LIFE - Earnings call transcript Q3 2018

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Operator

Good afternoon, ladies and gentlemen, and welcome to the aTyr Pharma Third Quarter 2018 Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will be given at that time. [Operator Instructions].

As a reminder to our audience, this conference is being recorded for replay purposes. pleasure Chief the Financial my Jill over now aTyr's Broadfoot, Officer. is to conference hand to It Ms. Broadfoot, you may begin.

Jill Broadfoot

operating aTyr's Thank you, joining quarter discuss for thank And corporate XXXX third Telsey. Good us afternoon, today everyone. results update. and you to

to Sanjay of by Sanjay an then it results the ATYRXXXX. open our I joined on president and strategy before provide our back financial Dr. will are the and Shukla, handing to to We the question-and-answer update corporate today CEO. will clinical Sanjay it up development review session.

statements will forward-looking call Except information, statements as future forward-looking obligation change. circumstances. to of required these these on Factors date of reports release like after begin, I involve should the made Act such those and Reform over from most and law, remind statement SEC we in disclaimer to company's company's for risks differ in recent circumstances or disclaims may Safe placed call as the today statements Risk on Before and can the on see forward-looking be underlying except uncertainties of in to on and not events statements provisions results speak XX-K filings statements management turn well Sanjay. historical aTyr included would questions any as Private cause annual the they which statements update issued and to XXXX. made the the Securities forward-looking as the of Form only everyone conference the this press the are I These facts, the Litigation to that facts on XX-Q. reliance close responses report Form actual quarterly the our materially and of to market by Undue as under Pharma statements, by now forward-looking Please statements. that earnings reflect forward-looking Harbor are

Sanjay Shukla

good afternoon, Thank Jill. everyone. you, And

in progression Lung Culver, disease, educational sarcoidosis of Association Interstitial pulmonary this clinical patients is From Sarcoidosis clinical our of in hosted specific to highlighted lung pulmonary previous year. of morbidity Disorders announcing that within in Xb/Xa end upcoming for In milestones, the Advisory Clinic. Other the study. the San Phase at World the Board recall in Annual trial further site involved the Meeting Foundation of Disease XXXX Granulomatous our this we immune for the the and inflammatory the at the Dr. clinical disease announced two initiating and quarter to down-regulate program XXXX of activity fourth the disease webinar we the a featuring the milestones. position Sarcoidosis of CHEST Culver an modulating earnings you in-cell potential preventing the in Director we October, and President-elect pulmonary today this If say trial call, to our selection both patients the upcoming and our key for population, interstitial has sarcoidosis we’re by Research. of of also discuss in Cleveland We disease. I'm as Chair pleased of Antonio, Dan of cells indication believe Scientific ATYRXXXX for the protocol

impact on During and webinar, provided on Dr. sarcoidosis education Culver the pulmonary disease its patients.

study. have developed the and We and our while appreciated upcoming protocol his from for in sarcoidosis have have benefited Culver's expertise Dr. feedback pulmonary experience we

can nodes also patients. categories skin, are of Within and eyes, three organs results sarcoidosis cells a clump the in in pattern by webinar, described Dr. immune The a granulomas. liver; of that of involves multi-system have disease lung the whereabout other there this the XX% to will educational disease As is system sarcoidosis the a that involved. of Culver patients be called lymph population activation is XX% a in involvement,

progression clinicians, patients, Estimates this form sarcoidosis. primary disease difficult with We to The this have with to own, of for XXX,XXX progressive organ take active significant of patients have what Based whom you unremitting ranges is information last remaining treatment and XX% patients a steroids is chronic we are we is patients on where resolve approximately patients Americans sarcoidosis. of And prevalence believe complications live from granulomas between of Approximately number see and no the chronic pulmonary estimate treatment. vary, the so learned for second XX%. impairment. first, pulmonary fibrosis long-term for of its that XX% as approximately are expert inflammation there present where Steroids will XX% those the of to a which XX% the on group. formation.

study noted they immune cells and Dan their need say high. safety of because is of concept plan that generally patients sarcoidosis. inpatient XXXX many presentation, quickly, of far clinicians the of steroid-sparing effect, The for treatment steroids treatment designed multiple are like pulmonary quarter. tolerability, work evaluate Xb/Xa too Patients dose and in and and with this cost targets pulmonary multiple-ascending proof but with later placebo-controlled toxicity his XXXX. pathobiology a in immunogenicity tolerable has been sarcoidosis to initiate of to Phase of We first doses As the study in the effective involvement pharmokinetic

endpoints preliminary evaluate potential In efficacy well-established to addition, and assess biomarkers to of we XXXX. intend further clinical

recently to and able key be hard our protocol, Our starting of clinical Phase deliver this to execute our finalize with our filed milestones, the upon team Xb/Xa initiate the believe very I trial. trial. We will objectives and working with on team clinical been initiation IND our entire has FDA, this our

of But is protocol. to approval. of subject highlight and features design the our course the some like proposed I'd to protocol regulatory review Of

follow-up trial. doses, four-weeks X:X cohort, XX XXXX administered at of will patients planned cohorts. to the to enrolled visit US. are infusion. to is paper steroid a of every be levels The are randomized, last total for in An in of X each The submission to all and up our Study placebo. will of X XX day centers Within For before XXXX the of with patients a be infusion of prednisolone study milligrams the to be consist a milligrams XX proposed day patients via or either From for proposed drug of kilogram. XX XX. X a multiple-dose in day prednisolone, per completed a X, three-staggered dosing up will the be milligrams XX of dose to our after target important study IV four-weeks component the six starting submission dose

while for believe tapering treatment steroid worsening will to higher to Patients of evaluating patients these of the rescue By who regimen receive following unable real-world develop potential doses the may the adhere this are dependency to the access of XXXX or evaluate for ability able be and X steroid symptoms manner, agent. will indicated. to to or sub-therapeutic remainder we with as the trial in of their the be milligram receiving XXXX steroid-sparing placebo. be dose acute of an maintain we steroids a We clinically

For interleukin-X our patients or analysis of disease. we efficacy by by cell as changes submission, disease activity FDG-PET such related the of in to quality serum receptor enzyme health of that cutaneous we energy of finally vital life forced enroll those blood, by peripheral imaging, subset time preliminary XXXX immune and assessed skills, skin of capacity state with plan and explore biomarkers lesions for levels, in over lung FVC, also evaluating function assessed angiotensins-converting

in field been they've approach. our has dozen design protocol reviewed by over a the and endorsed experts Our

and changes We Our patients observe allow robust to opportunity I preclinical in for enough potentially treatment see provide future goal endpoints, including other development in particular, of with to interstitial chronic data the Phase of over reduction supports XXXX period pneumonitis arthritis rheumatic our as XXXX, sclerosis ILD. connective profile believe in systemic steroid disease-associated clinical not and on pulmonary also discussions ILDs, is sarcoidosis. lung disease dependency. the a and our we experts, to hypersensitivity utility meaningful and in evaluate ATYRXXXX us such with only of also immunogenicity tissue potential Based duration safety but clinically indications, ILD,

a discuss our to financials, to pass talk Before I Jill about our to it to of want activities. I research some take moment

broaden are initiating and at call, academic activity further XXXX. studies last to and earnings collaborative our first biomarkers translational test in conducting We're evaluate new range our indicated institutions. we to of the for As well-known doing potential so actively research of

XXXX explore potential other to want understanding our the we advance role, addition, finally, in and of which to settings interactions could additional of NRP-X the And in to and role biological XXXX which In immune therapeutic indications. plays responses. lead of a interaction regulation neuropilin-X

near some these of on will the in efforts update We future. status the of you

review our to resources. Financial corporate Our our focused on critically results. and to same turn Officer, clinical with over mission our the it remains that With of we overall Chief that, I'd to like science Broadfoot providing Jill are our current translation strategy financial and

Jill Broadfoot

three to you, The ATYRXXXX consulting primarily for million and in and million were $X.X the Sanjay. the XXXX. and and nine three million periods and million development related the with ending month Research $XX and September nine and million three and $X.X a to decreases General $X.X the the decrease and XX, for along and ending the manufacturing in decrease XX, costs, to personnel-related reduction The nine clinical completion September related month periods fees expenses in periods nine were three month of month were XX, million XXXX. to September personnel-related professional and September $X.X expenses $XX.X Thank ATYRXXXX compared $XX.X costs. XXXX $XX.X ending expenses ending fees. XXXX periods million and XX, administrative were related studies XXXX compared primarily million for and for

in of we $XX and burning As year net quarter quarter we our of $X entered million per approximately per QX last earnings 'XX. to payments, 'XX year QX in exit burning the million on call, debt plan mentioned our this approximately

During final terminated the month. $X.X which Research collaboration of to which third our Scripps payment burn had a million Institute included under cash this our quarter we

very bur payment, in expectations our such pleased reduction and in with Excluding operating line our our I'm with expenses. cash is

we $XX XXXX As XX, of September million and cash investments. in equivalents had cash,

September million Our approximately XX, net of cash $XX.X XXXX. position was as

net $XX.X approximately debt million from in our Our cash includes total position facility. loan

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

Sanjay Shukla

Thank ATYRXXXX. and spent you, achieving later focused Thanks, trials XXXX patients time, year. At on our prepare scientific proof initiating of trial goal will to everyone. questions. this development pulmonary our Jill. take for forward of to the Jill your meaningful our of concept sarcoidosis clinical be I to building Phase XXXX look We right happy foundation in this directing Xb/Xa with to efforts the We and

Operator

our And question line come of Instructions] from [Operator first BMO with the Luchini Markets. Capital will Matthew

Your open. line is

Stephen Marshall

Stephen market a indications, to and why is kind is This that? get of on Marshall choice opportunity XXXX a for was possible the Matthew. more those little color for guys. I is on just Hi, future hoping what good

Sanjay Shukla

good Stephen, So, question.

utility have could So previously we drug outlined we diseases. a interstitial have number that of in our thought lung

we sarcoidosis potentially experts is as early most next lung you more And proof in and interstitial to have focus to on next a But this and these our common interstitial on. of think in share tissue lung diseases grade remember trial we would that have CHP these really and clearly connected pathobiology If a we pro-inflammatory concept first and eventually Ultimately targeted focus fibrotic diseases. indications. those guided in be lead diseases pulmonary follow-on the that decided the this cells those progression pro-inflammatory such CHP. to of have other conditions resources disease, as sarcoidosis fibrotic probably efficient that us pattern

those to are immunopathology of market ILD I springboard of When you in we within I said, able across indications, scleroderma. example and conditions be conditions. establishing because with segmented all are for share CTD other by these RA as a all size, mean proof think into common this concept very I these that about quickly study they think will

when about we’re world. So that’s kind still the those of experts. is But with numbers, emerging you a those CHP this working throughout on condition talk

two-thirds of incidents you than depending You market the frankly the lung all XXX,XXX, and XXX,XXX have them the pulmonary where similar IPF. on also each sarcoidosis. in can the see when disease about more for that of rates think sort But and of I I think subgroups start of of patients of represents interstitial world to the outside prevalence. see are spectrum patients similar this you When opportunity,

IPF think population, the those fence double this multibillion-dollars So are it in of look -- multibillion-dollar one-third I represents the sales where with generating many I ways of they that. at think if side on ILD you of probably of drugs

concept. million we $X opportunity So to billion my at to near -- more there's in to is look pro-inflammatory guess after billion $X of those million somewhere plan lung establish to proof interstitial $X we diseases $X this of that

Operator

Blair. William comes next Xu Katherine of Our the question from with line

open. line Your is

Unidentified Analyst

Hey, into talk for to question. see in study when where Thanks you're Sanjay, [Roland] sarcoidosis on see some indications 'XX? other XQ the And clinic? Jill and team. about the This you my pulmonary hoping for is might Katherine. Could pushing you taking

Sanjay Shukla

a to activity. clinical markers. What that a patients can that particular important sign is trial. have the of in so a us read experts demonstrate their believable box here of takeaway and want in But that to safety have would check to trial. steroid Sure, clinical from this clinical see establish demonstrate is opportunity in real I tolerability this eyes think burden area our the response dose we later if and and want we with done the really and activity want most I really told as to we've the make out maintain dependency year element we we Yes, Phase some one continue is trend these to that important this with those we

We also clinical our to have trial ways activity. other in at look

have strong FVC. trials that's We looking function sarcoidosis then with is at looking change PET being at with very and scans. endpoint a This much imaging pulmonary also and experts are in readily something with we test more used

X to know cohorts dependent see population guys a read you and tracking two of two recruitment to But towards is going we're first to early I'd us I'll how next the That's those going for those those on of what like All of you X end endpoints back is to going want to to come around that recruit be the faster, to the three milligram XXXX. get our I'm probably we're minimum activity probably let of the maybe out be at believe we really some it things next QX able can and of able to to that. If have these may what on see, -- we to in exactly pay of the to first whole half back in but we going data year. year attention. out. are you to to endpoints most be folks read But sort milligram trial

Operator

the comes Joel with [Operator Instructions] Beatty question next Our line Citi. of from

is line open. Your

Joel Beatty

is question. follow-up last a to This

those stage expect in pick-up improvement areas less think the clinical clinical trials. you be those for thoughts which this And are study the you those noise endpoints in and those you You three guess as of to the to clear of in of kind early-stage of any And of can you talked are later about that that there share different activities characteristics maybe might terms endpoints could important are signal in endpoints trial. you one? smaller a some have you the I that on important looking such different are most would

Sanjay Shukla

data their that's variability. three and with cannot keep are should I’ve steroid-sparing is, that’s Yes, data with agree sign per of that, the in guidance Joel, we on to dose mind the able be of to the of X a you'll our clinical months the here on and is And in question. most we've If of really within activity of think that all nearly believable the most great and aggressive gone Experts of milligrams based in how mind, the experts patients importance kind there to and of way sort inability order two prednisone. least stressed that has the you I that see from what out Typically shown the literature. pretty about the amount -- maintained it. think approach

steroids the kind able their and idea testing receive overall and and is to knocking here patients So are better or how the then see expect the lot dependency amount we XXXX, the sort see we at do that steroid to presumably of dose to can burden their of The dose down they whether of of these not. maintain look to these folks we’re symptoms a steroid placebo. patients essentially disease and compared manage sort that and

You of this endpoint sort that’s are there, and and activity also to at. look also inflammation sort I secondary of this important, of efficacy I disease space that FDG-PET peripheral perivascular looks we endpoint, imaging think much want sort impacting? is really at how look at inflammation of think by imaging to sort

be But that Lastly look see to to FVC there. have try have that’s I probably if at you endpoint. to most able think improvement variable and we your

able low be us to as So I of out this read think in we are of important dose If really increase able we lot importance that to these to we order finding of our do see importance a with we for steroids. trend place doses a in that’s in a patients going a as trial. particular we if being sort manage of

Operator

Thank of Joe Aguilera a Advisors question we with And from have you. Telos the Limited. line

line Your is open.

Unidentified Analyst

And data, some potential forward for are XXXX? maybe it’s at going here. you after this us Sanjay, you looking data, color? What's of a partnership Joe the the give can how before the

Sanjay Shukla

have one Joe, around se. we to partnerships things with robust towards attractive really I per I think guide a opportunities. I mean be of created the state, look any an as of we don’t will the program opportunistic sort those certainly of translational

We tight. we submitted believe we've getting this protocol the IND are and on started. done are that, program nice excited focused and really about the getting We

generate when really this time, our with I and more around and to look will this of drug. per includes any will value there we partner which ways we if regard guide a But in IP I partnership. always we have that think and don't can at se

Operator

turn like Shukla call Q&A back Dr. that session for ends our to remarks. final And his would I for the today. to

Sanjay Shukla

very in updates the very look your months to attention time ahead. for Thanks everyone and We providing you Thank much. much. forward Thanks today.

Operator

thank a conference. disconnect. may wonderful concludes program This today's that gentlemen, in we day. all ladies participating you Have with the and and And you for

aTyr Pharma (ATYR) 13 Nov 182018 Q3 Earnings call transcript