Q1 2021 aTyr Pharma Inc Earnings Call

Ladies and gentlemen, does your operators speaking todays conference is scheduled to begin momentarily until that time your lines will again be placed on hold.

Ladies and gentlemen did your operator speaking then he's conference is scheduled to begin momentarily until that time your lines will again be placed on hold thank you for your patience.

[music].

Good afternoon, ladies and gentlemen, and welcome to day tire pharma first quarter 'twenty, one on one 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 my pleasure to hand, the conference call over to Ashley Dunston, H hires director of Investor Relations and corporate communications.

Sir you may begin.

Thank you operator, and good afternoon, everyone. Thank you for joining us today to discuss <unk> first quarter 2021 operating results and corporate update we are joined today by Dr. Sanjay Shukla, our president and CEO Ms. Jill Broadfoot <unk>, our CFO and Dr. Leslie Nagel, Vice President of research on the call.

Jay will provide an update on our corporate strategy, including our clinical program for <unk> T Y. Our 1923, Leslie will provide an update on our research and discovery programs and are appealing to including our preclinical program for a T Y R 28, and our Bispecific antibody program with our subsidiary Pangu Biopharma.

Joe will review the financial results and our current financial positioning beforehand to get back to Sanjay to open the call up 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 debt.

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 company's press release issued this afternoon as well as the risk factors in the company's SEC filings.

Crude and its included in our most recent annual report on form 10-K and quarter. It reports on form 10-Q, and you reliance should not be placed on forward looking statements, which speak only as of the day. They are made as facts and circumstances underlying these forward looking statements may change, except as required by law a tire 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.

First quarter 2021 results conference call.

2021 is shaping up to be an impactful year for the company.

In the first quarter, we made meaningful progress with our clinical preclinical and research and discovery programs.

We remain focused on advancing our lead therapeutic candidate <unk> 1923 from 19 to 23.

With enrollment completed in our phase <unk> clinical trial in pulmonary sarcoidosis.

Our initial interstitial lung disease or ILD indication.

We are tracking towards readout from this important proof of concept study.

Having gained key mechanistic insights regarding 1920 in total.

Inventory effects in patients from data obtained from our phase II clinical trial.

COVID-19 severe respiratory complications.

Look forward to the boardroom.

Expected in the third quarter of this year.

Furthermore, we generated additional preclinical data for <unk> 28 per.

Or 28, 10 or entitled Oracle in two or cannot be two antibody in preclinical development for cancer.

Let me summarize a few additional highlights since we last spoke in March.

We appointed leading sarcoidosis advocate, Andrew Wilson co founder and former President and member of the Board of Directors of the foundation from stock at Opus Research for SSR presentation advisor to the company.

In collaboration with the Echostar, we partition participating virtually.

Zero other than surgical.

Can you discuss the burden of sewage treatment and the need relief.

True.

We presented two posters.

The American Association for cancer Research preclinical.

Good day.

For 28 and models of Triple negative breast cancer.

Non small small cell lung cancer.

We entered into an agreement with one of the leading contract development and manufacturing organization or the manufacturer of 28 net.

To support the progression of 48 into clinical stage development.

Hey, good morning.

Our Hong Kong subsidiary together with the Hong Kong University of science and to achieve the milestone from.

The first year two year project funded in pharma.

I'll call it government innovation and Technology Commission.

To develop a high fleet growth.

Okay.

Our bi specific antibody targeting <unk>.

And finally, we promoted Dr. Leslie Nagel from Vice President of research Dr.

Dr. David will serve as a member of our executive leadership team managing research and sorry for the operations.

We're highly encouraged by what we've accomplished this year, thus far and look forward to building.

And discovery pipeline from our novel Biology platform as we move forward this year.

Let's begin with our clinical program from 19 to 23.

We are developing nicely in 'twenty, three as a potential treatment for severe inflammatory lung.

But what are you doing as a potential first in class immuno modulator that downregulates vigilant aberrant immune responses it is true.

Absolutely.

Thank you.

Has been shown pre clinically to down regulate inflammatory excited.

Hello.

Andrew inflammation and fibrosis.

<unk> is up regulated on <unk> sales known to play a role in inflammation.

Is enriched in lung tissue.

1923 by selectively.

Therefore has the potential to normalize the immune system, so moving to resolve inflammation and prevent progressive fibrosis.

Thereby stabilizing lung function and alleviating mobility and mortality.

Our lead program is focused on ILD, a group of rare immune mediated disorders that cause progressive fibrosis of the law.

Our initial ILD indication from them. So I think the most inflammatory form of Iot, which is characterized by the formation of Granulomas, we're comfortable immune cells in the lungs.

If left untreated it can lead to irreversible scarring and diminished lung function.

Current treatment options are limited and often include treating the inflammation.

With corticosteroids or other key leaders.

Therapies, which have limited efficacy and.

Long term toxicity.

Additionally, many patients do not respond to this day standard of care.

There remains a meaningful a novel treatment option for patients with progressive disease.

A better efficacy and side effect profile.

We recently spent some time deepening our understanding of the need for new treatment options for patients with <unk>.

Including alternatives to steroids.

And we've made a concerted effort to better revenue.

Unit.

As part of these efforts we are now.

Andrew Wilson sarcoidosis patients that advocate has been.

Advisor to the company.

And we have dedicated the past 20 years to promoting awareness and generating support to accelerate research to find a cure for this business.

He co founded the assets are the leading international non profit organization dedicated to finding a cure and improving care, let's look at other patients.

Previously served as president and a member of its board of directors.

From firsthand knowledge of accretion income.

Bind with our longstanding advocacy experience in relationship with net sarcoidosis community will help support <unk>.

<unk> strategies for advancing our 1922 clinical program.

So the doses and we look forward to other contributions in the future.

Additionally April with sarcoidosis awareness month.

And as part of our efforts to bring attention to this chronic debilitating disease.

Revenue for.

And a virtual town hall on steroids and sarcoidosis.

To discuss treatment options and strategies for patients living with store growth.

I was honored to join this panel, which included two sarcoidosis patients I think leading pulmonologists.

This channel.

Provided in real world and per Se in perspective, highlighting the toxic effects of steroids.

Putting a light on the need for better and more effective treatments.

The majority of sarcoidosis patients will receive steroids are some 40 million from.

Of course of treatment.

Corticosteroids are highly associated with obesity.

Good day.

Greece bone density cataracts.

CVR energy.

Moving each of these side effects on their own or a condition to treat and manage.

Early user experience agents, such as cytotoxic immunosuppressive have limited clinical evidence supporting our Houston circuit.

And are associated with significant side effects, such as infection liver toxicity and even malignancies.

We believe that patients deserve better.

I think <unk> presents a potential option to do better.

In clinical studies per day, 1923 has shown a favorable safety profile.

This includes data from our phase one study in healthy volunteers.

And in patients with COVID-19 related severe respiratory complication.

And two independent data safety monitoring Board review from the ongoing phase <unk> study in holidays.

And each of these studies 1923 was assessed to be generally safe and well tolerated with no drug related serious adverse events.

Based on recent proof of mechanism and its favorable safety profile, while $2 23, it could be a transformative alternative to steroids and other available treatments with improved patient outcomes.

As a reminder, our ongoing trial in pulmonary sarcoidosis is a phase <unk> randomized double blind placebo controlled multiple ascending dose clinical trial in 37 pulmonary sarcoidosis patients.

Score consists of three cohorts.

Doses of one three and five milligrams per kilogram of 1923.

People don't intravenously every month from six months.

The primary objective of this study is to evaluate the safety and tolerability of multiple ascending doses of $19 23.

Secondary objectives include the assessment of potential steroid sparing effect from 19 to 23.

In addition to other exploratory assessments of efficacy such as lung imaging lung function of transplant pulmonary function test and relative share in biomarkers.

Based on our trial design, an integral element of the study is to assess steroid burden in the 19 to 20 million treatment groups compared to placebo.

As we've discussed here vis per day due.

To the side effects and toxicity of currently available treatments.

Crucial need for alternative to existing treatment options, including stories.

We look forward as a result of this study we would expect moving forward.

Third quarter.

I'd like to now turn the call over to after moving annual reserves as.

As I mentioned, we recently promoted lovely to the company's executive leadership team to manage research and scientific operations.

Leslie has dedicated her career with <unk>.

Synthetase biology, and the pathway they regularly.

A study under non proportional inherits cofounder and having served in scientific research rolled out each other since joining the company in 2007.

We're very pleased.

With us today to review recent updates.

From our research pipeline, starting with our <unk> antibody program.

Thank you Sanjay I'm thrilled to continue my tenure at <unk> and expand the scope of my responsibilities related tomorrow. When he starts from scientific operations, particularly at a time when we are really starting to see some encouraging results from the work that we've been putting together over the past few years.

About two years ago, when initiated collaborations with experts and RPG biology from how it would be a more programs. It is extremely gratifying to see these collaborations carefully, particularly in regards to helping us better understand the underlying mechanism of our therapeutic antibody training and RV channel.

I'm very pleased to be here today to this call from the exciting research from <unk> in general both in house and.

Got it.

I'll begin with a bit of background about NFC chip, which is a compelling therapeutic target in non break in these areas, including oncology and inflammation and I'd be curious up regulated from a variety of solid tumors, such as breast lung and calling a bottom.

And it's particularly highly enriched in golf have changed.

In addition, as we reported earlier this year and I'll get you a highly at all from key immune cells indicated in regulating cancer progression, including tumor associated macrophages and myeloid derived suppressor cells among other high.

And I can share expression has been linked to worsened pain patient outcomes in several cases, which in some cases may include drug resistant to current therapy, such as chemotherapy or targeted agents channel accounts and overall survival.

Antibodies that can selectively block different assets and NLP two signaling pathways may have therapeutic potential.

In cancers, where NRT true.

It generated a panel of antibodies to selectively target domains of anarchy channel, including health interacting with him offline that day.

And certain king.

If you ultimately want.

And RPG and digesting home and the tumor microenvironment and it's an important progression of certain growth of Cantor.

Increasingly validated.

Hey, Ken a fully humanized monoclonal antibody developed and optimized internally by our antibody engineering team.

Typically and functionally blocks the interaction between MLP true and then Jeff based on compelling preclinical data in oncology model well human derived and animal we selected a candidate to advance two investigational new drug or IND, enabling activity.

Just last month, we presented two posters at this year's American Association for cancer Research enrollment.

Built upon our preclinical work related to 28 cash and strengthen our understanding of the blocking VEGF mediated anarchy testing on other potential approach to inhibiting tumor growth.

The research because they didnt need posters was conducted in collaboration with a leading cancer researcher Dr. Arthur material, one of our scientific advisers and his lab at the University of Massachusetts Medical School.

These posters represent significant progress we have made towards understanding part of the underlying mechanism by which blocking NRT to address signaling in tumor cells can inhibit tumor growth and metastasis.

And just any insight strength in the range between an RPG and a seminal process involved in tumor progression and the helium from kind of all transition or E. N G, which is the acquisition of median time or stem cell like features by epithelium cells in the tumor that confirm migratory and invasive properties to lease up.

He is of great importance in the tumor microenvironment regulating tumor growth.

Fashion, and metastatic cascade as well as being implicated in tumor invasion of the immune system.

The data we presented demonstrate the therapeutic potential I think have any empty through blocking anarchy choose digesting assets in various types of solid tumors.

And what we presented when we generated two types of tumors with high <unk> expression triple negative breast cancer or T. N D C and non small cell lung cancer and.

In T N D C patient derived organoid as well as tumor thing of off mall 28, 10, sensitize tumors to.

[noise] herself to widely used anti cancer therapeutics, including the chemotherapeutic agents with packing or the targeted budget therapy benefit income.

Increasingly anti tumor effects of each project.

Furthermore, channel 28, 10, well Sheldon down regulate genes associated with Emt and stimulus in particular down regulating the expression of the debt what are central regulator of these profit.

This data suggests that 28 10 ability to impact <unk>, maybe one mechanism by which it mediated anti tumor effects in.

In addition to T. N D. C. We have also generated data demonstrating efficacy in other solid tumor models, including non small cell lung cancer, both as a single agent and in combination with chemotherapy. The ability of this antibody to promote the differentiation of our go off 15 ourselves away from stem cell phenotype and render them more susceptible to.

And Vince just conventional cancer therapy has the potential to be a significant advancement because there he resistant which is associated with tumor recurrence and metastasis is a major challenge from patients with aggressive cancer.

We continue to investigate 28, kt and its ability to block the NRT to addressing home office, including its effect on sensitizing aggressive cancer chemotherapy.

Particular true inhibiting <unk> in cancers from soft property we.

We expect more findings from our research on this evolving Manhattan, including in model of patient derived <unk>.

Upcoming Keystone symposia on cancer stem cell scheduled for later this month.

We are very pleased with the preclinical data generated from 28, 10 day and plan to leverage the progress we've made and further understanding its mechanism of action of onto my cell phone calls as well as critical immune cells from tumor microenvironment to build a compelling data package between pharma clinical strategy for 2018, and treating as I said fall into.

We really look forward to continuing IMD, enabling activities for 28 10 to support advancement into clinical trials in the future.

As we continue with our A&D, enabling activities for 20 8-K, we are committed to progressing this program to clinical stage development last month, we announced that we've entered into an agreement with long day for the manufacturer of 2018.

We are very pleased to be working with a partner with extensive proven capabilities in antibody manufacturing to other production on our first anti <unk> two antibody.

Are you manufacturing commitment at this stage of development for 28, 10 is especially important due to the recent trends in our supply chain and increased demand for Biopharma manufacturing, which is in part a result from the uptick in activity due to the COVID-19 pandemic, we feel that investing in securing these capabilities now will help us to best service program.

Going forward.

In addition to our in house antibody engineering platform that is developing antibodies to selectively target to think domains of anarchy true our Hong Kong subsidiary Pangu is working on a bi specific approach based on NAV to choose role in regulating and inventory processes and interaction with various co receptors, we believe that financing.

Like antibodies present, a unique approach to create highly specific I get it in the system, which may be therapeutically relevant in certain disease states.

Bob you are paying you together with the Hong Kong University of Science, and technology or H K U S. T was awarded a grant of approximately 750000 U S dollars from the Hong Kong Government innovation and Technology Commission to build a high throughput platform for the development of Bispecific antibodies targeting it P. J.

We are pleased to have announced this week that pangu and H K S. T hub achieved the milestone set forth a nickel a share of the project.

And are all part of this project and with the development and implementation of a novel single cell antibody discovery approach, which has so far given numerous candidate candidate high affinity and I'll be true Paul receptor antibodies targeting debt, Jeff our three influx in day one.

Currently being screened and function.

Bispecific antibody approaches are increasingly being considered as a novel and differentiated approach to relevant targets and present, a unique opportunity for us to make spot. We are very excited about the progress so far and look forward to the outcome in the second year other project.

With that I will turn it over to our Chief Financial Officer, Jill Broadfoot to review our financial results.

Thank you Leslie.

Total revenues were zero and $8 1 million for the three months ended March 31st 2021, and 2020, respectively.

<unk> for the three months ended March 31st two.

2020 consisted primarily primarily of license and collaboration agreement revenues under the license agreement with Karen.

Research and development expenses were $4 5 million and $3 6 million for the three months ended March 31, 2021, and 2020, respectively. The increase was due primarily to manufacturing costs related to 1923 increased research and development expenses related to 28 pen.

And increased expenses related to the research program become Pangu H K U S T and the <unk>.

Longhorn government Gen.

General and administrative expenses were consistent between periods at $2 7 million and $2 6 million for the three months ended March 31, 2021, and 2020, respectively.

During the first quarter 2021, the company raised gross proceeds of $9 9 million through its aftermarket offering program with H C. H C Wainwright and company LLC and $15 3 million through its common stock purchase agreement with Aspire capital Fund LLC.

As of March 31st 2021, we had 56 million in cash cash equivalents and investments.

We expect our expenses to continue to increase in 2020, one as research and development of 1923 and 28 10 progress. This includes additional manufacturing cost for both 1923, and 28 10 to prepare for future clinical trials.

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

Thanks, Joe.

Our accomplishments this year to day.

Hard work dedication and.

Our whole approach so we are investing.

Clinical preclinical and discovery programs.

The readout for phase II proof of concept study.

<unk> 23 in pulmonary sarcoidosis.

As a key inflection points per year.

Really solid foundation for any invested heavily in a robust portfolio of translation from 1923.

Which we believe presents a strong.

Thank you and in front of Piedmont.

We are implementing the sales forces and building block approach for 2000 and income.

We generated preclinical data and if all of our other city.

Action through forward flows.

Sure.

We have sufficient capital to take us through the readout and always overdoses and launching a control for 28 kind of cancer.

To support that.

Generally our view for the company as we progress throughout the year.

We appreciate your interest and continued support.

I look forward to providing updates from the future at this time Joe Ludwig.

I'd be happy to take your questions.

Ladies and gentlemen, if you would like to ask a question. Please press Star then the number one on your telephone keypad again that is star one to withdraw your question breast are bound or hashed E. Lisa.

By while we compile the Q&A roster.

Your first question comes from the line of hard Taj Singh from Oppenheimer. Your line is open.

Thank you hi, everyone. Good luck nurse, Jackie Yeah ballpark harsh thanks for taking our questions.

First just on.

I remember last year, you announced the trial got fully recruited.

I think that criteria showed a steady 36 patients.

But those price already show 30 certification.

So maybe first just wondering is that from patient drop that youre enrolling additional patients and then second obviously, it's 37, it's now that even even number one.

Why.

Net additional patients.

Even though your treatment or placebo group on the waste cohort that person.

And so are you going to announce the last patient last visit thank you.

Sure. Thanks, Jackie so.

We have previously announced net target enrollment.

At that time.

Imagine several patients are in the queue.

One additional patient at that time.

Final cash.

<unk> has 37, I think ethically would be difficult to turn away a patient thats already.

<unk> been deemed eligible and those pass through screening so that occurred.

Right at that time, when we were.

Announcing that we met target enrollment so the final enrollment is 37.

Question is really around which cohort they have not been assigned.

Afterwards into our 150 milligram cohort in the five milligram cohort.

So the.

The most important point here is.

It's not a backfill it's simply a patient debt.

Hum.

As I said pad move through screening.

Pretty much the same volume sales.

Patients.

And therefore.

You really wanted to do the right thing and allow that patient who joins the over enrollment.

It's not a big issue not anything really tactical but.

More around clinical operations ethics.

With regard to last patient last visit and that's something we'll consider I think the main thing is we're on target to have.

Full readouts here in the third quarter.

And that's really what we're focused on.

Getting up 37 per patient.

Basically finish up.

Dosing and follow up visits and.

I think we're very much on track to have a Q3 readout.

Yep got it thank you for that.

Uh huh.

Great event, we sarcoma foundation last month, either picking the side effects of steroids.

And if you could talk a little bit more on the side because you know those non steroidal anti inflammatory drugs, both short term or long term and then thinking about your upcoming per quarter right out.

What types of data weighted.

Expecting there.

The reduction of time to achieve that.

All the different dose cohort.

If you could help us frame that top line release really sounds great.

Yes, great questions about some of the toxic effects you heard quite a bit about what steroids can do and.

From from the patients highlighted once a day patient in particular on that call really talked a lot about weight gain and some of the other.

Mood and irritability ensemble affects so many other things that we see from steroids, we know quite toxic to these patients and those patients that have moved on to either the more heavy hitting in minutes per person, that's really where you get even even scarier complications such as a higher.

Degree of infection risks.

Malignancy.

Also of concern once you actually move to those agents many of those agents who are actually.

Recently approved for chemotherapy, so you're really talking about.

The toxic burden of some of those more.

Outside of toxic immunosuppression.

The purpose of these patients have to advance so there's.

There is a tremendous amount of interest.

And it's growing and it's accelerating to have a therapy like ours, which I mentioned.

I think it's something that could be leather transformative.

Changing the paradigm and how we treat sarcoidosis.

One other ways and probably the most importantly, we're going to be looking at it from an activity standpoint is to focus on steroid burden by the experts have said this is a key way that they will.

Learn around the loan.

And feel good about the activity of $19 43.

We will be looking at a number of things here and highlighting these things either in the upcoming months around what to expect.

With regards to.

Percentage reduction, we'd like to see absolute reduction, we'd like to see cumulative burden over six months, how much better we can.

So these are all the things that we're focused on.

Just actually.

Or potentially another event relative to.

To really set the table here around expectation.

From what I can understand from the experts.

They're looking for that signal a steroid reduction in this trial.

And I think that's really.

Increased the true.

A tremendous amount of clinical confidence as we move into phase III, if we were able to observe that in our current trial.

That's very helpful. And then the last question I'm, sorry price release earlier this morning.

By specific calling from our subsidiary in Hong Kong.

Talk about other rationale.

Got your European tour involved a bispecific format at what kind of advantages you kind of all day.

You know versus I guess $40 from combination therapy, even more specific more specific format.

Yeah, I'll comment that Eylea, even ask lovely to chime in as well, but our strategy is really as we understand the biology, we like most of our in house work, which is of course working on targeting specific epitopes to miracle in two and tuning the biology, just looking at Neurocrine.

The literature has also informed us that they are appealing.

Is it really interesting receptor embedded from the quarterback other interactions with other receptors such as truck sales and headwinds other other VEGF receptors that debt Leslie pointed out so how do we leverage and learn more about assets.

Essentially they create new pipeline.

This is why the Pangu collaboration.

Moving to basically bring in non dilutive capital from the Hong Kong government.

On this bi specific approach is really exciting and I think it offers us another opportunity.

To create a new pipeline of discovery candidates by really understanding and mining that side of the biology literally do you want to add anything about.

Some of the simple.

Opportunities that some of those other.

For South Korea.

Engagement from European too sure Sanjay I mean, I think one important aspect of this as well is that it provided us the opportunity to expand our our antibody engineering into the Bispecific realm and to bring on from really cutting edge technology and advanced some of those things forward with some non dilutive funding and the grant under the Scrappage scheme.

Because it's really about setting up a platform but.

I mean, it's absolutely right that if you're thinking about anarchy, two other receptor and the stuff that is actually coming together with these other types of co receptors. There are novel ways to actually sort of tune those reactions and create agonist. So most of the time you know with our mono antibody monoclonal antibodies, we're gonna be blocking them all going to work.

Net natural ligand other not be true in this case, we can actually bring the receptors together co receptor and anarchy true itself to drive some of that signaling and so there's a certain disease States. For example, you may want to send a form the medic that would actually drive.

So net net capacity so let's just come at it from the other side of the claim as well.

Yes, I'll just add one I'll just add one other thing about the specifics.

A few specifics on the market, but we've seen already that market that close to potentially $20 billion.

Total universe, when you think about.

Bi specifics so it really.

Smart strategy for us to tell.

Look into this platform approach a bi specific approach and the fact that we can do this by accessing.

These grants with the Hong Kong government I think is a smart way for us to tap into what could be.

So really a.

A large <unk>.

Commercial opportunity in the future.

Okay.

Great. Thanks, a lot other cutter and really appreciate all the questions. Thank you.

Your next question comes from the line of Manuela Bran Chatty from.

<unk> H C. Wainwright your line is open.

Good afternoon, guys and thank you for taking my question.

A couple from me yet so we are waiting for the other things that we did hire 23 and the potential pivotal trial and are you guys planning to do any formulation work towards Florida, the possibility of a different formulation, Florida, Hey, Kai at 1923 other than <unk>.

Okay.

Hi, Emmanuel so that's a that's a great question I think as a small company before that.

Tablets proof of concept with our IV administration, but I think from a patient perspective.

Certainly.

And once once a month therapy is great. But then very quickly from a lifecycle point of view. These patients will want to say, perhaps could that could be administered.

Even easier than that when you look at.

When you look at sub Q administration.

Some other companies.

Hansen in their lifecycle planning.

They consider things like that I think from a formulation temporary your question makes a lot of sales strategy, but I would say.

Perfect.

We can establish proof of concept here then absolutely we can look at moving formulations.

Okay.

Moving more attractive to patients.

Perhaps a sub Q administration that can be administered.

As we say three to six months, that's what you see with some other therapies.

As we advance in lifecycle.

Sure. Thank you for that and with regards to the high throughput platform being developed by Tango.

Should we expect multiple ind's coming forward from this program and can you give us a sense of your expectation in terms of timelines.

So how should we think about the potential clinical development of these assets would destock in China, and then move to the U S or as you I know he currently but as you.

Can you share your thoughts from me.

Yes.

It is early.

I'd like to hear your thinking of.

We definitely think that this is an area we tend to really start to understand the biology, and then start to advance.

Our discovery thinking, but the goal here really is.

Okay.

You described we'd like to be able to identify every opportunity that leads to a <unk> candidate.

From this platform I think there is an ability to do that.

Does it take to put a timeline on it just just right at this moment because we have just gotten through the first step of this milestone.

But I do think that as we look to provide updates to you in the future. That's the kind of things to pay attention to do we have a discovery candidates in the works at bi specific antibody with regard to development I think it's a little bit too early to say with regards to how we would interface with China.

COVID-19, a little bit of a different situation, although it is becoming much more.

You have to think about it a little bit more as the connection to mainland.

A little stronger here.

But I think thats net.

A strategy that.

We'll be working on that will be getting back to you.

We would like to actually emerge with a new discovery pipeline candidate from that.

Platform.

Sure. Thank you and again I know data maybe forward looking.

A question.

When looking at the results reported at the ACR meeting in Triple negative breast cancer models.

<unk> 28, and it seems to inhibit tumor growth when used in conjunction with cisplatin and they've achieved from up so you talk more of it before about the mechanism of action behind behind you. The facts about how do you think of that.

The drug would be better positioned for the treatment of triple negative breast cancer should you decide to move forward with the clinical development in this population.

Sure and again I'll have Leslie chime in here, but clearly a very aggressive form of cancer, where we still have a lot of room to improve efficacy.

We remain.

Amazing strides in the last couple of years Treaty.

NBC, but theres quite a bit of resistance, but also sort of evolves.

And I think what we're learning from them.

Utility decidedly telenet tumor inhibition in growth, but you're also seeing quite a bit.

<unk> data that can help patients who might become resistant.

Net.

We have a mechanistic understanding of how that might be occurring.

Leslie can also add from a her thoughts more specifically about that data.

Yeah, absolutely. So you know we are looking at a number of different types of other aggressive solid tumors and we have made the most of them now.

We generated the most men didn't specifically in triple negative breast cancer because of our strong connection with your math and a doctor I am Curios lab, where they have a strong focus so that is where we're getting a lot of early data coming out that you're seeing and I think you know.

Sanjay captured it very well and this is a very aggressive type of tumor that has very high enough into your expression and has a lot of issues with resistance in patients resistant to current therapy and so we're seeing especially interesting to me is the channel organize that we see from either directly patient derived tumor organize where we're seeing a response.

Sensitizing needs from a organized to chemotherapy or bevacizumab type treatment conventional therapies and we're understanding the mechanism in the Organoid <unk> 19, changing that are indicating that processes surrounding <unk> or this <unk>.

Development of a stem cell like phenotype are being reversed and the presence of 28 10, and so we're starting to piece together that mechanism and figure out debt that.

That will be that is a potential population could be.

That could really be helped with with something that could do.

That seems to Jive.

Got it got it thank you very much.

Your next question comes from the line of Zigbee Chawla from Roth Capital Partners. Your line is open.

Hi, guys. Thanks for taking my questions and congrats wisely are really exciting for you just have a couple of questions. I think just follow up from some other questions that have been asked I think the first one for me is that in terms of your relationship with Tango just wanted to make sure that you're retaining full rights to the buyer.

Specific popcorn or is that you know some kind of agreement that you have in place.

Yes, certainly.

That's a great question and yes, we are retaining full rights for.

The work that we do there so I think.

That's a key component of <unk>.

Retaining the value of what we think is a really outstanding opportunity for us to explore.

Yes.

Thank you and then the next one again another follow up from 1923, I know, we're still waiting for that the data, but like someone else alluded to the call that you participated on was really good in terms of what we articulated them you know the concerns about using steroids in patients with pulmonary sarcoidosis in zone.

Just wondering you know that's kind of how this kind of study is set up in terms of you know figure.

Figure out if patients who use unless there was I was just wondering if that's probably going to be the same setup for your phase three potentially pivotal study.

I think we are we are poised.

Poised well too.

Basically interrogate an endpoint that is accelerating.

And it is the law.

Liberty is something that May give.

Good day really need to look at closely I think you've heard the efforts are that they are spending quite a bit of time here.

Educating them with Larry over there.

Although volume.

Importantly.

Neutral net hopefully endpoint patients want to get off steroids, we always thought.

Debt.

At the doses, we were looking at 10 milligrams at higher than it was certainly the case, but I think what you heard on the call is from patient. So we don't want to go on steroids at all.

So very quickly I think our therapy.

It would be looked at from the first line therapy.

That we can even.

The performance to explain it.

So there is more and more momentum, we just have a methanol transit from salary.

Based on our proof of mechanism in particular, I think our therapy.

As I said could be transformative in here as a first line.

The option for psychosis patients.

Especially given the fact that we thus far penetrated really a great safety profile.

And I think we're poised well.

In the sense of this endpoint is becoming more and more spotlighted by via <unk>.

Thanks, Sanjay and then the last follow up here is just on you know your efforts with you in our PQ antibody got excited what the ACR data then the partnership with with La and I was just wondering what else is left to be done for the IMD and then lastly, Eddie.

Comment on semi of discovery efforts I would say, it's all bearing I think I won't point you guys mentioned, you know focusing on NK cell biology, I was just wondering if you had any update from that because that sounded really exciting.

Yes.

With regard to what.

What are the next steps for the <unk> program as I said, we'd like to get it to we expect to begin a clinical trial next year from cancer. So as we're continuing to look at different.

In vivo models tumor models, we Nomura per limited.

Okay.

Is implicated in a number of different tumor settings.

So we'll continue to look at a few other models and that will then allow us to basically focusing on where we have our best effects from where we think.

Our best indication should be for our first cancer trial.

That is what you can expect.

CSD active.

For the remainder of the year with a follow on data, which then should focus everyones attention to okay. This is where <unk>.

Has the best utility and he is the best opportunity to really help patients.

It will be finishing some of that translational work to other course of this year, we will complete some of that constant <unk> work that is required before we actually move into the clinic and this is another reason why it was important for us to highlight the laundry collaboration because we're working with.

The pre eminent as you will see them all out there very important for us to actually get that relationship locked up so we can actually have really.

Premium clinical material revenue ready to go into the clinic also imported right now I think a lot about the company debt under estimating the supply chain demand with manufacturers.

So for us to get ahead of that it was something we hear a lot about the company talk about because I think they are struggling with their ability to actually engage in it.

Plan ahead.

With only one loan.

So this is not growth slows down and we are really thrilled to have a top tier partner.

<unk> with regard to some of the funding we put out earlier this year with NK cells and we have.

Still a lot of interest there to mature some of those findings and get a receptor candidates.

Would it be transparent about that put that out in.

Some form of publication or abstract so that's tracking well I think the important thing. There is we're now in the process of validating those receptor targets on the NK cells, we'd like to be very very thoughtful and make sure that we.

[laughter] peripheral with PS dot all the is there, but I think big sales from that program as well to be able to timeline.

It's going to be our next receptor target.

Much like we did when they reported to a few years ago I think thats in the cards there for them for that program.

Perfect. Thanks, again and congrats on the progress.

As a reminder, ladies and gentlemen, if you would like to ask a question. Please press Star then the number one on your telephone keypad.

Again that is as far one.

Your next question comes from the line of Yale Jen from Laidlaw. Your line is open.

Good afternoon, and thanks for taking the question.

Just want to.

First question is about the 19 twenties, three just a little bit forward.

Looking questions, which is debt.

If the readout.

Third quarter is robust I assume you guys going to advance into a potential pivotal study.

My question is debt.

Yes.

Era.

Every type of endpoint.

Could be accepted by the FDA.

Primary endpoint or you would need to conduct more functional type of endpoint plus a way to potentially to get gain approval.

Yes, thanks for the question.

Certainly our plans and this will involve interaction with the FDA.

So from owners.

Aggressively into a true.

Pivotal trial I think when you talk about the rare disease like circuit doses patients still have a lot of time away and we can be on any.

Our lifecycle of 10 years of running trials here many of these folks need therapy today Secondly, we know.

We're learning more and more.

These patients desperately get off steroids and the ones that are newly diagnosed and don't want to be put on steroids, but going to your second question.

If there was ever a time for.

For the regulators to really look seriously at steroids Barry.

Surrogate endpoint as a primary endpoint.

I can tell you that in the years I've been involved in this program.

There is significant momentum moving in that direction and this is the reason why engaging more with the patient community.

<unk> done this internally, bringing and Andrea as a patient adviser and then also the <unk> focus on highlighting the toxicity of steroids.

I think it sets up really well for us to have a real discussion with the regulators and say this actually should now be thought of more as a primary endpoint. So a bit predictive right now what the outcomes of those discussions will be wood worldwide regulators, but I would say that right now.

The momentum is really building floor for a steroid reduction employees to be at a minimal part of a composite primary endpoint.

I think it sets up sets up really well for us.

Focusing on.

Cash flow.

Okay, Great that's very helpful and.

Another question.

For 2008, which is involved in the process called the Emt, you mentioned and that seems to be a space very few competitors at least we cannot find any.

Do you have any comment in terms of.

Did you guys buy other competing program also in this space or are you potentially could be the first in class therapy if.

Successful.

Well, yes.

We are we're cutting edge science company, we become less so as we came out of pulp lab, Paul has been a tremendously successful scientific entrepreneur.

Talk to you about founding of myeloma, Cubist and Rutledge and places like that so we're not afraid to be bolt around.

Some of the size of R&M expense and we can see it mechanistically. So our findings from <unk>, yes.

We're really excited about that.

We think and.

Some authors have even said that this could potentially be a backbone type of therapy. If we are re modulating some of those measured condo sales.

As Roger pointed out that stemmed us there.

We significantly can can make leaps here in cancer, and maybe even attack resistance.

I do think that it's an area that.

Thank you.

Very much untapped.

Iology mechanistic.

Mechanistic understanding is pointing us in that direction, so we're going to follow it.

And.

I think again, we get the lead here potentially an area where even at ACR. Please in this last meeting and the meeting before that you see more and more interest.

E&P biology.

So perhaps it about five years this will be an area, where we compete some other companies what we've learned about it.

So stay tuned for that I really think that that's an interesting area that locally certainly is going to be working hard on.

Okay, Great and then maybe the last question here is Paul your off price.

Approach.

I understood.

And two is not necessarily in Iowa.

College therapy.

But given debt.

Yes.

Generally working.

Across environments.

In terms of the Bispecific.

Would it be.

We consider one of them.

By targets will be could be in any kind of a check.

Check client related or other type off the immuno oncology related targets.

What does that make any sense.

Oh.

What's the duration.

Thanks.

No that makes sense to me for sure.

Hum.

I'm going to have monthly say something as well here, but the co location revenue.

Loan growth.

Two does here as you see other than <unk>.

Factors I'd like to aggregate and co locate next to Neurocrine too so it's very much.

Quarterback that we can.

If we created by specific essentially to agonize.

Great.

Cowen and certain other receptor you're absolutely right. This could be another asset that we could turbocharge.

The immune response, if you will.

And attack cancer cells, but we have to we have to understand that mechanistically improve it so.

So I think this is really part of our scientific rationale and it's why we were able we were awarded the grant because I think the literature and the science pointed every day in that direction now we're working to basically build a candidate debt.

We play exactly do what you say here.

Ludwig do you want to add anything per deal.

Absolutely. So I think we alluded to it a little bit as we walk through the call today around this expression that we see for anarchy true on these T cells that are located in general microenvironment. So.

I don't want to get yourself itself, but also tumor associated macrophages and myeloid drive suppressor cells to name a couple of them. So we presented a poster earlier this year out of kind of Keystone level to work through that work.

Well definitely.

Good of heavy investigation to understand the role for now it's on to on those sales and how that might be.

You're playing with the activity and what's happening with these more music channel.

The Helios side of the channel So I think it's.

They tune, where we're heavily at work on that and really investigating it and.

So I think the mechanism itself will bear out whether or not it makes sense to go at that with a bi specific approach or whether there.

Really a monoclonal strategy that can work as well so we're as Sanjay said, we try to be cutting edge and on.

We'll be open to new science, and let the mechanism and the data drive us why we should go.

So I think we're very open to the best way to drive with these targets.

Thank you.

Okay, great. Thanks, a lot and congrats on the progress so far.

Sure.

Yeah.

And there are no further questions over the phone line at this time how non.

I'd like to turn back the call over to Sanjay Shah from Sir.

Thank you great questions today.

Increase in not only our clinical program, but the advances were making in your colon biology.

Specific platform and Pangu income made you picked up on how that could be a really intriguing new area. It opens up.

A lot of potential for our pipeline.

Really appreciate the questions the interest from everyone today.

Looking forward to speaking to you.

Thanks, everyone be well.

Ladies and gentlemen. This concludes today's conference call. We thank you all for participating you may now disconnect have a great day.

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