Q2 2020 aTyr Pharma Inc Earnings Call
[music].
Good afternoon, ladies and gentlemen.
I'll come to the top almost second quarter 2020 conference call.
At this time all participants on in listen only mode.
Later, we will conduct a question and answer session.
You asked a question going to section you will need to press Star then one on your telephone.
As a reminder to our conference call. This conference is being recorded for replay purposes.
It is now my pleasure to hand, the conference over to Geo profit ATAC Chief Financial Officer, It's brought foot you may begin.
Thank you operator, and good afternoon, everyone. Thank you for joining us today to discuss he tires second quarter operating results and corporate update we're joined today by Dr. Sanjay shoe class, our president and CEO on the call Sanjay will provide an update on our corporate strategies include.
In the clinical development of 80, why our 1923 and our research programs in nerve pelon too or NRP to MTR in east of the taste biology.
Well then review the financial results.
And our current financial positioning before handing it back to Sanjay to open the call up for any questions.
Before we begin I'd like to remind everyone that except for statements of historical fact, the statements made by management and responses to questions on this conference call or forward looking statements under Safe Harbor.
Her vision that that 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.
We see the forward looking statements disclaimer in the company's press release issued this afternoon Hezbollah's the risk factors and the company's FCC filings and included in our most recent annual report on form 10-K, and quarterly reports on form 10-Q.
Undue reliance should not be placed on forward looking statements.
Speak only as of the date, there made as facts and circumstances underlying these forward looking statements may change, except as required by law you tire pharma disclaims any obligation to update these forward looking statements to reflect future information events or circumstances, I will now turn the call overcome Sanjay.
Thank you Jill good afternoon, everyone and thank you for joining us for our second quarter 2020 results conference call.
As we begin with our second quarter update I would like to take a moment to acknowledge that has we're now in the second half the year.
We have adapted rather quickly to operate.
The new norm.
To the Coke and 19 global endemic.
I'm extremely proud to be HR team or partners.
Oh, and all the physicians and patients who continue to rate remained responsibly dedicated to our research and development activities even.
Even in light of the urgent media medical care attention and resources required in response to the pandemic.
I'm, particularly inspired by our research team and collaborators who continue to generate.
Important pre clinical and translational findings, resulting in published data.
Despite the current challenges and considerations of working on site in the low.
And our clinical team.
It's really worked tirelessly to initiate a new trial and called the 19.
Entirely remotely and early virtually is a testament to the community that we're trying to build here and continue to expand upon even in these trying times.
Now, let's get started with our quarterly review and corporate update.
During the second quarter of 2020 in subsequent periods HR continued to progress to development.
Our lead program P T Y on 1923.
I'm pleased to report that the majority of sites for our trial in pulmonary sarcoidosis have resumed clinical trial activities.
As previously mentioned, we initiated the Neutrolin colder 19 patients with severe respiratory complications in June.
Additionally, we have continued to drive value and build momentum with our pipeline.
We generated valuable preclinical data from our NRP two antibody program in oncology.
That validates the high quality in specificity those antibodies and their potential to be developed for therapeutic applications.
Based on these findings, we expect to declare an investigational new drug or R&D candidate later this year.
We also anticipate the completion of the first phase of our tier nascent stage research collaboration, but CSL behring early in the fourth quarter.
So as we begin I'll summarize the key highlights from the second quarter in subsequent periods.
First off we progressed, our phase one be to a clinical trial of 1923 in patients with pulmonary sarcoidosis.
As I mentioned the majority of sites that have to pause enrollment due to the pandemic have now presume clinical trial activities.
That's clinical trial conduct is dependent on cold in 19 activity.
We continue to work with each site regarding their institutional policies and procedures in order to ensure the completion of the trial.
We initiated a phase two trial 1923, including 19 patients with severe respiratory complications.
Enrollment is currently ongoing.
And a preplanned blinded independent data seek to review of the first flight patients resulted in.
A recommendation that the trial continue on modified.
We expect to report data from this study in the fourth quarter atmosphere.
Sure and pharmaceutical our partner for the development and comers commercialization of 1923, four interstitial lung diseases, where I oldies in Japan initiated a phase one study to evaluate the safety.
Pharmacokinetics Immunogenicity of 1923 in Japanese healthy volunteer subjects.
We published two abstracts and the American Journal breast store in critical care medicine.
Characterizing the binding properties of 1923 to NRP too.
And the expression of NRP two in Sarcodes anymore.
These findings were also presented its posters at the American Thoracic Society International Conference Virtual meeting.
We presented preclinical data at the American Association for cancer Research virtual annual meeting.
From our NRP two antibody program, demonstrating tumor inhibitory effects in preclinical models of triple negative breast cancer.
And finally, we continued our TRT sympathies research collaboration an option agreement would CSL behring.
Extending work on the first phase of the research program through September Thirtyth 2020.
We have accomplished a great deal of thus far in 2020, despite the challenges presented by the Cold 19 pandemic.
And we continue to make significant progress in the third quarter.
Today I'll provide an update on their clinical program with our lead therapeutic candidate 1923.
Including the status of our phase one be to a trial in pulmonary sarcoidosis.
Our phase two trial and cobot 19 patients.
And our phase one program with our partner in Japan.
I'll also comment on our ongoing preclinical research and development efforts for programs and NRP, two and tier in a synthetic biology.
So Joe will come to conclude with a review of our financial position.
Let's begin with some background on our program for 1923.
I think 23, the potential first in class Immunomodulator.
That down regulates immune responses in inflammatory disease states.
Inflammatory triggers whether they are organic inorganic infectious or auto immune in nature can lead to address immune response and some patients.
Resulting in pathology.
923 target receptor NRP too.
Upregulated on immune cells in the loans during this process.
Hi, assistant unresolved inflammation in the long can lead to fibrosis or scar.
Which can result in increased morbidity.
Including impaired lung function and irreversible organ damage.
And mortality.
I think 23 buying selectively to neural into down regulate aberrant immune responses.
The goal of resolving inflammation in preventing progressive fibrosis.
Thereby stabilizing lung function and alleviating morbidity and mortality.
Our primary development focus for 1923, so dressed as substantial unmet medical need denial D.
The group of chronic immune mediated lung disorders that can result in progressive fibrosis and alone.
Which are lead clinical indication pulmonary sarcoidosis is a major for.
As David emerge on the underlying disease mechanisms, causing severe respiratory complications and covert 19 patients.
It became apparent.
There was significant overlap with I'll detail technology.
Leading to our decision to investigate 1923 as a possible treatment for these patients.
We also believe our findings the 1923 and colgan 18 patients with severe respiratory complications.
They provide insight into 1923 potential to treat other acute inflammatory loan disorders.
In addition to our clinical efforts, we continue to strengthen our mechanistic understanding of 1920 degrees immunomodulatory properties through NRP to signally supporting its potential use and inflammatory lung disease.
Last week, we presented two posters at the American Thoracic Society International Conference Virtual meeting.
Abstracts are these posters were published earlier in the American Journal rest story in critical care Medicine.
Findings highlight the potentially significant role of NRP two in serious inflammatory lung diseases.
And further elucidate the mechanism of action of 1923.
These findings report the NRP two is expressed and readily detectable within the Granuflo most of long and skin samples Ogs sarcoidosis patients.
Through this research we demonstrated that NRP to expression can be detected on key immune cells that are known to play an important role in inflammation in granite global formation.
Additional research published demonstrates a 1923, specifically and selectively binds to NRP too on the cell surface.
These findings characterise the molecular bases for 1920, threes immunomodulatory properties and indicate that NRP two could be a novel therapeutic target for immune mediated lung diseases.
Now, let's take a moment to discuss our clinical program for 1923.
We'll begin with an update on our phase one be to a trial.
I'd like to 23 in patients with pulmonary sarcoidosis.
As a reminder, this randomized double blind placebo controlled multiple ascending dose clinical trial in 36 pulmonary sarcoidosis patients and consists of three cohorts.
We previously reported successful results from an interim safety analysis of 15 pulmonary sarcoidosis patients with received a minimum of one dose of blinded study.
In addition, during the first quarter our independent.
It in safety monitoring board completed its second safety review, allowing us to move from our three milligram per kilogram dose.
And test or five milligram per kilogram dose in cohort three of the study.
The final group of patients in this study.
Based on these findings we progressed to recruiting the third and final collaborative studies.
Due to the Kogan 19, pandemic, we announced an impact.
Two enrollment and that some but not all of our investigate upsell investigational sites had to pause enrollment.
Last quarter, we announced that some of those sites were expected to reopen enrollment in late May early June.
I'm happy to report that we did see that occurred in early June.
And now in fact, we presume clinical trial activities that the majority of our sites silver pause.
Where it has been safe for providers and patients to do so.
We plan to provide an update on the expected timing of results. Once the trial has fully completed enrollment.
In order to progress our global development strategy for 1923.
Earlier this year, we entered into a collaboration and license agreement with churn pharmaceuticals for the development and commercialization of making 23 for all these in Japan.
Earlier this week, we announced secured.
Has been cleared by the Japanese regulatory agency Pharmaceuticals, and medical devices agency.
Or P.M.D.A. to begin clinical development work for 1923 in Japan.
With approval of a clinical trial notification were CTM.
The CPN permits the startup phase one trial, which will be conducted by Q1, and we'll evaluate the safety pharmacokinetics and Immunogenicity of 1923 in healthy volunteers in Japan.
Establishing safety of a new therapeutic drug candidate in the Japanese population even.
Even when prior safety data is available is often a requirement by the P.M.D.A.
This is an important first step to advanced clinical development of 1923 in Japan.
For development purposes, 1923 will be referred to as PRP dash or 120 in Japan.
As a reminder, under the terms of the agreement ITAR previously received an $8 million upfront payment and is eligible to receive.
The 167 million in the aggregate upon the achievement of certain development.
I'd love to worry and sales milestones as well as tiered royalties on the net sales in Japan.
A cure and has exclusive rights to commercialize 1923 in Japan. So we're all loyalties.
Okay.
Now, let's turn to our phase two trial of making 23 and Kogan 19 patients.
As we already mentioned.
For him to be lung injury.
Maybe caused by an infectious agent.
While our initial focus has been on chronic lung disease.
We believe the mechanism of action of 1923 may have potential in acute inflammation.
We learned early in this crisis that the in friends, we lung injury related to call. The 19 sure some remarkable similarities to those observed and I'll detail.
Many coking 19 patients with severe disease experienced serious sometimes fatal respiratory complications caused by an excessive inflammatory response in the long.
Primarily driven by T cells.
1923 has been shown preclinically to down regulate T cell responses.
Thereby dampening the inflammatory cytokines and Chemokines signaling.
Both of which had been implicated in these very severe over 19 cases.
In addition to these anti inflammatory properties.
23.
Has also been shown improve lung function in animal models of immune mediated acute lung injury.
By targeting average immune responses, we believe that 1920 threes mechanism of action has substantial overlap with this disease pathology and presents a very compelling opportunity to potentially treat the subset of covert 19 patients.
As the pandemic has ensued weve continued to learn more about the source code veeva koby to virus and the disease pathology and progression of clock over 19.
Most notably the recent article published in the New England Journal Medicine.
Did that lung tissue analyze from patients who died from cobot 19, respiratory failure showed an increase in the expression of and our P. One in NRP too.
Suggesting these genes are up regulated in response to Sars koby to infection.
Additionally, two independent labs reported the discovery that Sars koby too.
Spike protein one directly binds to the B one domain of Neurokinin, one receptors on the cell surface, including NRP, one NRP too.
They also showed that preventing this binding interaction results in decrease sell infection.
Further data is emerging that patients who experienced severe respiratory complications from cobot 19 may experience longer hospitalization stays.
Permanent injury to long.
Potentially including pulmonary fibrosis.
We believe that by administering 1923 earlier in the progression of coking 19.
It may be able to preserve lung function by normalizing immune system response.
Based on the strong scientific rationale.
Worked very closely with the FDA to initiate a phase two randomized double blind placebo controlled study and 30 hospitalized covert 19 positive patients.
If you're respiratory complications.
Do not require mechanical ventilation.
Patients enrolled in the trial are assigned to one of three cohorts of 10 patients each.
Patients will receive a single intravenous dose of either one or three milligrams per kilogram of 1923.
Or placebo to be administered in the hospital.
Patients will be followed for 60 days post treatment and we plan to enroll at up to 10 centers in the U.S.
While the primary endpoint of the study is to assess the safety and Tolerability.
I'll be single dose of 1923, Indus acute setting we're also focusing on a number of key clinical outcome measures, including.
But not limited to fever, hypoxia and inflammatory biomarkers.
As for our protocol and independent data safety monitoring board or do you have some be conducted a preplan blinded interim safety analysis. After the initial five patients were dosed in this study.
Study drug 1923, or placebo was observed to be generally safe and well tolerated no drug related serious adverse effects.
Based on these findings, which are consistent with previous safety assessments of 1923, the SMB recommended trial to continue on modified.
[laughter], you're very encouraged by our progress to date.
With this type of 19 trial.
Given the challenges of conducting clinical trials amidst the current hemodynamic.
Enrollment is currently ongoing and we expect to report data.
From this important study in the fourth quarter.
My dogs are excited to about incest study as well now, let's turn to our research and discovery pipeline, including our NRP two antibody program.
Which we believe has great potential decreed pipeline value and tried meaningful milestones in the areas of oncology and inflammatory disorders.
We recently presented preclinical data at the American Association for Cancer Research virtual annual meeting.
Pedal anti human NRP to monoclonal antibodies that we generated from our internal research and discovery program.
These antibodies have the potential to do to be developed for.
The clinical management solid tumors.
There's a growing body of evidence, indicating that the expression of NRP two is enriched in breast cancer stem cells and that NRP to signaling is critical for breast cancer stem cell function and resistance development.
Specifically expression of NRP too has been shown to be high in triple negative breast cancer and linked to worst patient outcomes.
Hey, tires panels NRP to antibodies are engineered to target distinct and specific domains of NRP too.
Through our collaboration with Dr. Horton Mercurial, one of our key scientific advisors.
And is lab at the University of Massachusetts Medical School, we explored the use of our NRP to antibodies in triple negative breast breast cancer models.
The findings demonstrate that one of these antibodies lock the binding a bed just see didnt nerf and then too.
Then just see is highly expressed in certain breast cancers and is responsible for the mediation of tumor progression.
The findings also demonstrated tumor inhibitory effects and increased sensitivity to chemotherapy.
Suggesting that targeting NRP too as a therapeutic strategy for breast cancer.
And potentially other aggressive solid tumors could be useful.
We expect that from this within this panel of antibodies, we will be able to declare an area into Canada later in the year.
Finally, our broad portfolio tyranny sensitivities intellectual property provides the opportunity to contribute to our pipeline to our internal discovery programs and external collaborations.
Our research collaboration an option agreement and CSL Behring and leading global Biotherapeutics company provides a framework to identify up to four new I'd be candidates from our portfolio TRD sensitivities IP.
I'd candidates from our portfolio.
Excuse me due to disruption primarily from the Cobot 19 pandemic, we amended the agreement.
To provide an extension for the first phase of the research collaboration through September Thirtyth 2020.
CSL Behring has provided additional funding for research and development activities to accommodate this extension we plan to provide an update on this collaboration early in the fourth quarter.
So overall.
We're very pleased with the continued dedication determination and focus of our.
Of our employees, which has resulted in the.
The highly encouraging progress we've made to date in 2020.
We look ahead to the remainder of the year, we're excited about the potential that our clinical programs and pipeline hold.
Our pulmonary sarcoidosis draws resumed enrollment and we see forego momentum with the majority of site of sites now reactivated.
Positive outcome from the interim safety analysis of our study and Coca 19.
Permitted the trial to continue enrolling.
And we expect to report data from this important study in the fourth quarter of this year.
Through our partnership with Jordan, we are advancing clinical development of 1923 in Japan with the initiation of phase one trial.
And do too compelling preclinical data with our NRP two antibody program.
We expect to declare an Ivy candidate later this year, which serves to strengthen our pipeline.
Create.
Additional opportunity for value driving catalyst.
With that I'd like to turn it over to our Chief Financial Officer, Joe brought foot to review our financial results.
Thank you Sanjay.
Total revenues were 8.3 million and point 1 million for the six months ended June Thirtyth 2020, and 2019, respectively revenues for 2020 consisted primarily of the 8 million upfront payment under the Kieran agreement.
As previously mentioned, we are eligible for an additional 167 million and payments.
Upon achievement of certain milestones now that Karen has been cleared to begin clinical development work in Japan, we begin to track towards some of the development milestones, which could result in further payments.
Revenues for 2019 consisted of license revenue under the CFO allografts.
Research and development expenses were 8 million and 6.7 million for the six month ended June Thirtyth, 2020, and 2019, respectively. The increase and research and development expenses was due primarily to clinical trial activities for 1923 and pulmonary sarcoidosis and.
How about 19.
General and administrative expenses were consistent between between quarters at 4.7 million and 5 million for the six months ended June Thirtyth 2020, and 2019, respectively.
As of June Thirtyth, 2028, Harry had 41.4 million and cash cash equivalents and investments and we continue to expect to end the year with more than 20 million in cash consistent with prior guidance. In addition, as of June Thirtyth 2020, our term loan balance decreased to 5 million.
And we intend to fully extinguished the stat in coming months.
Now I'd like to turn the call back over to Sanjay before we open it up to Q anyway.
Thank you Jill.
We appreciate all of your interest and continued support and look forward to providing updates in the future.
This time, Jill and I will be happy to take your questions.
Ladies and gentlemen, as a reminder to ask the question you would need to press Star then one on your telephone.
George Your question press the pound cake.
Again, it's thought was asked the question.
My first question comes from the line of that Big dollar with Roth Capital. Your line is open.
Thanks, guys and congrats on the pie that just two questions. The first one the ongoing phase to cover that he has a primary outcome of safety, but for the subsequent studies that you're better off to what you know what do you think Jaime outcome could be.
Are you got to be relegated to something about the at the Hopper Predefine as an approval unclaimed or I do you have some liberty to look at your secondary efficacy outcomes, and then kind of decide what to make your timing wise.
So hijacked Zika, that's that's a very good.
Good question I think one of the things that the FDA is really doing here.
With a lot of the cobot.
Trials is trying to.
Develop at least a framework if not a master protocol on on Whats approvable.
On the therapeutic side, they haven't quite come out yet on things that.
They might be looking for in a phase three trial.
But I think what you can see from some of their emergency use authorization.
Thirdly decreasing hospital stay.
Has led to.
A police emergency approval.
Four Gram does appear.
Mortality of course, 30 day LER mortality is a standard measure we you know we'd look at here that I'm sure. The FCC would also want us to.
Look at in this trial.
Normalization of some of those clinical endpoints.
This is something that when we put the protocol forward.
They like the fact that we're trying to look at hypoxia and seeing if we can normalize things there sooner than later.
And then I think some of the metrics around hospitalization utilization.
Days in the hospital.
Avoiding I see you stay decreasing nice you stay.
All of these are being measured in the current trial.
My expectation is there will probably prioritize 30 day mortality and certainly if you have.
Any signal on being able to discharge patients sooner rather than later I think that that portends really well has a approvable endpoint.
Thanks, Sandy and then we'll find a point here is bubble that he thinks its focus on safety you did they bought out you're not enrolling patients on ventilators, but are you thinking that you may now that patient population a little bit more and would you be using you know what we've seen with some other studies.
Oh the Debbie.
Do you find out patient population.
Yeah, I mean, I think there's it's two prong here number one our biology of our drug. Unlike some of those other drugs being used to pin Mick. Please ventilator patients. We think we are differentiated that.
Our drug works better potentially when you administered early in the inflammatory response.
Directly interfaces and injured and modulating the T cells before you get into some of that cytokine storm. So I think that's first of all part of the attraction of going into an earlier population.
If in fact, we're successful this trial.
As much as you've seen some of those later phase drugs potentially being used upstream and mild.
In quote unquote milder patients.
You could see our drug potentially being used in the ice you setting in that case, yes, we'll have to look at those ordinal skills.
That that you highlighted there.
We didnt have to follow that so much here because we're not focusing on those patients. So I actually think that if we sure activity in this trial given the nature.
Well, how dynamic colder 19 is right now.
My expectation is docs will want to use it even for those.
Insulated patients.
Just because of the nature that we're trying to find good drugs in the tool kit right now.
To help these folks.
[noise] anything that makes sense based on what you said with regard to I'm still see an RFP to regulate it costs more in patients it could be affected even though in some of those later patients as well that could be interesting and then I guess I have one final one actually I'm just wondering if you're going to have.
Another key plant safety analysis says nice to see that you guys.
Got it passed the first with that another one client before this study we filed.
This is the only one that was required in pre planned by the FDA. It doesn't mean that will.
This is a safety study continues to actively monitor safety.
And we have the ability to of course to reach out to our DSMB be as much as we'd like in this study, but as per our protocol and discussions with the FDA.
Given that there wasn't specific experience with our drug in this population.
They asked for a quick look here, which we did you know with the first by patients.
Thank you glad to see they may come Pago from both of these studies.
Thank you.
Thank you.
Our next question comes from the line of Heart Ted thing with Oppenheimer. Your line is open.
Great. Thank you thanks for the questions and thanks for all of the updates Sunday and Joe just a couple of questions.
One is to follow up on the on.
The questions from the.
The PD sandals.
Yes.
The the cost to antibodies from Regeneron for example, arbitrage on getting patients.
You know that are preventing the fashion and both in acute setting also patients who happen to be well you know with Nike.
Well, what do you ever 1973, do you think that could actually go from young few maybe into the our or maybe even even or preventative study I know that.
We need a lot data to see to get there, but could you see that progression.
Sort of similar to what's happening the Coptwenty one time just couple of follow ups.
Yes, we do think that.
If you show activity in this cohort of patients.
The potential to go upstream or downstream into progression of cobot 19.
Certainly on the table.
Particular upstream you know patients that are maybe in the are you want to make sure you're not interfering with their normal host immune response, because probably 80% of folks can.
You know can get through this confection.
There are a symptomatically or with expedia with mild symptoms staying at home but.
But yes.
Our setting could be an area, where especially when hospitals are really full of hospital beds, you're seeing a lot of patients who typically wouldn't have been discharge in the past now being asked to convalescent home, sometimes even with a little bit of oxygen at home.
So certainly that's an avenue for us once we demonstrated activity here.
In the downstream.
As a combo therapy.
I think docs are right now searching for any and all things in the toolkit here to basically address more morbidity or mortality.
In an effort to kind of get get this crisis under control.
Once we establish a safety and some activity in this trial I believe both of those avenues open up for us.
Great.
And then on their pulmonary second instance trial.
Had a question on you guys, you're getting the sites backed off I think you've gotten a lot more information.
From awesome sites have to get by pop in patients.
You are tracking to finish the study do you think that between now and the trial. We tell you might have to make some protocol adjustments are amendments.
Based on just changes from Cowen 19, or you think you can pretty much station trial under the current protocol and read it out with Alcatel and and keep the protocol. So you know Boston.
And have no changes tool.
That's a great question you know at this time I don't expect any any major protocol changes I also think were pretty late in the game right now.
To have another amendment I think one thing to keep in mind when you work in respiratory trials and because this is a respiratory infection a lot of hospitals have protocols in place around vigorous pulmonary function testing because you know that these patients they are blowing pretty hard kind of all over the place. So we're working with those centers.
In the sense that.
There there could be some modifications there.
And capture of some of those Pfcs if in fact, they don't want these patients using be sort of.
Spirometry tools they have in the hospital, so that might be the only other the only a tweak I would I would say is important for folks understand that.
We may have to use slightly different.
Spirometry tools.
Depending on what the hospital wants to do.
Great.
And then the last question I have is just on the ERP two antibody candidate that you're going to declare phone calls you later this year, what sort of publications that we can kind of expect to see from that uniform preclinical setting over the next on six to 18 months.
Well as we just put out really our first you know initial efficacy data, which is rather promising in this triple negative breast cancer model, we want to be able to explore other.
Models other solid tumor models, so I think.
I expect to see more publications looking a little bit more closely at.
Breast cancer of course, but then in other areas, where north to lend to expression to literature has been shown to be up regulated in pancreatic prostate.
Clear blastoma areas like that.
That's where our discovery teams will be looking at those tumor models because that will allow us to not only declare 90, Canada, but then to basically focusing on for example, which two or three.
Tumor settings provide the mill most.
Rational approach to advance.
Two and I'd.
Great. Thank you Sandy thanks for all of the question.
Thanks Todd.
Thank you.
Our next question comes on line of Joe Thank goodness with H.C. Wainwright. Your line is open.
Tons and Joe Thanks for taking the question hope you're all well in your families.
Two questions really just focusing on the trial logistics. So first for the phase one be two way, maybe just a little more detail about sites being resumed.
Need to get any sort of re IR be approvals or what are some of the logistical a rate limiting steps there.
Hi, Joe Good question, no, we do not need to go back to the IR be from from the standpoint of restarting old away at that point so.
That that would certainly that would be an administrative rate limiting step that we're not hindered by I think the main thing here are.
Given that we were recruiting at a.
At a vigorous clip.
Prior to covert 19 with rate limiting here is understanding how many patients will come back into the clinic, what's the density.
While a center can be open some centers will be 100% open another center mice to say, we only want 50% of the sarcoidosis patients that we would typically have roaming in the holes here.
Coming back in year, So we're going to have to observe here at the rate of of screening and enrollment.
As you can imagine just like anything else whether its a.
A school or restaurant or hospital I mean, we're all all of these institutions are working with their local health departments and monitoring their local coded incidence.
In determining how aggressive for or or not they want to reopen here. So that's something that is the next step here, but I think it's a great signs that now.
The lights are on at a majority of our centers. So now it's a matter of.
Observing what happens here, so that we can dive complete enrollment.
That's very helpful. Thanks, and then regarding the phase two cobot study lot of questions of obviously been asked so it's really surrounding.
The conduct of the study and just curious.
Obviously, we're talking about different lines before potentially I was sort of going more into the Yahr for example, but I guess for the current study what are the plans on how you look at concomitant therapies like with regard to maybe as a patient getting a.
Severe or some other steroids or.
Anything under the Sun basically for to treat the inflammatory syndrome.
Yes, so I'm into key clarification, we have is.
Really around Rem density or which you know as an anti viral works very very differently and frankly, probably works better.
Like most antivirals a few administered quite early to interfere with replication.
So from busier is allowed in our study.
And you know.
Hi, it's sort of background standard of care right now at a number of centers. So because we have a placebo arm in our trial, we have to allow what is currently background standard of care.
Next I'd love to zone is being used also here in there as as a pulsatile manner as a background therapy, but that some of those not something that you can also blast the patient with for a long period of time.
So those are the two I would say.
Standard fish of care drugs that are use.
Some of those other monoclonals that are being used more in the ice to you when a patient spicy certain cytokine.
We're not really playing in that space. So you'll see a lot of interference and certainly the recent data from the aisle six antagonists have.
Clearly indicated that those drugs are not working really well so a lot less competition there than there was maybe a few months ago and I think a lot better clarity here one one thing that's come out of our trial is.
Lets patience and docs have been able to manage this this infection little bit better we are seeing folks being.
They are taking their time and putting them on the ventilator. We've seen this we heard this nationwide. So what's happening is there's a greater proportion of patients that are hospitalized and not on on mechanical ventilation. So I think the key thing right now is also.
These hospitalization stays which can be quite long in these patients.
Survival mortality benefit is certainly being observed if you keep people off event, but you still see these patients staying in the hospital quite a bit of times with significant amounts of inflammation.
We think that sets us up really well to be an attractive therapy as we get into.
Coated next year.
Great. Thanks, a lot.
Thank you.
At this time I would like to turn the call back over to Sanjay for closing remarks.
Well, thanks, everyone again reiterate really appreciate the interest.
Lots of updates today and great questions from our analysts will love will be in touching the future.
Thank you again everyone.
Ladies and gentlemen. This concludes today's conference. Thank you for your participation you may now disconnect.
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