LIFE - Earnings call transcript Q4 2019

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the aTyr Pharma Fourth Quarter and Full-Year 2019 Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions]

I would now like to hand the conference over to your speaker, Ms. Officer. Financial Chief Broadfoot, Jill Please go ahead.

Jill Broadfoot

update. good Thank joining XXXX Thank corporate for everyone. today you, operating to and full-year and us and discuss you quarter afternoon, aTyr's results fourth

Shukla, We our are by joined Dr. President CEO. today and Sanjay

handing financial update financial antibody On strategy, back our call then program. it ATYRXXXX, recent I including provide Kyorin positioning with the of corporate licensing development will on agreement questions. to the results clinical Pharmaceutical Sanjay will current open call, for our up Sanjay before and an our the and to review our the any

Before materially to statements Private under harbor provision for made the Act except Litigation I statements call questions Company's we the and the Form statements as recent safe quarterly involve results the on Reform and forward-looking risks management conference and actual this report afternoon factors such well to disclaimer differ in begin, our statements to on that press responses would remind included and everyone issued uncertainties filings annual Securities Form from can of XX-Q. forward-looking the by Company's the in statement reports the forward-looking fact, of risk XX-K XXXX. on like those in release cause see of SEC These historical this that as Please are most statements. in

the date statements made, be not forward-looking should are placed on as forward-looking they reliance of speak facts Undue underlying change. which and statements, as may these circumstances only

future information, circumstances. update Pharma any to reflect forward-looking by these statements aTyr required to or law, disclaims as Except events obligation

turn the call now I over to will Sanjay.

Sanjay Shukla

you results call. Good conference year-end us afternoon, for joining Jill. for you, everyone, and thank Thank XXXX

our to value-creating unmet important the and pipeline strengthened sheet balance aTyr development these and high therapies us first-in-class our programs further milestones. clinical XXXX, and preclinical During to need potentially for diseases advance with towards progressed program significantly potential enable of of

important two product we spoke we ATYRXXXX. last November, milestones candidate, lead for Since achieved in our

safety Phase study tolerated with trial either to or from interim XXXX serious with in showing results well Ib/IIa announced safe observed drug-related we no First, drug, events. patients adverse and generally was our clinical be pulmonary sarcoidosis, placebo

we second, to for development Kyorin and million of milestone in XXXX the worth commercialization and partnership strategic Japan, Pharmaceuticals first with in entered $XXX payments. And our up upfront

In addition, let recent from me news review current our this other quarter.

including the or published a the range Immunology and engagement essential broad Cellular ILDs. synthetase the diseases that immune a states, cell tRNA in Journal histidyl in lung Nature highlighting We modulation paper in role interstitial or HARS Molecular of disease of plays

high-throughput bi-specific build a as XXXX this productive was We approximately platform proceeds grant common scientific and million early a Hong raised We leading company. further the has antibody this announced out continued of of $XX.X award And NRP-X we on week, Dr. finally, earlier to from antibodies, a the momentum a to year in us the gross cancer a Mercurio, XXXX. government researcher of stock. public development a appointed advisor building Kong for offering Arthur development program. of for

preclinical details Jill our further conclude a with development advancements lead will synthetase and our progress regarding provide of will candidate, our position. and biology. ATYRXXXX research tRNA I Today, in with financial review on NRP-X therapeutic efforts and

want COVID-XX I operations. Before outlining our effect on these details, to the of the pandemic discuss

keep possible. and with as disruption to a little employees personnel efforts best our as utilizing maintain with and our site patients, are safe investigators, compliance We government directives business

in seeing are the clinical negatively effects Clinical by our we studies impacted and across are the globe study. also being XXXX COVID-XX

We are for enrolling currently X cohort of patients our study.

curtailed enrollment clinical trial completion impacted has many as have However, been of operations. sites

enrolled existing be will some patients delayed. for dosing continued addition, In

closely investigators. work to sites continue and will We with

Therefore, it about this results in this Phase we our Ib/IIa time. of we more results. to this study trial see what difficult topline the learn our However, of at is Everyday, pandemic. estimate clinical expect will the timing delay delays impact pandemic type to we of

remotely business provide as our will operating are and further health we We updates crisis this unfolds. public

to I'll XXXX a of program. our Now return review

XXXX Ib/IIa of reminder, clinical pre-planned, evaluated randomized, December, being currently multiple results is pulmonary of ascending announced patients. dose tolerability, a placebo-controlled, Phase in trial. primary and the double-blind, XX sarcoidosis of analysis we the a trial As interim blinded In a in endpoint safety our

were Phase Study a results had dose minimum I safety no sarcoidosis announced Interim XX with who drug. observed received healthy of be well in results blinded tolerated generally to study drug-related of volunteers. consistent with safe drug pulmonary data our one patients was from and study SAEs,

initial primary the trial. indication We’re an findings, these encouraged provided early study safety endpoints and of meeting which by in for XXXX tolerability

earlier million year the received Further achievement Japan. agreement this commercialization are net an upon and an as in $XXX and came as royalties we $X of the regulatory our license tiered validation to XXXX and XXXX milestones, we certain collaboration a development, upfront million for aggregate the agreement, announced with development on payment in to when Under terms Kyorin well receive of program of sales for the additional eligible ILDs of sales. up and

strong the an in weighted Japan. the the leading with to respiratory-focused all development commercial clinic. company. covering structured Kyorin allow footprint be They more We key existing of side this and value as presence, program realize us on R&D ILD have the to progresses the pharmaceutical is partnership from a to milestones through a centers

believe significant XXXX As our development development us enhance Japan, need helps further ILDs. and area these in accelerate capabilities the of with commercial potentially U.S., an collaboration and lives other the will in conditions. of in patients to and Kyorin’s improve ability validates represent unmet ILDs We this serious

look activities for we of be research, forward for for has XXXX. a strategy will for and development the to We outside advancement initiated PMDA. Japan activities Pharmaceuticals responsible by working regulatory, with XXXX be as dialogue partner will us the the and remain regulatory with Global or operational in including all Agency Kyorin relevant development, Kyorin led Devices of funding and activities, all including the executing and Japan, Medical development manufacturing. strategic will and commercialization agency, marketing responsible

for significant therapeutic resulting preliminary our can disease results in interim lung opportunity pulmonary the towards trial favorable Pulmonary safety advance slow of present sarcoidosis. treatment lives establishing a the XXXX allow of sarcoidosis decline the that to and The halt novel other and to us lung or option progression evidence function. as interstitial a approaches diseases potential with ideally patients improve

other to allows Our partnership potentially indications. development XXXX ILD us with of in Kyorin the accelerate also

opportunity on exception lack is and clinically focused unique a there a idiopathic options are with These inflammatory of ILDs, therapeutic all IPF, least ILD. where proven of development fibrosis activity. inflammatory represent or of of We limited the pulmonary which ILDs is forms the area

believe represent our believe $X areas $X We proposition these opportunity Overall, our billion is to interested conditions a ILDs combined in of significant XXXX. the very leading compound. in for value billion pulmonary and remain could market experts we

with potentially is immune the cancer towards pipeline and to efforts of inflammatory developing various expression understand therapeutic NRP-X diseases discuss for cells outcomes. tumors, new linked gears in of novel differentiated target NRP-X patient and and expression a shift in our other opportunities. ILDs NRP-X Let's is targeted to worsened move and of role inflammation outside disorders, NRP-X tumor up-regulated, during high we forward whose as both

use in position expand potential receptor of collaborations, these specific We NRP-X we our selectively Through therapeutic targeting have leadership currently continue institutions. collaborations of scientific are active the the and with exploring academic NRP-X diseases. in to context leading

Our panel domains of the possibility multiple antibodies product in-house opportunities. offer distinct developed signaling new, of targeting compelling NRP-X well-differentiated developing

company. Mercurio scientific We Arthur the have advisor to key recently a partnered as with Dr.

Results explored with collaboration Mercurio’s Association working models, included It of one been collaboration, of we for has been abstract. by many the University Meeting. previously We've a our at School. Dr. in Medical at the one Cancer lab of its from where accepted is use in NRP-X cancers breast NRP-X American for antibodies Research the Annual are Massachusetts poster of Under this triple-negative the the implicated. cancer

keep you as will when data be We to can shared. this important updated

resistance, also novel the actively metastasis and cancer NRP-X number to are in exploring. selective antibodies, for mediating which a growth, addition In of role there are we well-established drug NRP-X applications of

that grant we for approximately to BioPharma antibodies. Kong Hong bi-specific build together the development of the platform Technology week, high-throughput a Science subsidiary, and Limited, Hong this of Earlier Kong of has $XXX,XXX University a awarded our announced Pangu with been

which differentiated opportunity further will as research drug in including is on this focus a antibody potentials NRP-X co-receptors elucidate therapeutic diseases, in over-expression strongly NRP-X the implicated. cancer Initially to presents A targets. approach its and bi-specific

CCRX, The it make including complexes. simultaneously integrins of the both target and various like for that fact can a that co-receptor with chemokine target NRP-X interacts prime signaling the bi-specific certain receptors and antibodies receptors activity molecules, directly modulate plexins,

of the great The aTyr remaining this place the being value is and Partnership The costs, Innovation collaborated grant project HKUST fund Program. approximately estimated will many We've XX% for the under Research relationship. contributing funded with two-year and Technology long-standing years Hong by Kong project the total the XX%. on with Government's Commission

research a our CSL progressing collaboration biotherapeutics Finally, company with is global planned. leading as Behring,

of a an synthetase call. on providing portfolio IND collaboration our plan update quarterly of reminder, tRNA We collaboration from to this candidates is goal new up the As identify four to our on this IP. on next

as look we completing Overall, our crisis. COVID-XX our possible forward given progress encouraged to expeditiously and with current trial the very are as

creating populations, opportunity long-term Additionally, key and a internally biology to advancing while we strategic around unique with tRNA synthetase both efforts I value for our the significant believe our same pipeline and at collaborators. NRP-X underserved time and are have shareholders. help

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

Jill Broadfoot

fees the XXXX, agreement to have collaboration Total million are of auction option our if receive $XX were Thank revenues $X.XX you, X up by Sanjay. total $XXX,XXX from CSL, XX, total CSL. where to programs revenue all December consisting program, collaboration up ended synthetase in we of to research also and synthetase and of the opportunity with year for advanced a million a per

decrease a result offset million increase our Scripps decrease in as costs. Research $X.X to Research December $XX.X $X.X collaboration research a Phase lower XXXX, $XX we and product for mainly of and due related was personnel were to related a November development respectively. million in of million manufacturing reduction XXXX, in a $X.X million decrease with years decrease Institute XXXX in terminated a the our were million XXXX million initiated of force XXXX, associated and The trial. $X.X of The XX, costs million Ib/IIa decreases clinical which $X.X research $X.X with and an million a development in by to costs associated The decrease primarily preclinical expenses of expenses ended and effective May

General expenses from ended the XXXX million May a XX, The fees. million reduction million $X.X decrease the $X.X were $X.X XXXX, primarily years $X due respectively. million of decrease in and XXXX December a force, professional decrease to for was in and administrative $XX.X and million and

$XX.X had and connection investments. year, with of cash, in we we XXXX, in the million Agreement. payment million As cash an XX, the of the end December received Kyorin Subsequent $X to equivalents upfront

mentioned, also of under in as in million we the to their opportunity As $XXX have the receive Kyorin Sanjay Agreement, development additional progresses Kyorin milestones XXXX.

offering $X.X of offering, reach public we equivalents debt also believe also year-end which We XX, our potentially of cash us during raised $XX the XXXX cash early our recently of Also milestones of as long-term upfront Including value-creating $XX in to have resources reflected proceeds to end the allow at proceeds and and cash, will common public $XX.X in Kyorin decreased million year-end million stock, gross investments cash XXXX. in comfortably the our XXXX. XXXX will balance. from cash, of the approximately we these from first December the estimate at XXXX. quarter million million We significant year-end and not from is

by over combination the are over million November, in to to comfortably XXXX. on proceeds grants, cash. We revenue, continued this target XXXX fully year us equity of believe with sufficient have saving end measures and gives repaid our We cost licensing cash $XX loans

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

Sanjay Shukla

Thanks Jill.

patients. I call several and month, of the questions XXXX potential opening and questions, have Before to investors highlight, about queries from want COVID-XX last the treating we received in for analysts over the utility

more COVID-XX damage can the and to the lungs. does about body are virus, this the we continues, outbreak particularly to what As learning it the cause it

demonstrated care. of patients to XXXX, Although, people including potential subset with respiratory admitted for a acute intensive models COVID-XX of of no Based our many of has a symptoms in we lung ARDS on distress syndrome, help acute patients, of to ARDS. have injury only be understanding mechanism actions believe number or have COVID-XX its XXXX animal or the may develop we effect who where efficacy, need develop the and mild symptoms,

development potential XXXX, engagement We is on FDA this setting. including of formally approached clinical the the have in This preliminary. testing,

it our at investors with help However, let looks we're to public as this ways know crisis. we to company health for where felt was important

appreciate will look continued in We providing informed future. keep with your agency forward discussions interest and our the updates to We as progress. you the and support

I At happy this to be time, Jill take will and questions. your

Operator

come first Zegbeh from Jallah with Capital [Operator Instructions] question will Our Partners. ROTH

Zegbeh Jallah

updates. the for Thanks

clarification, Just be also the you are do all will expect for for And sites? than the longer take And currently XXXX online, them hold? Or they at will do come back of all some up same new on sites them to time? you when consider opening others?

Sanjay Shukla

Zegbeh, Thanks, for the Sure. question.

to dosing continuing other clarify, to various at all centers centers that not are just they're take of if dose. have being we're both are a halt centers screen different they decision aggressive. a There They're who of pause those said, to So some that on continue There going little There more other screening. are going are off-line. stages. where to aspects, to made we're and bit they're but sort little maybe

I going risk dependent it's resources the would center, minimizing while, time, they patients. what to basically for to the anticipate burden COVID-XX and see at of be center reapportion on that is each same really

to going it's vary. So

to what on bit sort progresses. have of impacted you how get see be any is, anticipate that been little centers more can if open whereas our able they'll we'll this a are up, handle think there better of maybe hopefully, actually kind hopefully, as site, I others, a with trial, to our those of just have this,

going some be So variation there. to there's

Zegbeh Jallah

you. Thank antibodies? any now grant in comments neuropilin and now, additional another to based HKUST, the then you with indications that awarded on Pangu that acceleration of anticipate you hand follow-up And preclinically? The to here. on was what develop And or grant know just do an anything efforts

Sanjay Shukla

Sure.

that receptors of to potentially job This antibodies will that but of A a platform neuropilin-X those things nice also not are to co-located antibodies like create specifically a kind grant receptor, allow integrins done NRP-X. looking angle and had is and in-house proximal that those important plexins, receptors. we subdomains at some bi-specific of adjacent, another us platform. other target to is neuropilin So only a developing specific here neuropilin-X. And include those bi-specific

And if those an about additional to you think multiple pathways, mechanism have now you agonize potentially pathways.

be on a project our another the that pathways HKUST We with what's but once. with is might currently us Hong to even approach. targets antibodies, a highlight to for Kong want and have going in-house nice I So bi-specific multiple create way still this candidate that at

Zegbeh Jallah

just know last seeing Thank here can about we then well. virtual, We yours presentations as you. AACR. so wanted if to know And some question that do be anticipate will

Sanjay Shukla

Yes.

next Right we presented prioritizing to yet we are we online but course, April, AACR, an away. of abstracts haven't from be know electronic you poster let have gotten fall. Should so more anything rescheduled annual clinical-level details in and data being the poster we're we'll to suspect planning, I So they to this right be know asked certainly online we is month. clinical yet. at But or don't display now, think meeting, their for which present

Zegbeh Jallah

you. Thank

Operator

question And H.C. you. Thank next from comes Pantginis Wainwright. Joe our with

Joseph Pantginis

and Hi for taking Thanks and your hope question. Sanjay you I families the are Jill. well.

I The one I wanted to is COVID, to sites part already you and gave impacting clinical wanted patients being which potential it's regard think potentially you if the you update unfortunate. update from heard start about, Just to obviously dosed. those with said certainly ask correctly, also the impacts with I

sense regimens? I not wanted patients to might – some there about guess are their get a I so So full that get

to it looks still this, know because to sure how regimens plan the overall of if it's cetera. but early, can I'm though answer is statistical the et to even impacted, it out, the impact trying study you being of apply data FDA are might a the And how figure don't lot the you or

Sanjay Shukla

That’s right.

who see those how So an folks. these excellent want have handle perhaps to it's enrolled, I to already We're going how are the patients to think PIs question.

case have and in be for relative would You to delaying that were off-schedule. would delayed be could it be weeks, which that monthly individuals some dose it two period four a could there a

is FDA are understanding sponsors this lot is acknowledging the that a dealing think and of that with. I that something

At Maybe the patient five have a time, the already may towards doses. end. same gotten also you they've

useful get We have to to that determine, is them sixth for it dose.

So it's the really dependent going on to the be PI patient. and

a in. them centers have bit number more coming that continue, want We of to little about want patients to be back the a but careful themselves

Flip some back side, have might concerns about also in. patients have that we some coming

see enrolled to who off-schedule, a schedule. slightly we're that to So them this get is patients been dose. something on have but could to some think I you that skipped look could of monitor, have kind expect that to a we'll have have may is Others can the going back and potentially then dose previously

I have our based even, drug. even expect haven't they our effects patients still would with PK six to five weeks been want if on to a we see highlight of we or dosed And here that for say drug. PK I pretty long-acting the PD

that at out have here that delays working closely of are, our time. helping period. we long with we're these this this us determine But during again it's kind how So centers to something

Joseph Pantginis

Thanks Kong. forward. announcement recent that moving out to Hong then Sure. the that. moving Very And of the Totally understandable. just exciting bi-specific for program's

all to you So anti-CDX more makes on pretty to Or regard sorry, be checkpoint are classical at things? options looking you components? Are point? novel the not target of looking of you much just to or also curious, of might what side other Are – at like targeting this clinically, what sense the sort open with types I'm just the scientifically bi-specific?

Sanjay Shukla

evidence is thing is think known literature for, the the or pathway what cancer things are with we integrin indicates. diseases. already and like targeted think CCRX. that the been have to at here And look for and These example, or neuropilin-X have important the co-locate I the other inflammatory pathways to pathway what I mined plexin and important

I not those bi-specific only both the think a a the we modulate neuropilin but is platform advantage have co-located to also potential with once, we have other receptors. pathways at of pathway, now some

that create program. at lead our this inflammation, this candidates are antibody now still cancer can IND that to another through broadly more avenue So ability platform and think potentially there's looking is I a to bi-specific something but from we

Joseph Pantginis

Sure, sure.

so Jill don't prepared You mentioned you question in a if comments, for mind. then that housekeeping your maybe And appreciate I that.

to regard million for that. amortize to the with going that a see there how and wanted immediately $X Just to to payment, be get a sense. to wanted Or some? you'll accounting be upfront going you're chunk Is just recognize then

Jill Broadfoot

are out will for under some carving licensing we couple a There Yes. the of that. be obligations that agreement revenue

starting are and done. to have analysis just we'll of We our that have evaluation

those I license would obligations say So deferred be how recognized fulfilled, can't say portion. recognized. much should assigned the will be are much exactly of until the how it probably will but majority be majority and be will to I A

Joseph Pantginis

Understood.

stay Thank guys, and well. you, Okay.

Jill Broadfoot

Thank Okay. you.

Operator

will from Oppenheimer. you. And Hartaj question Thank next with Singh our come

Hartaj Singh

and the commentary you glad and during to for Thank update I'm Great. these is times. the hear everybody safe

is just actual with up or of the you're in cohorts? with the at sort get you that gave for cohort – of as are cohort at terms Just that rough to of – a thanks sort color second where lot third cohort had Joe's questions. a One few you you of What so questions, Are a – idea? dosing Sanjay. so are

Sanjay Shukla

study We in our – the complete our to these are so final enrollment. final are really we're in looking that patients

Hartaj Singh

Got it.

have of – great kind some I mean to steroid tapered, of tapering that kg a point. that looking prednisone, these of you How know patients the process. a try I done, really their going five if down which probably some I is, that demonstrate think through one day was question I of think you already other initial tapering, of surrogate things these them end steroids were would that's some of per the are to can milligrams that? The be handle getting who were patients that to

through this handled would you're this – be sort how So through as going of time? that

Sanjay Shukla

Yes.

a as So I XX first reminder, think from the kind in of days being the dosed. occurs tapering,

attempting So to the in milligrams down were trial. everyone we to get five weeks first of the eight

that if on a can schedule, So they've certainly, that occur if dose. still anyone's taper received

decision want the shortness around re-dosed XXXX, that's made think the important has if and monitoring I their with cough don't investigator be of is to or where thing clinically think dose of have breath. here you another I a

we So it's have, two Cough basically still is much titration validated Dyspnea the Leicester on Index that a assessment using real-world and Index. those done Transitional based the very symptom indexes and

that's occur. going to still So

where get The for trial. the the active is they are, the eight, Once The of suppose, that's they key in. here where much in week earlier real-world and I taper. seven, you titration component are really steroid in component our kicks trial, week that's past

that's So going occur. to still

want the hope PIs centers. think going here of this during at dosing working here determine be is thing of to our manage what is the to some a I important – to short-term they drug with how our we of pause

Hartaj Singh

looking on then Got And was I ClinicalTrials.gov. it.

any or I one or get think that flex protocol? add where that into to of shutdown patients patients this centers you patients additional are argument, to for three patients Do like maybe or less of roughly there's some say recruit just not a flex of in protocol, kind centers then you of believe into could any still recruiting. or sort you built sake two that study, XX could on let's have center. per whereby, want the I the and can you states two so centers XX built have

Sanjay Shukla

question. Good Sure.

So the of at a patient recruitment without centers. our we cap protocol wrote any

that's right are our actually to because several advantage working centers moving there now think are still forward. that I

that our of patients. enrollment. was enroll It there only we cap two, centers not four any competitive a is three, could So at

different up allow some delays some study, have XX to weather if going get patients of centers our see the regions us sense are incidence into the allows this this hopefully to, some of here to, ability centers here. us of in the level for that COVID-XX the We're a impacts. slack a to the is if longer-term I So XX of different delay, you and trying will, pick think even

Hartaj Singh

on Yes. No. one Sanjay, XX the that. That far from getting you just that how update Is – helps a patients? quick away lot. from And then, all

Sanjay Shukla

from How we enrollment? completing far are

Hartaj Singh

Yes.

Sanjay Shukla

we're here, be enrolled. a to mean I that in the really handful Yes. of need stages final patients still

say complete the that once all really anticipate were I centers, The I at stages we before approaching trial more completing in long of this just more would would how able final we'll is of see little delay. I get believe crisis issue hitting a impacts we be here So enrollment our started to a the fairly that of this enrollment going health bit short time. really amount of actively And be, let's the operations. again to

Hartaj Singh

question Yes. is guidance FDA to Last this, our that on put has already companies. which

fairly it's that clinical I thin think are document mean I on ongoing. – trials a

dose, you get longer, is would to to study Aside patients get said, feel even patients into happen, flexibility be with enough from or there some like want from miss statistical few to centers, if readout these a let's might back, pushed et or two even sort assessment, comfortable insight? validity things go good cetera. power you But still in there the and, protocol, safety gets whereby able enough your being say, back the gets a one a built pushed you if it of maybe

Sanjay Shukla

enough making was and we look a on are we multiple trial, these ascending we certainly adequate tolerability If than testing mean a it XX patients. or here. have and safety-only from patients doses to have is have safety make patients more just not and whether a view and a safe in assessment, tolerated I start really to perspective, to safety

necessarily this had so an out III a we significance. activity for statistical I think it's level to not regards With Phase signal, built that powered

However, sparing, activity at I in of the PET symptom around of then our to at function end testing scans detect points trial, trends our and pulmonary be looking key believe also some as we'll able steroid well. well, looking as still scores and efficacy

we'll to not a and activity think, still assess time, see So things these able determine I that or over here. are whether be signal all we of

it beginning I of would think occurred the detrimental. this lot had a more trial, towards the be

as still get complete that once said we up the point. to able being feel we good enrollment here, to I finish As and calls make about we trying to think we're actually readouts here, these and

Hartaj Singh

already Yes. No. this. Scott is Gottlieb with about lot call in intensive our work a companies That and makes weeks sense. said on how a ago on he to to of of had discussions assist We couple FDA

So assume and patients I under that be also. COVID-XX mentioned these will them question you the with will that – are the things that be what working them each on will on – is with of had Last suffering ARDS. that

I that remember that do models thinking to some myself go down that to animal seemed you had path.

next but a in the that would was to this Would two-center out of know to Thank this again. see If give up and you have be with What it up Or work steps? one regulators as idea forward? sort regards, more? steps would the of some be were you to trial? want do you, you you thumbs – you if need expectations, a sort these how kind coming doing? if Would were we any I we don't or other to build see of companies or of could are progress NIH unnecessarily next

Sanjay Shukla

Sure. And has of listen this first into is here. I to there, think early. important to to get the point preliminary important the what It say was to It's dialogue. it some FDA

ARDS is demonstrate lung I same you models, inflammatory early that think that case cytokines, we of acute the evidence see down-regulate and in the in cytokines out many the these injury have of in that of compelling, the some pointed you damage of some that can we some of some around reports. involved things are

things good all we data Given have have Phase the and a to I from are an IND, that data existing fact these the good fact working safety margin, advantage. also we our a that safety

drug in looking FDA. had some a we that of from In to we do sorts kind get compassionate-type we're something if feedback supply are adequate things to these wanted that the addition, of model,

start they're to a whether think talk that bit a case-control want As XX, Typically, then and move other to far in the to looking efficacy. larger some what first that. XX, determining them, I as doing, are look for of into demonstrate companies, type or if signal design not just it's here XX really study of to you you patients nature, early a of little at about

from there, better I it's engaged it's exploratory, So a we And certainly that say pending is steps. some idea early. now, I already have. of next have, said, as evidence feedback There just think I would regulator. right And formally a the have we rationale I'll the

Hartaj Singh

Thank the questions. Great. you for all

Operator

I’m Thank you. further turn call I showing for no this further remarks. to now will questions at any management Speakers, over back the time.

Sanjay Shukla

everyone, questions interest from analysts. thanks, the your for Well, all and

providing thank you said, support. we I the to updates future, near for As your look forward in and

Operator

Ladies and for call. participation. concludes your you Thank today's this conference gentlemen,

You wonderful may have a disconnect, day. now and

aTyr Pharma (ATYR) 26 Mar 202019 Q4 Earnings call transcript