other forms of ILD.

This includes indications such as scleroderma related ILD.

We have also garnered FDA orphan drug and fast track designation.

Also other connective tissue disease disease related ILD.

And chronic hypersensitivity pneumonitis among others.

These diseases share overlapping immune pathology with sarcoidosis.

And others, having limited treatment options and absolute <unk> has demonstrated efficacy in animal models.

Sure.

These diseases.

Taken collectively this represents a multibillion dollar market opportunity for absolute fit a modern ILD and.

<unk> is poised as a front runner front runner and the expansive opportunity.

Now, let's recap the data we have generated perhaps some <unk> and some updates on the current <unk> study.

In September 2021, we reported clinical proof of concept for <unk> based on positive results from our phase <unk> study in pulmonary sarcoidosis.

The study, which included a forced steroid taper demonstrated safety tolerability and consistent dose response for <unk>.

Key efficacy endpoints and improvements compared to placebo.

Including measures of steroid reduction lung function sarcoidosis symptom measures and inflammatory biomarkers.

Just this past week the full results from this study were published online in the peer reviewed medical journal chest.

With the Dr. Daniel Culver Chief of pulmonary medicine at the Cleveland Clinic service thing as lead author.

This marks the first peer reviewed publication of clinical data, perhaps at <unk> or.

Or for that matter any trna synthetase derived therapy in a major medical journal.

These data indicate that <unk> is providing substantial benefit to patients.

Proving lung function and symptoms of cough.

Jordan, it's a breath and fatigue.

All while reducing their toxic steroid burden.

According to medical experts.

First randomized placebo controlled trial of any therapy for pulmonary sarcoidosis.

Demonstrate effects on physiologic and quality of life measures concurrent with steroid reduction.

With the full data set now available for review.

We expect this publication will generate additional education awareness.

And support for <unk> demand, among the specialists and generalists provider community, particularly as we are currently enrolling for esol fit.

<unk> is a global pivotal phase III randomized double blind placebo controlled study to evaluate the efficacy and safety of <unk> in patients with pulmonary sarcoidosis.

It is a 52 week study consisting of three parallel cohort.

Randomized equally to either three milligrams per kilogram or five milligrams per kilogram of <unk> or placebo.

Most intravenously once a month for a total of 12 doses.

The study intends to enroll 264 patients with pulmonary sarcoidosis at multiple centers in the U S Europe and Japan.

The trial design incorporates a forced steroid taper and the primary endpoint of the study is steroid reduction.

Secondary endpoints include measures of lung function and sarcoidosis symptoms.

We've dosed the first patient in the study.

Several sites in the U S open for enrollment.

We expect additional sites to open in the U S.

Later this year.

I will remind you that this is a global study.

We held a productive meeting with European investigators during GRS in September .

And we now have rapidly achieve regulatory approval to proceed with the study in a number of countries, including the UK, Netherlands, France and Spain.

We anticipate sites opening for enrollment in those countries in the coming months in early 2023.

Finally, our partner <unk> pharmaceutical has also completed submission of the clinical trial notification or Cts in Japan, and we could see a center. They are open for enrollment by the end of the year.

We're highly encouraged by the rapid pace of this progress.

As it permits us to initiate the study in those regions and signifies our alignment with these regulators on the trial design <unk>.

Including the steroids bearing primary endpoint.

I want to give kudos to our regulatory group led by Dr. Bob Ashworth for skillfully navigating towards these regulatory approvals.

<unk> is expected to be the largest interventional study for patients with targeted to date.

There is also the largest study that <unk> undertaken in the history of the company.

We're laser focused on ensuring that this study receives the resources it requires and we intend to focus.

Our resources on Epsilon to ensure its completion.

So shifting to our preclinical and discovery programs, let's discuss some of the progress with our pipeline.

This concludes <unk> 2810, or 28% and today.

We'd like to provide a strategic update regarding this program, which we have in advance to be phase one already.

Due to current market conditions, and the need for prioritization of capital most importantly, focusing our resources on the <unk> study.

We've made the strategic decision not to use our internal resources to initiate a phase one study of 28% this year.

We intend to look at other potential non dilutive avenues, including academic collaborations.

Or other funding sources to bring this program forward.

Multiple academic centers are particularly interested in advancing 2018 and rare aggressive cancers, where many patients.

Main unresponsive to currently available treatments.

Such as neuroendocrine prostate and pancreatic neuroendocrine tumors.

Recent published literature regarding the role of <unk> in these types of cancers and interest from these centers have encouraged us to consider interrogating an anti <unk> agent such as 2018 in these indications.

This includes an exciting publication recently from one of our key collaborators Dr. <unk> data and his colleagues from the University of Nebraska Medical Center, indicating.

The role of <unk>, two in promoting metastasis and conferring therapeutic resistance in neuro endocrine like prostate cancer.

Which outlines the potential for the therapy.

In this aggressive tumor type.

As a reminder, 20 attendance fees, one ready, having completed IND, enabling activities, including GMP manufacturing and <unk> Tox studies.

And we have been granted allowance from the U S patent and trademark office for the patent for anti <unk> antibodies, which covers us for 2008.

I'll close with reiterating how excited we are.

Our trna synthetase platform than what it has yielded thus far as we get closer to our mission of translating our trna synthetase biology.

Enter new therapeutics for fibrosis inflammation and cancer.

We've advanced <unk>, which is derived from a fragment of histidyl trna synthetase or hard in.

<unk> phase III study.

Meanwhile, we've identified and validated the.

The receptor target for fragment of another trna synthetase, alanyl trna synthetase for ours and.

And we expect to reveal the receptor of yet a third fragment. This one from Astra deal trna synthetase or darts.

In the near future.

I'll now turn it over to our Chief Financial Officer, Jill Broadfoot to review our financial results.

Thank you Sanjay we ended the third quarter 2022, with $79 6 million in cash.

Cash cash equivalents and investments.

<unk> and development expenses were $9 9 million for the third quarter, 2022, which consisted of product development and manufacturing costs.

So the asphalt cinemark in 2008 to 10 programs as well as startup costs for the phase III.

General and administrative expenses were $3 6 million for the third quarter 2022.

Common shares outstanding were approximately $29 million and fully diluted shares were $34 million as of September 32022.

From a balance sheet perspective, we are comfortable with our current cash position, which we believes that enables us to carry out the most meaningful value driving catalyst for the company.

While running a large global phase III study in a rare disease, such as App soft it is capital intensive we do share a portion of the cost with our partner <unk>, who is responsible for the cost of all operations and patient costs in Japan and purchases drug supply for mask with a small market.

And as a reminder, under our agreement with Karen we are eligible to receive up to an additional $165 million in milestone payments of which the majority of our development and regulatory related.

As we stated on the call today, we have made some important decisions around our pipeline that will allow us to better manage our cash at this point in time, we have a financial and strategic plan for the company to fund operations to the data readout for this plan.

<unk> contemplates our current cash balance the potential for milestones from Kieran and potential proceeds from the use of our existing equity vehicles.

Now I'd like to turn the call back over to Sanjay before we open it up to Q&A.

Thank you Jill.

We are highly dedicated team.

With a track record of exceptional execution, and we continue to make outstanding progress with efficient use of capital.

We understand that the markets have been challenging as of late.

And certainly know that they do not.

And any way adequately reflect the intrinsic value of the company.

Including the data and progress we've generated for our Sofia demand.

Considering its stage of development as of late phase asset.

And its potential to address a multibillion dollar market.

Yes.

The prioritization, we've discussed today provides us with the ability to ensure adequate resources to successfully advance the highest value driving catalysts for the company.

I'll close with a comment.

Recently from one of our top shareholders.

Who told me HR as a platform company, that's generating transformative Reese.

Our research and clinical opportunities.

From our trna synthetase biology of space.

This is a company that I think.

Is poised right now to be a leader in.

An area of interstitial lung disease, where as I mentioned, we are the front runner.

So we appreciate your interest continued support at.

At this time Jill.

And I will be happy to take your questions. Thank you.

Ladies and gentlemen, as a reminder, if you would like to ask a question. Please press star one on your Touchtone telephone.

Again for any questions. Please press star one line.

Sure.

And our first question will come from Gregory <unk> of RBC. Your line is open.

Hi, This is <unk> on for Greg Congrats on the progress and thanks for taking our questions maybe.

Maybe first on the phase III trial.

Some companies in our space are.

Some clinical trial conduct slowdown could you just provide some color on what you are seeing around site activation and <unk> cadence is what is your confidence level and the guy that timeline of the phase III trial. Thank you.

Sure I appreciate the question. So it's quite early to necessarily get into projections and the trajectory, but what I can tell you is.

The excitement from the pies worldwide.

<unk> been waiting 20 years.

Sometimes longer for a therapy like this to get to this stage. So certainly from that perspective, I think you can look at the pace of our regulatory approvals.

And even the fact that we were able to get a patient enrolled basically about three months from getting the green light from the FDA. This speaks to the rapid sort of interest and uptake.

To enter our trial I also think the data we produced is checking the box in all the areas that these experts have been waiting for probably going back really 50 years, a drug that can reduce.

<unk>.

Improved symptoms improve lung function in all doing that while reducing steroid this has never been seen before.

So what do I anticipate.

<unk> fast start I'm glad we've started fast with the first patient.

I also have seen the quick pace of regulatory approvals.

I will be at three sites next week.

So I think I think it's something it's off to a fast start here, we're going to have to watch to see is this is the largest.

Sarcoidosis trial ever how.

How we really progress here and I think I'll have a better estimate of that once we get a good 30, 40 centers up and let's allow them to enroll let's allow them to enroll for a few months I think our publication is also really really important this.

This is the first major sarcoidosis publication from our clinical trial, I'd say going back to the Infliximab data in the 2000 and.

So this is a field that is hungry to actually interrogate pesto <unk>. They like the initial data and I can tell you that patient certainly are responding well.

In that we are really trying to address their steroid burden.

<unk>.

I will get back to you to see how we're doing here, but early signs are very very encouraging.

That's great. Thanks for the color and then maybe secondly could you talk a little about your latest development strategy Escola Derma ILD and what do you see as the key differentiation of the mechanism of action that could drive clinical potential in this indication.

You.

Great, Yes, so scleroderma I think it's something that.

And honesty as an adjacent condition we are seeing.

Number of Pulmonologists and Rheumatologists have theyre seeing our <unk> data and sarcoidosis become very interested Conversely, we've also received maybe rather surprisingly some some nice designations early from the FTA scleroderma ILD represents probably the worst form of <unk>.

<unk>.

It's where some of the morbidity and mortality.

Really.

Really quite dramatic and these patients don't have treatment options.

While we have.

A good kind of feel from patients and providers and regulators we have to be careful about thinking about how do we.

Keep our eyes focused on sarcoidosis first.

So at this point I think we're really keeping eyes on sarcoidosis, but it is really encouraging that based on really our data and even going back to our preclinical data we have animal efficacy showing up Sofia demand can impact sclerodermatous plaques and lung inflammation.

So that translation is there so.

So the story is there but right now we are staying focused on sarcoidosis last thing I'll say is we are looking more closely at <unk> expression in scleroderma patients. There's anecdotal evidence that <unk> is quite up regulated and some of those sclerodermatous plaques, but I think we have some time to to <unk>.

Look more closely at that.

But certainly that is a opportunity that.

If we had if we had abundant resources and infinite resources certainly is another large market opportunity sitting there for us.

That's great. Thank you very much.

One moment.

And our next question will come from Joe <unk> of HC Wainwright. Your line is open.

Hey, everybody. Good afternoon. Thanks for taking the question. So first just a little more on <unk>.

Obviously, it's early.

Just wanted to see I am not implying these are any rate limiting steps will wanted to get your sort of early views on how.

Do you view, the ease of screening patients and any particular geographies even in just the U S that you might see outperform even before the European sites come on board.

Yes.

Yes, Hi, Joe Greg Great question, we've made some tweaks to our protocol based on our last study that I think are going to address.

Some of your points here.

Number one moving into Europe and Japan.

There tends to be slightly less.

Slightly less steroid administered in those patients that could have to do with.

The physiology of those patients.

But also.

There is a larger cohort of African African Americans are black patients here in the U S.

Typically those patients have.

More severe diseases that may require more steroids with that in mind, we've lowered the threshold and this current protocol to allow entry.

At seven five milligrams as opposed to 10, we think this is going to help us enroll and better fits the sort of treatment paradigm of Japan, and Europe , where they tend to use a little bit less so I'll start there and say thats going to help us I'll also say that compared to the last study where pet scans were used as an inclusion criteria.

And have now fallen out of favor five years later, we're now using <unk>, which is going to be a little bit easier to administer and readout more commonly viewed as a better instrument to detect fibrotic patients or not we want to exclude those patients that are highly fibrotic and bring those patients in that are inflamed.

<unk> is I would say more validated instrument than pet scans. This is going to help us.

So I think those are too early.

Sort of tweaks that we've made in this protocol to allow for an easier entry into our trial and then the last thing I'll say is our data from the last study. The fact that we showed steroid reduction and we are the first therapy to really ever show the ability to improve symptoms and lung function, while reducing steroids. This is really important to.

So now that there's that experience from that loss trial.

Patients are very very interested in our therapy, because we're not just showing nominal improvement in one or two end points, it's really all the endpoints and the one they care. Most about is can I get off steroids or can this help me reduce my steroid burden, that's going to be a real attractive asset for us as we think about it.

Enrolling worldwide.

That's helpful. Thanks, and then.

When you just look at the especially in this current environment, it's glad to see you guys being thoughtful about your resources. So.

How would you describe.

How much you're putting your background overall in RP to work.

Not on the back Warner Backburner, but just sort of.

Pausing, a little bit from a cash spend standpoint.

Yes, I mean, I think 28 10 is something that frankly.

When I think about it as opportunity.

We've landed on these indications.

This is the best fit for 2008, the moving forward these really rare.

Third line cancers, and especially these neuroendocrine phenotypes.

Really the indication where it makes most sense for 28 10 to advance now when you think about these rare cancers.

They can be slow to enroll certain academic centers are specialists in there.

These sort of rare or types of cancer. So it makes sense for us to partner with those academic experts and because these are rare cancers, we actually have more access to non dilutive ways of funding.

Because because there is money out there for these sort of rare cancer. So it's an intersection of our data and number one pointing us in that direction, but these are.

Cancers that we should actually target with 28 10, and Conversely, It allows us to also work with academics, which at the end of the day serves us well under these current conditions.

So it's an intersection of really I think our data the opportunity with these experts in these rare cancers and then the fact that.

Given current conditions, we're grateful that we're probably going to have avenues at these centers.

So I think it's it makes sense for us.

Based on a lot of different factors to progress the program.

Side by side with these centers.

And Conversely, if of course, it does help us focus on <unk> as well.

Right. Thanks for the color Sanjay.

One moment.

And our next question will come from her Taj Singh of Oppenheimer. Your line is open.

Great. Thanks, Sandeep and team for all the updates.

Could you just kind of a different kind of question I think it might be or at least with this but.

First question is.

We kind of we did a survey of high prescribing physicians pulmonary sarcoidosis everywhere.

I mean, we shouldn't have been we were shocked at just how much they use steroids and how much they want not want to use sterile 90, plus percent, 100% use steroids. The 90 plus percent want patients to get off steroids are reduced steroids.

This burden right and you've talked about all of the patient numbers.

Go into a potential lapse, we'll put them on what about on the value side.

I mean.

Has any.

Have you done preliminary work as to what could be.

Comps for <unk>.

Towards the data.

We congratulate itself in phase III and it was to get approved what sort of comp. So are we thinking about.

Assuming the drug gets approved I, just kind of follow up questions. Thank you.

Yes.

We have spent some time this last quarter.

Looking at a little bit more closely at that we've done our own internal analysis excellent with an external firm that has interviewed experts and done some early payer work that you might be hinting too.

Our estimates were a little light and I think we're all learning that first of all more patients are on steroids and we expect it's a bigger issue and patients want to get off steroids, Conversely from a pricing standpoint.

Most experts have come back to us and say the pricing of this drug.

If we start to see these kinds of steroid reduction effects, while also improving lung function improving quality of life.

It could be upwards to kind of what humira is getting.

That's probably on the high end, but you look at those drugs like <unk> and as Britt.

These are drugs that generate.

<unk> is $1 of revenue for Roche in BPI.

Our drug would I think fall into a similar pricing bucket look those drugs just reduce the they reduce the lung function decline.

Our drug is <unk>.

Preserving and improving lung function, it's improving symptoms.

Which of those drugs are not doing and doing so while removing steroids. So I think we're very confident now that from a pricing standpoint.

Would approach some of those similar Ips drugs, which is why a lot of the modeling estimates not only internally, but also with some of you guys have been actually changing.

So I do feel better again after our data that it is generating a bit more confidence.

The pricing of it.

The potential pricing of the drug could be much higher than we initially expected.

Yes, no no thats, great Sanjay and then the other question.

Have is.

<unk>.

I'm, sorry, you're asking there was a lot of data presented by larger companies, but I was a little surprised.

On the battery, but just how much the walls around your presentations, even though I think you had far greater presentation at Ats.

What are you thinking in terms of strategic sort of view.

There seem to be a pause.

As <unk> being kind of a small cap company with a product that could play.

Play really well to a multinational company wants to take this product harbinger.

Many countries many geographies of the world what are you thinking if I can churn in that regards excellent questions.

Yes, I think it's a factor of a couple of things first the data needs to just get absorbed I mean, we put it out at Ats.

It takes a minute to kind of get worldwide. I think the publication is really going to help us and we've already seen even in a couple of days it's been up.

We have.

New interest from us.

From other parts of the world.

Pulmonologists are busy they are managing a lot of conditions.

Outside of the specialists. This is why I said, the generalist will start to pick up on this the other thing Thats happening is we're seeing a contraction in the <unk> space with a number of companies.

Kind of moving out of the space. They are finding their therapies are not working as well in preclinical and early phase testing, you'll see larger companies.

Moving out of the space. So this is why we feel like <unk> tire is getting that buzz that you picked up on at Barcelona that our therapy is doing things previously not seen in sarcoidosis with other therapies.

And we are the furthest along and combine that with some competition kind of.

Going away here, we think that can help us certainly enroll.

And again, we could be we could come out of this sort of at the top of the wave here.

In a few years is what I think is a leading <unk> company last thing I'll say about IRS.

And I think you picked up on this interstitial lung disease is where asthma and COPD was about 15 years ago at the IRS conferences around 2000 2005.

Better new steroid sparing therapies where needed.

And they came out Lama LABA.

Some of the anti muscarinic things like that for for asthma and COPD.

Now the shift for respiratory experts is how do we get better drugs and Iot you have seen United do some things with.

Pulmonary hypertension ILD.

But right now we are.

Kind of the leader right now for socket, we certainly offer sarcoidosis, but our therapy is something that could be really useful in a number of those other conditions. This is why we think it's a multibillion dollar opportunity and were hopeful to get noticed.

More and more in the coming years as we.

Get this data out.

Great. Thank you so thanks for the questions Anthony.

One moment.

Our next question will come from Edward <unk> of Piper Sandler Your line is open.

Great. Thank you very much we appreciate the update and I really applaud the execution, especially on the phase III understand the focus.

One of the things I've always appreciated Sanjay about tires youre close relationships with the academic labs, I think it's a really smart way to be.

Since 2010, my question has to do with sort of the two water utilities.

The platform.

And are there opportunities to do partnerships.

With biotech soar.

Big farmers around some of these other areas.

Or is the goal really to do a lot of the early work yourselves and then do more tons of product type deals in the future. So I appreciate you taking the question.

Yes, I do think thank you Ted for the question I do things, we absolutely <unk> data is clearly validated our platform and we're seeing that.

Through interest with.

Really across the spectrum.

Academics other companies really digging in.

Our dual systems collaboration is really about taking the lid off of our synthetase or state. We think we can do it faster better and frankly cheaper now with this collaboration.

As we crank out new targets and thus far this summer we had a new target with fibroblast growth factor coming out of <unk>.

One of our synthetase targets.

I think we're going to have Optionality now we're going to have the ability to say hey, do we want to take some of these forward.

We're not going to be able to take all 10 forward ourselves, let's just be honest not all 10 are going to be necessarily winners, but that's the other thing we'd like to be honest here at box at a tire.

But I think what's going to happen here is we're going to have an opportunity to look at these.

Frankly.

Engage and potential partnerships.

Another thing I am load to talk too much about but I do think that now we're at a position where we generated more interest than ever and a tire a tower was very much a show me something story.

We've done that now we have a process now we even had a partnership with a group out of Zurich.

That can I think yield a number of pipeline opportunities and I would say some of these will keep kind of under our umbrella others.

We're going to have opportunities to partner.

And I think that's something to expect here.

And then prepare for in the years to come.

Great. Thanks, guys.

One moment.

Okay.

And our next question will come from Yale Jen of Laidlaw <unk> Company. Your line is open.

Good afternoon, and thanks for taking the questions.

Due to your <unk>.

We saw sort of focusing.

Do you still.

We'll conduct clinical preclinical study.

Some new targets or or what did that approach.

<unk> was also showing there.

Ajay as well.

Thanks, Yes, no I think this is really related to 2008 to 10 in the clinical program.

You can imagine moving into clinical studies.

Where it really starts to get expensive. We have we have a mechanism and now a process that certainly from a discovery and preclinical standpoint.

There is no slowing down in fact, youll see acceleration and outputs.

But again.

We are very very capital efficient with some of those.

Those efforts, it's really moving into the clinic, where right now.

Absolutely fit being the largest in our late phase program.

We just thought it was smarter for us to really really reiterate and focus resources, there, but from a pipeline and discovery standpoint. No. These are these are all opportunities that we're going to still pursue.

For 2008, and we simply are taking a different strategy with that which I think will do two things number one it will put it in a home and perhaps with some.

Academic groups that frankly will be able to move it forward it had virtually.

Little to no cost to us so we can assume advanced therapy that way.

But but I think the game plan right now is to generate certainly more pipeline opportunities and then we can decide we can see I've always said, let's look at the data and now let's figure out how we want to move. This forward. It's an approach we've always taken we want to be data driven and I think from our pipeline.

<unk>.

No there is no contraction there.

Okay, Great. That's very helpful. As we talk about 2008.

Do you have some estimate in terms of.

The dollar could be saved.

Now the <unk>.

Clinical work over the next few years.

Sort of a rough estimate on that.

So.

How many dollars could be saved right yes.

I don't think we have I'll, let Jill also answer here.

Wouldn't necessarily look at heart estimates here because one of the things is.

These are rare tumor types, which I think one thing we just have to call out here. It can take much longer to enroll in these rare phenotypes.

So this is another part of our strategy that who is best.

Prepared who has these sorts of patients and access to them.

So I think from a time perspective, that's where we actually saved quite a bit from just a rough dollar perspective, Joe do you want to add.

Yes.

Dollar perspective, it's not as significant and obviously it depends upon the trial design, which we do.

Looked at a couple of different trial designs, depending upon how we wanted to approach that.

You can say on average from clinical cost maybe.

Around $10 million or so, but it's really what sanjay was talking about.

And how long that takes.

So that $10 million doesn't really.

All of that overhead and distraction to the company as well that can occur over that.

Two here.

That's right that's right yeah early phase clinical oncology trials can sometimes.

There's a number of hurdles to move through.

It is also a rare phenotype, but roughly speaking.

I think $10 million for a program like that.

As a comp that most companies would look at there.

The distraction part is.

Yes.

Wouldn't necessarily hit it we're able to do a lot of things here at <unk>, but I think this is this is the best thing for us and frankly, putting it in the hands of folks who maybe have these patients with neuroendocrine phenotype. They are quite excited to move.

The asset forward there and it also comes with the benefit that we.

We may be able to tap into funding because we are focusing on these more rare and ultra aggressive tumor types.

Okay, Great and maybe the last question here is that in terms of.

The study in Japan.

Do you have.

How are you guys going to reveal in terms of property the size.

And then maybe any other colors.

That part of the trial and thanks.

Yes, I would say.

Roughly speaking.

No.

Regionally, Japan regulators typically like to see at least from a global trial at least about 10% of the patients come from that region.

An indication of rare disease like this.

Partners are piggybacking off of our global data.

So, it's obviously difficult to enroll and power a trial in a specific region like Japan.

But I would anticipate right now early on.

Somewhere around 10% of our patients.

We will need to come from Japan somewhere in somewhere in that number around that range.

Okay, great. Thanks appreciate that and.

Okay. Congrats phone some so good that they have made.

<unk> made so far.

Thank you.

One moment.

Our next question will be from Sean Kim of Jones trading your line is open.

Yes, hi, Thank you for taking my questions.

I apologize if I'm repeating questions Dennis previously.

For the phase III.

Trial can you kind of remind me what the statistical plan, including the statistical powering also how much of a separation.

Yeah.

And that has been baked in to that kind of calculation.

Sure sure happy to do that so our trial is powered with 264 patients.

Three dose arms Theres, a five milligram or three milligram and a placebo arm in each each arm is 88 patients.

We powered this trial.

Over 90%, 92% to be exact for for either.

The three milligram or the five milligram dose of showing statistical.

Statistical superiority to.

To placebo. So we have essentially two shots on goal with either of these two.

Much higher clip typically you want to power these studies at least 80%.

We've actually done them both.

Both of these.

Doses at over 90%.

In layman's terms, what are we trying to show in steroid reduction in absolute reduction of somewhere between two five to three milligrams.

Difference.

As in our NRI is meaningful.

In the eyes of experts for example, if you have a 10 patient coming in at 10 milligrams and getting on Esso gets them down to seven and a house that's meaningful benefit.

It may not seem like a lot for us, but everyday removing two to three milligrams of prednisone.

This adds up.

Removing that.

Decreases the overall cumulative burden and over the course of six 912 months. This is going to help you with cardiovascular metabolic.

Newark neuro effects of what's steroids do so.

I hope that provides a little bit of color there.

Very well powered.

I'm a little bit.

Very particular about statistics, having having a background in that so I think thats something that we wanted to overpower if you will and we have two shots on goal to essentially show about that two and a half and three milligram difference.

Okay. That's very helpful. Thank you and I guess, just one follow up question on that is.

You have three arms.

$305 against placebo.

Yes.

Behind going after.

Doses versus just going after a higher dose.

That might provide care.

Put that kitchen.

Increased tolerance.

Yes. So this was actually an initial approach in dialogue, we had at the end of phase II meeting because our last data set showed that five was rather outstanding but even the agency pointed out that are fixed and three milligram are actually quite good we showed improvement in symptoms, we showed lung function.

<unk> and we showed.

A reduction of about 49% in the three milligram arm the view was.

It would be good to also interrogate that dose because it provides a backup.

Two five milligram for example, we see any emerging toxicity now we haven't seen any toxicity with any of our high doses of any of our doses from the last trial, but let's also understand that that data set had less than 10 patients and are now we're getting up to close to 90 patients in arm. So.

There is a possibility of course that.

Safety at anytime might emerge as you start to look at more and more patients.

By having the three milligram dose it also de risks.

Any potential safety emerging safety signal that might.

And this has occurred I've had this occur in another program at previous company, where we backup dose. It was good that we actually had it in there because there were some tolerability issues and they allowed the lower dose to get approved. So this was something actually at the behest of the agency I actually thought it was a good idea.

It's the reason why our numbers have bumped up.

Previously I was telling investors with one dose and one placebo trial could probably be adequately powered at somewhere around 220 230 patients. When you add this additional arm and you still want to be over 90%. This is how we get closer to $2 64. So I think it's a combination of derisking for a potential.

That.

May or may not.

Emerge, we don't think it will and it gives us another shot on goal.

Okay. Thank you.

And.

How about the timing and the sequence.

Different events.

From clinical trials Dot Gov formation.

Looks like.

The trial is.

Sure.

It's completed in late 'twenty early 'twenty five.

So is that the kind of ballpark.

Timing.

That should be kind of expecting the study to complete.

And also related to that.

The other.

Programs scored a reminder, CHP.

Yes.

Would you be expecting.

So good trial and see.

Before embarking on phase II for the other programs are.

The two programs sequence Sameer.

As far as the timeline goes.

But at this point I'll answer the second part first.

At this point, we're focused on this one indication so while we have some encouraging signals.

With.

Additional ILD indications right now we're focused on this trial.

And focusing on getting it done when you look at Quintiles Dot Gov.

We have to put down something this is our best early estimate, but as we get into enrollment.

Are you able to look at that and say is that does that does that timing still make sense should it be pulled in.

Should it go out further this will be predicated on how we do here it really over the next six months.

Most sponsors have to put something in early estimate and I think we have that for something like January 2025, right now.

Okay. Thank you and I guess my last question is.

About the cash runway.

I haven't seen that guidance number.

The press release, just want to make sure you're not.

Anything.

Have you got it the cash runway.

And also.

Now that you are pursuing to 810 development.

How much of additional kind of.

Expansion.

You kind of expect from that in terms of cash flow from now.

Working on 12 months ago.

Yes.

This is Joe we don't typically give us cash runway because we look at it by project.

As we said during the script.

Do you have financial and strategic plans.

<unk> plans to be able to get through the data.

Read out for <unk>.

Thats using our current cash will be getting milestones from Q.

Aaron.

And then also use.

That's correct equity vehicles that we have out there right now.

We're saving some money from not doing 28 <unk> in the clinic like we just discussed with you.

The types of trials just generally typically are may be around 10 million ish, but it's more that just the cost of the trials. It's more of a time that the tank and the overhead that is needed just to continue running now.

Period.

Two.

Yes.

And I'll just reiterate.

We're still retaining that value for 2018, so any any IP.

That's the other reason, if we talked a little bit about.

We had some patent language in this script, we're still retaining that value any data. That's also coming out of these potential collaborations. So I think it's a really smart way for us to move things forward in the hands of experts spend less cash ourselves, but still retain that upside should we see signals.

In those neuroendocrine phenotypes.

Okay very helpful. Thank you very much.

And one moment.

And our.

Last question will come from Kumar <unk> of Roth Your line's open.

Got it thanks for taking my questions.

With regards to the clinical trial site from the phase II trial.

You're seeing some of those.

Those sites coming onboard in the phase III trial.

And also your confidence about the side effect profile.

So what are your expectations in terms of the dropout rate.

Thank you.

So the trials. Thanks Kumar for the question for the trials sites that were previously involved.

We are seeing obviously good.

Take initiation.

Many of these were all centers in the U S and those that were involved previously obviously are very very excited about participating in the next trial. If you look at our chest publication.

Can look at each of those investigators on that publication all of those sites are going to be what I would consider our lead sites.

Some of these are bulky academic institutions, but even some of the timelines of approval has been rather quick in my estimation on how quickly we're moving things forward. That's because we have good data that's because we have.

The data that we can talk about and those local ethics and IRB committees I think our team is doing a really really good job, but I also have to tip my hat to those institutions that they are also responding quickly because they want to get patients into this trial and I know many of these centers are also prioritizing our study over.

Or even any other sarcoidosis smaller trials that are out there early phase trials. They realize a late phase trials like this is really really important.

So I think thats.

Thats key you also asked a question about drop out.

With $2 60 for the estimation, we have here and what we built into the power calculations is.

7% to eight patients per arm.

We have that kind of cushion so.

I want to be at 240 patients.

So the worst case scenario here is <unk>.

24 patients or so eight per arm.

Then that would actually not impact the power calculations as long as we stay within that.

Other than.

Other than reasons outside of our control.

Sometimes there is some operational reasons, we do not expect anyone necessarily to need to drop out to go back to standard of care because thats written into our protocol.

Folks are not doing well they can go back up on their steroids. In fact, we want that to happen because we think that's going to happen at a much much much more greater rate in the placebo population. So nonetheless, we still have a cushion of as I said seven to eight patients per arm.

Dropouts.

Really helpful. Thank you so much.

Sure.

And Im showing no further questions I would now like to hand, the call to Sanjay for closing remarks.

Well I want to thank everybody great questions today lots of questions. We appreciate it.

Really staying obviously laser focused here on the <unk> trial I appreciate.

A lot of updates today strategic.

Decisions that we've made and look forward to interacting in the near future and we really thank everyone's support.

Listening on the line here our investors. Thank you so much.

Ladies and gentlemen. This concludes today's conference. Thank you for your participation you may now disconnect.