Q3 2020 aTyr Pharma Inc Earnings Call
Good afternoon, ladies and gentlemen.
Welcome to the tire farmer.
Third quarter 2020 conference call.
This time, all participants are in a listen only mode later.
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's now my pleasure.
It's over.
To actually dusting attire director of Investor Relations and corporate Communications Mr.
Dr. Stein you may begin.
Thank you operator, and good afternoon, everyone. Thank you for joining us today.
Could discuss eight times third quarter operating results and corporate update we are joined today by Dr., Sanjay Shukla, our president and CEO and Ms. Jill Broadfoot, our CFO on the call Sanjay will provide an update on our corporate strategy, including our clinical program for H.T.Y. arc 1920.
23, and our research programs ignore appealing to or and I P to P or anything to teach biology, Joe will give you 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 would like to remind everyone that except for.
EBITDA for this article 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 company's press release issued this afternoon as well as the risk factors in the Companys FCC filings and included in our most recent annual report on form 10-K, and quarterly reports on form 10-Q.
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 pharma disclaims any obligation to update these forward looking statements to reflect future information events or circumstances.
Comes Kansas 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 2020 results conference call.
As we begin with our third quarter 2020 update.
I'd like to take a moment to acknowledge all of.
Our work and dedication from the entire team our investigators partners collaborators in patients who have risen to the challenge of learning to operate.
Under the unique circumstances that we have all experienced this year due to the COVID-19.
Global pandemic.
With everyone support and cooperation we believe we are having an incredibly productive year, even admit amidst a pandemic.
Now, let's get started with our quarterly review and corporate update.
During the third quarter of 2020 in subsequent periods.
Retire remain focused on our clinical program.
Our lead therapeutic candidate a T Y dollars 1923.
We now have three active clinical trials as part of this program.
Most notably we have completed enrollment in our phase two trial in Cove in 19 patients with severe respiratory complications and we expect to report topline data from.
In this study around the turn of the calendar year.
Our trial in patients with pulmonary sarcoidosis.
And our partner Curations trial in healthy volunteers in Japan, both continue to enroll.
In addition, we achieved key milestones in our research and discovery programs.
Where today.
I am proud to now so we have selected our lead candidate from our NRP two antibody program in oncology.
As we begin I will summarize additional key highlights from the third quarter and subsequent periods.
We entered into a research collaboration with the medical University of South Carolina.
Hey use C and principal investigator Dr., Robert Gemmell to support our NRP two antibody program in oncology.
We discovered new receptor targets for two tier nates entities is from our pipeline.
As part of our research collaboration with CSL Behring.
The receptor targets may have utility in the development of new therapeutic approaches.
For cancer and fibrosis.
And finally, we published a paper in the peer reviewed journal mounds.
Which highlighted the novel technological advances pioneered by our research team to isolate characterize and energy.
Amir high affinity therapeutic antibodies.
We made significant headway with our clinical and research programs.
With steady and consistent progress throughout 2020 amidst the challenges presented by the pandemic.
And we fully expect this momentum to continue through the fourth quarter.
[noise].
And today I will provide an update on our clinical program with our lead therapeutic candidate 1923 for each of our three trials.
I will also comment on our ongoing preclinical research and development efforts for our programs and our two Antioch synthetic biology.
Jill will conclude with a review of our financials.
Yes.
Let's begin with our phase two trial of 1923, and COVID-19 patients, which recently completed enrollment.
[noise], many COVID-19 patients with severe disease experience a form of interstitial pneumonia.
Caused by an excessive inflammatory response in along.
Which can lead to serious in sometime.
Since fatal respiratory complications.
These patients are more likely to be hospitalized.
Require supplemental oxygen.
Mean, mechanical ventilation and spend time in the IC you.
They may also experience longer hospital stays and permanent injury to their lungs.
While.
While we are encouraged by the progress in the development of vaccines and standard of care has improved we believe they will continue to be a need for new and effective therapies to treat the symptoms of patients hospitalized with severe cases of covert 19th.
923, as a potential first in class immunomodulator that down.
Alan regulates average immune responses in inflammatory disease states.
I think 23 has been shown pre clinically to down regulate T cell responses, thereby dampening the inflammatory side.
Cytokine and chemo kind signaling both of which have been implicated in the severe COVID-19 cases.
Further nine NRP two is upregulated on key immune cells known to play a role in inflammation and as we have learned this.
This includes lung tissue in patients who have died from COVID-19 related severe respiratory failure.
We believe 1923 bind selectively to NRP too to.
Normalized.
In system, serving to resolve inflammation and prevent progressive fibrosis.
Thereby stabilizing lung function and alleviating morbidity and mortality.
Data from 923 in animal models of immune mediated acute lung injury.
Demonstrate the 1923 is more effective if given.
Earlier in disease progression.
Further 1923 down regulates T cells, serving to do more than just act on one individual sidecars.
We believe that by administering 1923 earlier in the excessive inflammatory response in cold at 19.
Notably the four patients require mechanical.
Given the ventilation 19.
923 may be able to dampen the immune response and improved patient outcomes.
Based on the strong scientific rationale with 1920 threes mechanism of action and overlap and disease pathology.
We worked very closely with the FDA to initiate a phase two randomized double blinded.
Colin placebo controlled study in hospitals COVID-19 positive patients with severe respiratory complications who do not require mechanical ventilation.
Patients enrolled in the trial.
For randomized one to one to one to a single intravenous dose of either one or three milligrams of 1923.
Or placebo.
And our followed for 60 days post treatment.
The trial is designed to evaluate the safety and preliminary efficacy of 1923 as compared to placebo.
Through the assessment of key clinical outcome measures.
An independent data and safety monitoring board or DSMB be conducted a preplanned.
Blinded interim safety analysis ash.
After the first five patients were dosed.
The study drug 1923 or placebo.
It was observed to be generally safe and well tolerated with no drug related serious adverse effects.
And the DSMB be recommended the trial continue on modified.
These findings.
Earnings are consistent with previous safety assessments of 1923 income.
Including a phase one study in healthy volunteers and blinded the SMB reviews in our ongoing phase one b to a trial endpoints are grosses patients.
Including reviews of cohorts testing, the very same doses being tested in the COVID-19 study.
And last month, we announced that we completed enrollment in this study.
The trial enrolled a total of 32 patients at hospitals in the us and Puerto Rico.
Exceeding the target enrollment of 30 patients.
We expect to report topline data from this study right around the turn of the calendar year.
The top.
When data will include data on safety, including adverse events.
And some of the key clinical outcome measures for all patients enrolled in the trial.
In particular, we will focus on time to recovery.
And proportion of patients achieving recovery.
As well as clinical improvement as assessed by change.
One baseline into Whr ordinal scale.
These clinical outcome measures are in line with those being prioritized by the FDA and similar to those reported by other trials investigating new therapies for this patient population.
Including some that have been approved or granted emergency use authorization.
We're very pleased to have completed enrollment in this study. We believe 1923 holds great promise as a potential therapy to treat respiratory complications.
That result from COVID-19.
1923 is not a re purpose therapy.
It has been rigorously designed and developed a target aderant and numerous.
Change sponsors in the loan.
It has an existing and growing safety database.
And the disease pathology of COVID-19 continues to unfold as one with increasing overlap with 1920 threes mechanism of action.
Our approach to initiating and conducting this.
Brazil has been thoroughly evidenced based.
And we're now focused on reporting the data in a manner with the highest degree of integrity.
By doing so we aim to provide for the optimal outcome and potential next steps for the program.
We're very eager to share the topline results very soon.
Now, let's discuss our phase one b to a trial of 1923 in patients with polling circuit doses, which is currently enrolling.
While many sarcoidosis is a major form of aisle deep.
And is characterized by the formation of granular guidance for comps of immune cells in the lungs if.
Left untreated it can lead to irreversible scarring and diminished lung function.
Current treatments are limited and often in clued treating the inflammation with corticosteroids and other immunosuppressive therapies, which have limited efficacy and serious long term toxicity.
Additionally, many patients do not risk.
Respond.
To this current standard of care.
There remains a need for a novel therapy pubic option for patients with progressive disease.
With a better efficacy and side effect profile.
As a reminder, this phase one b to a trial is a randomized double blind placebo controlled multi.
Puttable ascending dose clinical trial in 36 pulmonary sarcoidosis patients.
The trial consists of three cohorts testing doses of one three and five milligrams per kilogram of 1923 or placebo.
Dose intravenously every month for six months.
The primary objective of this study is to evaluate the safety.
18, tolerability of multiple ascending doses of 1923.
Secondary objectives include assessment of the potential steroid sparing effects of 1923.
In addition to other exploratory assessments of efficacy such as lung imaging.
Lung function assessed by pulmonary function tests.
And relevant serum biomarkers.
Throughout the course of the trial and independent DSMB be conducted two safety reviews.
Both of which had positive outcomes and permitted progression to recruit the third and final cohort of the study.
Which we are enrolling which we were enrolling at the start of the year when the pandemic of March.
At that point, some but not all of our investors investigational sites had to pause enrollment.
We've learned a lot throughout the year as it pertains to navigating patient enrollment and conducting clinical trials in this environment.
Including with this high risk patient population.
We've worked with each site and patient to adapt to.
The challenges that presented in order to ensure patient and provider safety, while maintaining the integrity of the trial.
When needed we allow for the use of alternate methods safety assessments, such as phone contact.
And the use of.
Local labs for example for Spirometry testing.
These adjustments were within the FDA guidelines on conducting clinical trials during the COVID-19 public health emergency and we believe.
They have been instrumental in permitting the trial the procedure.
In August we announced that the majority of our sites of a pause that resume clinical trial activities.
These sites continue to screen.
Dose patients, including in geographic areas that have experienced a recent increase in covert 19th.
We plan to provide an update on the expected timing of the results. Once the trial has fully completed enrollment.
Well finish the discussion of our clinical program for 1923 with a few comments.
On our third trial, a phase one study currently enrolling by our partner curing in Japan.
Earlier this year, we entered into a collaboration and license agreement with Karen for the development and commercialization of 1923 for idled. These in Japan.
In order to conduct clinical trials.
So the new therapeutic drug candidate in AILD patients drawn as required by the jacket Japanese regulator.
The pharmaceuticals and medical device agency.
To investigate safety and pharmacokinetics and the Japanese population this.
This requirement remains.
Despite the exists.
Getting data for Mnine hundred 23 from trials conducted in the Us and Australia.
In September showing dose the first subjects in this trial.
Which is a phase one placebo controlled study.
Evaluate the safety pharmacokinetics and Immunogenicity of 1923.
Known as K RP Dash car 120 in Japan.
In 32 healthy male Japanese volunteers.
This trials currently enrolling.
And it's not experienced any delay as a result of the pandemic.
We look forward to the results, which upon successful completion.
Permit yarn to initiate patient trials trial these in Japan.
Now, let's turn to our research pipeline, starting with our NRP two antibody program, which we believe has great potential to produce future value driving candidates.
As a reminder, NRP too as a company.
Wouldn't therapeutic target in the areas of oncology and inflammation.
In cancer NRP too is up regulated on a variety of different solid tumors.
Hi, NRP two expression is linked to worsen patient outcomes in many cancers and may contribute to drug resistance with current therapies.
Finally antibodies that can selectively block different NRP two signaling pathways they have there.
Our beauty potential.
So are you tired developed a panel of fully humanized monoclonal antibodies to selectively target distinct domains I'll, then RP too for diverse therapeutic applications.
Today.
We are proud to announce our lead investigational new drug or high end de candidates from this panel K T Y R 28 10.
28, 10, specifically and functionally blocks the interaction between NRP too and one of its primary liggins veggies.
Hi, Jeff.
The role of NRP, too and VEGF signaling in the tumor microenvironment.
And it's important in the progression of certain aggressive cancers is becoming increasingly validated.
Earlier this year, we presented preclinical data at the American Association for cancer Research virtual annual meeting.
From a collaboration with Dr. Arthur material, one of our key scientific advisors and his lab at the University of Massachusetts Medical School.
This data show that 28 10.
Demonstrated tumor inhibitory effects.
And increased sensitivity to chemotherapy in human derived organizations and other in.
Metro models of Triple negative breast cancer, and extremely aggressive cancer, where NRP too has been shown to be highly expressed in many patients are not responsive to currently available treatments.
These findings suggest that targeting NRP too and the VEGF pathway may be an effective therapeutics.
<unk> packaging for breast cancer and potentially other aggressive solid tumors.
Based on this and additional data we have generated internally over the past several months in various tumor models.
We will be targeting 28 10.
For therapeutic application in cancer.
With high Andy enabling activities starting immediately.
In addition in addition to advancing 28 10 in cancer, we continue to explore and optimize the capabilities of our antibody engineering platform.
By leveraging both our internal expertise and external collaborators.
Dr., Robert Gemmell Professor of Medicine Emeritus in the division of Hematology oncology and you'll see.
He will serve as the principal investigator.
For the collaboration.
Which is focused on evaluating antibodies that selectively target specific NRP to isoforms for potential use in the.
The treatment of lung cancer.
For NRP two is also this year.
Lung cancer is the most common cancer globally.
The leading cause of cancer death.
Despite currently available treatments many tumors become metastatic.
Or develop resistance to targeted therapies.
The development of new therapeutic strategies.
Which may offer alternative mechanisms to existing therapeutic approaches and reduce drug resistance.
Our greatly needed.
Dr Demos and noted expert in the field of NRP to biology, and its role in cancer.
This research focuses on the alteration of genes during long and.
Kidney cancer development.
We look forward to collaborating in this area of research.
With Dr. Gamble.
Our NRP two antibody program is a product of the state of the art antibody discovery platform that a tire scientists have developed.
This work was recently recognized through the publication.
Question of a peer reviewed article in the journal maps.
This sort of article highlights novel technological advances pioneered by our research team.
Isolate characterize and engineer highest affinity therapeutic antibodies.
Our team continues to deploy these and other cutting edge antibodies.
In summary techniques to generate future pipeline opportunities.
This research was conducted in collaboration with absolute zero biologics.
A leader in antibody technology and drug discovery platforms.
Who served as co author of the publication.
Finally, I will finish with an.
An update on our TR any sensitivity discovery program.
Through our research collaboration with CSL Behring, a leading global Biotherapeutics company.
We have discovered new receptor targets for two tier nascent stages from our pipeline.
Identifying target receptors for an extra cellular tyranny synta.
Helps inform our discovery and development activities by providing additional focus towards relevant disease pathways and potential therapeutic applications.
These new receptor targets that we identified may have utility in the development of new therapeutics to treat not only cancer, but.
It also fibrosis.
We expect to present findings from this research at a scientific conference in the very near future.
We continue to analyze this data.
From these intriguing findings and are in discussion to map out next steps in collaboration.
With our partner CSL.
Overall, we're very pleased with the progress we've made to date in 2020.
We have momentum with our three active clinical trials for 1923.
We initiated and completed enrollment in our Coca 19 trial, and we expect to report topline data from this trial very soon.
We continue to.
Enroll patients in the third and final cohort of our trial in patients with only sarcoidosis.
And our partner churn is enrolling its initial study in Japan.
Today, we declared the first I'd candidate from our NRP two antibody program 80, why our 28 10 for oncology.
And Additionally, we have discovered.
New receptor targets for two tier nascent details from our pipeline.
When we look at our progress this year compared to where we were a year ago were highly encouraged.
We now have three clinical trials, a preclinical program that has advanced a new R&D candidate.
And two tier.
Any sense of taste discovery initiatives that has advanced.
As we make our way through the final quarter of the year.
We're excited by our progress and the potential that our clinical programs and pipeline holds.
With that I'd like to turn it over to our Chief Financial Officer, Joe Broad foot to review our.
Financial results.
Thank you Sanjay.
Net loss for the three and nine months ended September Thirtyth 2020.
Lets $6.6 million and 11.3 million respectively.
Compared to 5.6.
$6 million and 17.6 million for the same period in 2019, respectively.
While the third quarter net loss was slightly higher than prior year due to increased clinical activities. The decrease in net loss for the year was due primarily to 8 million from.
My.
Revenue received under the current agreement.
Under this agreement we're eligible to receive payments upon achievement of certain development regulatory and sales milestones, we expect to see the first of these milestone payments beginning in 2021.
We ended the third quarter with 36.1 million.
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 also as of September Thirtyth 2020, we had $3.1 million of term loans. However.
On November 3rd we fully rate.
We paid our term loans and retired our debt.
We are happy to report that we no longer have any debt on our balance sheet.
By paying off this that we are eliminating 8 million per year and principal and interest payments.
No 2020 actually included close to $10 million in debt.
Payments, which we will not have in 2021.
We are very pleased with what we have been able to accomplish while upholding the responsibility of the 20 million of debt that was secured back in 2016.
We expect to have the opportunity for a highly effective management of our cash.
Burn in 2021 and beyond.
Now I'd like to turn the call back over to Sanjay before we open it up to Q and a.
Thank you Jill.
We appreciate everyone's interest and continued support and look forward to providing updates in the very near future.
At this time, Jill and I will be happy to take your questions.
[music].
At this time in order to ask a question press star one on your telephone keypad.
To withdraw your question press the pound key.
Please stand by while we compile the killing a roster.
Your first question comes from the line of Hartaj Singh with Oppenheimer.
Great. Thank you for the questions and thanks for the update.
Thanks Daniel.
Just a couple of questions one.
On his focus on.
Teradyne towards making 23 Colby thanks.
The trial, there options or what I'm looking at the.
Your primary and secondary endpoints in control of our cost you.
You got from.
Oh, a few of them, but 60 day four of them are deed 14 or discharge or anything to report the results.
Also to slightly trial.
60 days I guess roughly.
After last patient enrolled but how to think about some of those year end.
Endpoints that are shorter.
Is there a potential for an update if the results are better than expected sooner than that or really just you got to wait.
Well that 60 day period, the optimal last patient visit to unite to read it out and I just got a couple of follow ups.
Yes.
Yes. Thanks shortage, we actually are going to be prioritizing I would say the first 30 days of end points. So when we look to cut through the data.
Based on where.
Sure we saw you know.
The sort of enrollment curve.
We feel pretty good about being able to read out.
Really most of what what's occurred in the first month of the trial.
We could certainly look at cutting things at different time points.
But based on the trajectory of how patients.
Old and how they basically did in this trial.
We're going to have a nice dataset I would say prioritizing that first month.
It's that it's that last 60 day visit where.
We wouldn't necessarily.
Have a full dataset, but that 60 day visit is largely safety.
When.
Enrolled 18, its nature as a safety follow up.
So we feel pretty good about being able to have a complete.
Message really by looking at.
Those those those those data past that first month.
Which is I think in line with.
Most other companies on what they're presenting.
Okay, great. Thanks, Sanjay and then.
Just a question on the.
The former executives this trial I know you're really starting the third cohort.
With a readout sometime first half next year, but.
Has there been any changes because you had to pause enrollment.
In some of those patients.
I don't might not have gotten a dose from mr. dose in terms of your protocol.
Will anything change in the analysis plan for for the Palmer second dose. This trial when you eat up and I got another couple of after that thank you [noise].
Yes, we're not we're not we're not making changes to the to the statistical analysis plan as I said they are sometimes.
Times can be some operational.
Things that our team is allowing.
Within the protocol individuals to enroll and manage and followed in the trial, we've learned quite a bit about how to.
Jump to those hoops right now working with different centers.
All.
My while keeping patients enrolled in our trial and trying to minimize.
Any kind of missed missed visits miss dosing things of that nature. So.
So I can tell you that since we restarted.
We've done a really good job of.
Sticking to good operating.
All the guidance practice integrity in our trial.
And I also think that.
We've been able to successfully.
Seriously dose these patients.
And I think Thats really put a job that our clinical operations team has done a really great job here on navigating there's some.
It's kind of a different environment. We're in so that we minimize the things at that that you point out. We we we don't want any of that to happen.
And we think we've done a great job there.
Yes, essentially will just sort of second kind of surge of infections and hospitalization.
Pulmonary sarcoidosis patients.
Have either.
She is with the long.
Could there be any change in the trajectory of this third cohort enrollment with the.
The SEC this kind of surge going on right now.
We do not anticipate that I think that has there's a couple of reasons for that number one.
Have you been able to figure out basically how to keep these patient safe manage through the trial.
And we have evidence of individuals being able to dose through and meet all of their.
More or less all their commitments in this trial.
Safely so by doing that at one or two sites.
The remainder of our sites have seen that and now we have a really nice ability to operationalize that across all our studies, even though some of them right now are going through.
A cresting of cases locally so I think we've implemented some real time feedback.
As I said it has.
Impacted our statistical analysis plan, it's just involved us to be a little bit more nimble on some operating elements.
And we do not expect even at the current rate of of covert cases flaring all over the country. It is not slowing things down for us and we don't anticipate it will.
Yes.
Thank you and then just on the on quite interior 28 10.
You had mentioned breast cancer is possibly the first area you could going with your R&D would these be sorry.
What we do.
What types of breast cancer patients and be the hormone sensitive or yeah.
Any thoughts there it's still too early in terms of where you are in the R&D from process.
I think we had obviously some some really nice data that we presented at a CR in triple negative breast cancer. So this is a a sub cohort on a more aggressive cohort of breast cancer patients.
So I think thats something that we definitely want to follow up on.
With our with our new collaboration with Dr. Gemmell.
He we see entrance into lung cancer and potentially kidney cancer.
But as part of our R&D, enabling work part of this is focusing in on which tumor types does 28.
10 show the best amount of.
Early efficacy.
So I will tell you that now the antibody we can now focus in on where we think it will be most effective that's those are.
Some clues on some early.
Tumor environments that we're looking at a little bit more.
More intensely triple negative breast cancer also lung cancer, and and also looking a little bit renal cell carcinoma as well.
Okay, and then do you expect to file that Andy sometime in 2021 are you or is it when when when we can we get some visibility on just when the filing will.
Uh huh.
We think we can we can file or at least get prepared to file right towards year end next year, I think I think weve advanced our knowledge that it's not going to take us 18 or 24 months.
We're looking at more like a a one year timeframe here.
So look.
But early to provide guidance and the exact hi, Andy filing date.
So we think that.
Based on the data we see if we continue to track and see.
Similar kinds of efficacy signals throughout the course of the the first half of 2021, I think we'll be in good shape towards the tail end of 20.
A little.
To to potentially file and I'd Ah ha or even do so right away at the beginning of 2022.
Yep, Thanks, and my last question is to jail.
Just on cash burn for next year.
You know assuming if you're caught me thanks in trials.
Towards the latter part of this year.
You don't have those interest payments next year, how to think about just cash burn I know that you know actually only a few months away from the fourth quarter call JP, Morgan et cetera, but just how to think about cash burn floor for next year from an Opex perspective, Joe again, Thank you for the question.
Hi, hard tags and that's a good question.
Any.
There are potentially going to be a lot of changes next year in our operation compared to this year next year, we could potentially be getting ready for a registrational trial for pulmonary sarcoidosis.
We might be gearing up for Covance, which would require.
Hi, or additional manufacturing so we're actually looking at each of those activities and.
And obviously, we're in our budgeting process right now so it is too soon to give guidance.
But I do think that given success in planning for success with these trials.
We should we should be spending more on ramp.
Ramping up those clinical trial activity and or manufacturing.
No no that's very helpful. Thank you so much.
Your next question.
Comes from the line of Joe Pat Kenya, with H.C. Wainwright Wainwright.
[noise], Hi, Sanjay and Joel Thanks for taking my question and good evening.
Wanted to focus on my question. My question is really focusing on the speculative realm here, so assuming that the covert study or you know turns out positive.
Jill just sort of touched upon this as well with her comment.
You know based on your wish list then based on regulatory feedback what do you consider as next steps regard to study wise.
When could you potentially look towards in any way and what do what do you.
You have in place currently for manufacturing purposes, and what do you envision meeting thanks.
Yeah, Hi, Joe.
Great questions I think with good data a lot of good things can happen.
With regards to first off accelerate.
Ending into the next trial.
We have to provide a manufacturing plant and the ability to move into that trial, rather quickly when we first met with the FDA. So.
So we do have.
Drug product available to quickly move into that trial, if if we choose to do so.
Number one.
Number two getting feedback I think and the potential for emergency use authorization, I think where you've seen a lot of therapies out there even was.
With with modest effects generate authorizations, yeah, even improving hospital stay by one day.
Is viewed as a game changer in the current environment as.
As we are in crisis mode.
So we do think that if.
If we can show benefit here, because we've run a placebo curve rigorous placebo controlled trial under the guise of the FDA and we focused on the very same endpoints that have garnered.
These sorts of authorizations, we feel pretty good about the regulatory climate to move forward.
Accessing other forms of programs things of that nature, you see a lot of companies being able to also accelerate those discussions we would expect to need to do some of that when we start to think about.
The commercial supply of 19 twenties, we targeted to COVID-19, so while we're we're game ready for the next trial or if we have good data.
I would expect that we would rapidly advance discussions.
With with the government and there you have seen.
Quite.
Hey.
And openness to excel.
Accelerate manufacturing for small and large companies assisting.
With that and we are ready for that and we would expect that if we have good data.
Great. Thanks for those details Sunday.
[noise].
Your next question comes from the line of D Challah with Roth capital.
Capital partner.
Hi, guys. Thanks for taking my question Congrats on the update I was really happy to see that you now have no selected at 90 candidate or a quick look like.
For.
You are in your potent anti body 2810, and so really excited to see that I think we can officially call your audio immune and oncology company. Now also Sunday I think I heard you say that you know lot of the R&D, enabling studies are underway or about to begin immediately so happy to see that as well, but I think.
One of the things often discussed early on is that you're kind of like the leader in the new opposed states right. Now. So do you plan to do you know an event or something like that what Q out the kind of educate no investors, but the clinical community because I think they'll be well important in terms of eventually initiating clinical studies and getting some support for that.
Yes, thanks, Thanks, Ed, but absolutely I think as we are the leader in Norco in biology now.
There and we've also got our arms around we will significant expertise both internally with how we manufacture these antibodies and really are getting recognized.
Now around how.
Efficient and from an affinity point of view, we really are producing good technology here, and then externally being able to work with the best and brightest who have decades of experience in Northern Ireland research people like Dr. material Dr. gammell, our absolute.
As we start to generate data and show activity in.
More of our our tumor experiments. These are things that we like to be transparent, we'd like to publish we'd like to put in abstracts, we'd like to get out there at medical conferences and then once we have a repository of good data there.
The movie I think it makes sense to pull together.
The investor community and really.
Okay, and really outline all of the all of the things we've seen we're building. This program very much in the manner that we systematically and carefully built are at 1923 program.
Thanks, Andrea and then another one I had another pipeline development I was really glad to see the recent announcement.
On your update in terms of targeted Densification with your Chinese does this platform in collaboration with CSL I think a lot of people to the platform. I know you have the partnership that we hadnt heard much news permits is really nice to see.
As you know that some of that effort is now paying off how else can we see you know some of the benefits of that you know when is it you know perhaps going to enter clinical studies were additional clinical studies and then you know anything.
Anything after that.
Right so.
As you can imagine these are.
Pretty exciting.
Insights two years ago, we discovered 1923 buying center build too and that really launched.
Multiple programs from that.
These results. These findings of course, we're working closely with our partner around next steps, but we also want to.
[music].
Get this data out in a scientific conference rethink their meaningful it's important.
It's going to.
Transform.
A whole nother pipeline opportunity for us we want to do that in a rigorous scientific setting. That's when you will get to know what these receptors are as I said.
Really nice signals there that can point us in other directions in cancer and other areas in fibrosis.
Both things I think stay tuned we like to debut this in more of a scientific setting, but it was important for us to get this out as we had committed to giving an update on.
Where we were with the CSL collaboration.
Things on Dan and you talk about actually I was just talking about educating for NRT too, but it sounds like you know that this pipeline to Bonnie to actually have a full R&D day. So I'm looking forward to seeing what you guys do it some of this work, but I think a lot of both are interested in the near term.
Tim clinical data, that's coming up there just clarification I think on a question a hard time asset sale for the read out that's coming up after the Carbonite team program. Our study with 1923 I were looking at 30 day data I'll leave that to you know get anything less or more than that.
Yeah, I think we're.
You would we'd be look we prioritize those clinical endpoints.
We're going to be looking at we're going to be able to take it out to about.
30 days, we should have a complete data set for all of our patients at that point.
Okay.
From us from not only an activity standpoint, but also a safety standpoint.
Point.
And then the only thing really remaining would be some of our.
Bio analytical work some of the cytokine that stuff will come in later with the 660 day safety data and that would be an update but I think at this topline.
This topline results, we will be able to.
To pull together really all of these patients and how they've done.
In the critical period, which is I really think is in that first two to four weeks of of being hospitalized.
So.
This is something that I said.
We'll we'll we'll be looking at right at the turn of the calendar year.
To come on the exact date is still pending but we're looking at that that timeframe feel pretty confident we're going to land right there.
Thank you and then just a final one year and I don't think you have an answer for this one just yet but.
The pulmonary sarcoidosis study.
Sounds like things are progressing are you at the stage now.
Well you can provide more granular details are still tight.
Timeline as to when we can see the data from that where you provide that outlet at a later time point.
Not quite yet I'm close, but stay tuned we wish we had what I want to be able to do is once we.
Effectively dose that 36 page.
Jason and I know exactly when that and that is confirmed I'll be able to then.
Highlight exactly when you know what day next year, then we'll have what quarter next year, we'll expect data so.
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That that update will be coming.
Once we dose that 36 patient.
Thanks.
Guys really appreciate at this is this is really exciting.
Thanks for the questions.
And there are no further questions at this time I will now hand, the conference back over to Mr. Sanjay shoot GLA.
Well. Thank you everyone for your time.
Listening to our progress and we look forward to being in touch.
In the in the very near future.
Everyone say safety well thank.
Thank you.
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