LIFE - Earnings call transcript Q2 2019

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Operator

Good afternoon, ladies and gentlemen, and welcome to the aTyr Pharma Second Quarter 2019 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 conference call, this conference is being recorded for replay purposes.

pleasure aTyr's the Chief my to call now Broadfoot, Jill Financial is to conference hand over It Officer. Ms. Broadfoot, you may begin.

Jill Broadfoot

and to quarter Thank joining corporate Valarie, good Thank everyone. you, you update. us today operating discuss XXXX second aTyr's results and afternoon, for

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

Securities we statements actual everyone XXXX. conference facts, Act Private the from this I Litigation statements differ Reform involve statements. responses and Before the begin, cause except historical can Safe on in These Harbor would questions call like are and results remind of management that to those uncertainties materially to that of of to forward-looking forward-looking risks provision such statements statements the by made for under

only these to as Please events information, reliance required forward-looking by on obligation well statements, forward-looking to see the Form quarterly they on this and circumstances. Except change. any Form and SEC of as made statements as the report the in disclaims recent update are law, our the placed facts which reflect as speak or may date as annual be Undue the filings Pharma reports these circumstances statements forward-looking issued release underlying future aTyr company's most and factors forward-looking XX-Q. on morning included company's should in risk press not XX-K statement and on disclaimer

the turn call now will over to I Sanjay.

Sanjay Shukla

you new quarter following; conference trial for Good we to KOL Scientific term. the call. results Daniel our position our Directors us our Culver the ATYRXXXX, our afternoon review a the for recent Advisor Cleveland joining a of Jill. clinical for featuring of outlook you, Board of and discuss Clinic, current sarcoidosis near of Xb/Xa recap and a everyone over on Today, wish to appointment additions webinar our finally and update Phase of an the thank on Thank financial Dr. second recent and

our mediated that leveraging proprietary develop of immune target currently unique a biology medications diseases. class new We’re to

is therapeutic lead interstitial for XXXX, candidate, or being lung developed Our diseases ILDs.

indication sarcoidosis, initial more pulmonary inflammatory of the Our forms is of one ILD.

by the lead in Pulmonary of and patients to can the diminish is these current approximately sarcoidosis function. are being if progressive untreated characterized despite approximately alone, of There inflammation left U.S. irreversible standard care XX% with disease that scarring patients treated in pulmonary lung corticosteroids. XXX,XXX lungs sarcoidosis the experience

are steroids many are While beneficial effects. for significant some refractory side and patients, experience or complications

being Phase patients. is sarcoidosis randomized, in dose clinical double-blind, in XXXX Xb/Xa a trial currently pulmonary multiple-ascending placebo-controlled evaluated

of pathway have XXXX’s demonstrating mechanism optimism XXXX This numerous us data distinctive development compiled we study. continued preclinical strong through from a studies of for inflammation. robust animal models unique We effectively translational a combined our as and that research, study, in of provided targets rationale Phase in X gives significant a data body advance action safety this and with

I enrollment that pace. update status trial; on small our of indicated with would I call, give slow initial sites last of the On slightly with number an active a the

increase of observing all enrollment activated, are our clinical in sites we planned XX However, that are an rate. now our

the interest trial. additional American from At conference, pulmonologists participated received Thoracic the that significant recent we Society in

the XXXX end we and in the participation in of evaluating potential for blinded currently study expect be findings focusing by from interim these their We our study. potential the on sites where data this U.S. EU We’re from will both initial in still safety data.

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advancement further call. next our clinical of provide our on will during We updates the trial

in interested and significant in believe value remain our our trial. the leading area of is we ILDs pulmonary proposition very Overall, experts

focused We is with the on ILDs all inflammatory least IPF, or pulmonary ILD. forms which exception of idiopathic are the fibrosis, of

there’s we opportunity company a Positive represent tissue $X of competition results connective include ILDs be little ILDs and for trial our to us and pipeline area as confidence and ILDs. market would believe transformational from these a unique to chronic this would billion our Inflammatory disease further to pneumonitis such opportunity. where give $X conditions billion other expand represent hypersensitivity

current we the the successful life Dr. persistent unmet have of We featuring sarcoidosis the many seriousness landscape. and diminished Culver’s treatment the quality disease, with the need Clinic. recently discussed of held of on medical Cleveland associated webinar of presentation Culver including Dr. sarcoidosis reiterated Daniel the a themes the

XXXX of a with new believes used is be favorable a if therapy. potentially could Culver more that first-line for profile. is clear as action therapies approved, There onset need a safety it and Dr. faster

webcast very replay Investors under section the and Events slides A from our webinar on informative be site, Web found accompanying www.atyrpharma.com. this Presentations & can our of tab

our unmet operational unique this trial in of success a clinical area pathway As forming in translational need XXXX’s of by, we one, demonstrating discussed designed we’ve of studies inflammation. effectively action and that distinctive medical call, for a high number the series on mechanism minimize risk believe targets

leading to demonstrating tolerability safety pathology of and in community. Number clearly disease; and finally, trial address with volunteer initial trial. in two, the three, targeting of sarcoidosis our support the healthy pulmonary Number pulmonologists with this the the X Phase clinical designing XXXX immune

and working to with experiences other backgrounds. for we release welcomed details and to Lucas’ Gross’ look in July Svetlana Xst them. refer forward additions Dr. Jane to recently new extensive Their and about Please to and Board executives Dr. biopharmaceutical Turning combined Gross strengthens press two to our full Board and the and Lucas. now our We seasoned Dr. commercial our Board; important research development business company. clinical academic,

leader field. School signaling Scientific joined with leading pathways. consult and welcome researcher in opportunity Dr. a We ongoing the Hospital and We co-receptor as also work that to the Medical related announced to Boston thought on David on Briscoe, emerging development Children's Briscoe, a the therapeutics has NRP-X company at aTyr Advisor Neuropilin-X Harvard with this a of based the or Dr. immunobiology

that Inaugural discuss in As together reminder, co-receptor. of we therapeutics NRP-X researchers the development a to bought key Meeting the relating most April, hosted to discoveries Summit at the targeted directed recent NRP-X an

previously on demonstrated Summit, immune attractive disorders range as Briscoe earlier as an other macrophages this and NRP-X that a AACR attendance the medical significant unmet with needs. their in in by Dr. NRP-X NRP-X year at broad by XXXX of implicated activity. other impacts the acting down-regulating cells target We as immune At well experts

ability therapeutics to of in is this expands inflammation. with such high-value pathways as specific a develop developing team monoclonal directed cancer selectively currently receptor. research to areas, at novel modulate number in approach associated dramatically order our NRP-X Our antibodies and This

U.S. with a our to R&D program and and to we our as support mature. We biology, To establish first-generation antibodies internally on international efforts externally validate models position patents the lead we of protect further to now that providing we our our monoclonal recently are test as well in further collaborators filed scientific and of in progress NRP-X in developed initial leadership during look antibodies disease. working these as to programs updates forward and vitro animal these

lead company the In our ATYRXXXX. momentum with program is summary, significant generating

base NRP-X selectively receptor. to of modulate continue our antibody We this the through approaches pipeline development advance monoclonal to

our of medical underserved Board of new unmet biology to help expertise we With and further time two and internal long-term value populations while creating area for potential Scientific new leading shareholders. the the our feel believe we explore at significant Advisor, unique address a needs. a we this opportunity enhanced serious and have members to addition I same have patient

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

Jill Broadfoot

Thank you, Sanjay.

preclinical time CSL first in we Behring, agreement product our company, synthetases of a or derived development from have pipeline. collaboration. from a recognized in collaboration and research up we March research CSL, for XXXX, with candidates tRNA four from the history For to revenue of the option In the entered our

and the received development collaboration, all research funding totaling of and May CSL we XXXX. Under phase of activities XXX,XXX first in the funds

We four option up are synthetase CSL. synthetase total of of in to fees by programs total XX million a receive advanced million up X.XX a opportunity also have all if per an program to to

And if this research each CSL, that for emerges candidate rights have advanced negotiate IND a they option license by such collaboration. will from to programs are worldwide an to

months As XXXX, XXX,XXX ended of under agreement. June CSL of the the three XX, the we collaboration a recognized XX,XXX revenue for result,

also programs prioritization I’m the XXXX. report happy corporate and from to that continued to announced we savings cost realize restructuring May in have

is continue also which We to find to more reflected operate efficiently results. in XXXX ways our

million loss million and periods for net and XX June XXXX months three million per respectively. and XX.X compared reduction the approximately same in X.X XX.X expenses was respectively, million a million, represents of This in to ended Our XXXX, for XX, X.X quarter. six the

million as December with cash quarter the equivalents investments XXXX. and compared XX.X cash, million We in ended to XX, XX.X of

gross a Our led Federated at million registered direct the cash includes through X end in raised investment quarter by proceeds Kaufmann.

XX, of cash equity, was our the only For million. burn, ended June six XXXX, net debt months $XX and

the at we now of ending XX million to guidance of of a equity. lower projecting debt and total million, year burn range XX cash the For are XXXX, our previous end net

to debt long-term from June year-end XXXX decreased at XX, Our million XX million XX.X XXXX. as of

the fully We current XXXX. Xb/Xa sufficient November We trial. cash gives equity and our repaid revenue, our cost have by to target combination Phase are proceeds to measures comfortably believe saving clinical complete loans on us of

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

Sanjay Shukla

and look happy providing appreciate At forward We and questions. Jill. Thanks, be this interest support to further in to future. continued Jill the will your I take and your updates time,

Operator

Thank you. [Operator Instructions].

comes Our Citi. from of Beatty first Joel question

open. is line Your

Shawn Egan

Joel. you number passed an whether provide Phase first enrolled calling to Thank Are Hi, guys. my and Egan able or for the yet? study for This dose cohort is the Xb/Xa has update taking in of questions. patients on the Shawn you not actual

Sanjay Shukla

Shawn. Hi, Sure. the for Thanks question.

be that we’re that’s now I need once providing With information play we outline se. by looking to of but play will safety around do track of that of not that some dependent particular all that the per I results we to that in really review, enroll here, potential this a say we’re is and on analysis. end of still final running. season to that that DSMB the and dose escalations sort those come We’re number centers you’re will patients numbers at of that for interim the on up of year. on the sort going XX asking will say have a

that updates call. next more providing earnings around be I’ll at So the

Shawn Egan

more know it important Phase endpoint do I understood. it build as Xb/Xa a into past you you you as potentially is pivotal endpoint? could you the Do the a view that or study. Okay, that potential how steroids discussed bearing endpoint they believe commercial the in

Sanjay Shukla

believe them think meaningful clinically the endpoint perhaps most activity to very and this focus here. on that that the that would really that clinicians certainly endpoint make heard is I of innovative it’s something we’ve the from sort chosen a Well, we of drug. It

the real endpoint As amenable things starting patients, least endpoint. imaging very burden present that. Traditionally scans that toxicity solely you no that becoming at see they’re current at it’s approved people where that have as to so like the around endpoint, in as to been being I to and will in here, used these much the a say now hard see drugs as PET I endpoints steroids looking predict relative more included think sarcoidosis. agencies SVC such composite are are in But diseases

important the we need patients. course study. need that a the toxicity But endpoint out next so better patients whether with it’s these how part secondary it, steroids because for We they of such of down efficacy therapies sign endpoint treated an are on regulators it the So need primary sit like how or a much a would in Culver of see create I we the it’s pointed Dr. as think and activity. to themselves these

Shawn Egan

question status? this it mentioned see sense. elevate that therapy. that would Thank criteria Yes, makes a that potentially about indicated last of my And kind is, the you’ve of or with then front-line spoken being benefit you, do of some Maybe that talk have to Sanjay. doctors what you level what think they you

Sanjay Shukla

I that experts are and think represent boxes more Culver corticosteroids care less think these thus not to of replace that Dr. patients, also in at And with a toxic the is looking lot I checks has a highlighted two the less far. those fast onset our therapy that a Yes, toxic or standard drug or as reaction. all

like we it when about steroids downstream our could prevent that as potential we of of kind therapy, replace we think having progression I that really sort mechanism. of and first-line fibrosis, a So drug think

we X So I of take our we that’s it would benefit. think where see In folks look trial to milligrams. down course to

if the even of say XX, steroid of at XX, are burden. that difference. came low they are end to taper doing significant in week some some from down XX And have amount perhaps X, them a pulmonologists go would even I incorporated should from discretion So our protocol we we fairly that XX, to that zero. they if patients significant tweaks completely to trial coming we’ve the improvement the in small heard individuals well, also maybe the that’s be of allow steroids. at going in that could say But recently post at reducing the off that conferences investigator, on XX will to

new a I think XXXX. and the to like whole to a steroids patients therapy they of this maintain get attractive to of steroids here that want is and points really burden off with really it life quality

Shawn Egan

Thank for updates. the Great. you

Operator

Thank you.

Wainwright. Our next from comes question H.C. of Chen Yi

open. is line Your

Yi Chen

the first quarter, all results my you questions. safety interim report you Thank doses? taking will safety results report you question from is, fourth when in three for My

Sanjay Shukla

I Really want Yi. the is three findings report say the that way at look Hi, point. of have for we all at at to it doses, the Yes. blinded that least patients I safety

to that be would I messaged multiple think in ascending we demonstrate once after manner. doses serial drug, tolerability our of certainly a start

that X we safety see our on information look received trends and of and So least a ensure of we what in if see that what the saw all and similar good they to get basically I we preclinical to there tolerability start and any at have to drug work. Phase point received patients of that really dose at our would multiple regardless have doses

Yi Chen

the like to the clarify, not enrolled three enrollment. patients dose cohort cohorts one just the into second of get-go filled has the is to dose of that the before doses one correct? are three starting first – from And the Is cohort be

Sanjay Shukla

serial midpoint move two, enrollment. No, into the kind Patients of X it are our milligram first dose at dose a you allowed actually will, the is of dose if cohort. to

want So the next patients manner serial safety it’s then milligram independent look certain they to a enroll DSMB moving staggered to six a course see in take a at X light an you to from to degree. least allow If that. green around milligrams. We at and dose, could X then of

see a component. that’s safety study, here. activity Remember this we’re tolerability same there the staggered to So to a we is and able primarily time but why think is still going at be

not we’re just all X to So X, once. and here, X clarify enrolling at

move of X, the then with starting We’re to as good pretty cohort X much we’ll safety half after be tolerability. demonstrating previous able into and

Yi Chen

Got it.

operating at as Second financial remain question in on the side. to Do you half in the same level the half the expenses the expect first second XXXX?

Jill Broadfoot

Yes. remain cash consistent current with our cash burn our I fairly expect to burn.

Yi Chen

you. Got it. Thank

Operator

you. Thank

from Our of Maxim next question comes McCarthy Group. Jason

open. is Your line

Jason McCarthy

Hi, taking guys. for Thanks the question.

are I bit that general. more So a few have

know Humira? steroids this how So you like they Are ATYRXXXX? to or clarify the drugs is I’d monthly based like safety an if other in to data could be early I about effects? treatments safety dosing know also NRP-X see on see space side We about stage it’s schedules? help expect mechanism? what compare but IV anti-TNF but improved do should you coming, what to profile then there different the And and

Sanjay Shukla

the for Thanks Sure. question.

to kind point of they’re So anti-TNF your – those going being drugs currently off first the label. there, used drugs

recently put So Bop even experts paper, sort out them just What at there and most Dr. paradigm quite observed a of [ph] nice really isn’t the poster have treatment of Bob with yet. a ATS. a

they to a of small and seem drugs those patients. at percentage Looking effective in be

think patients XX% to an that two patients are proportion experienced component is of those have from poised Number look time. a I see issues. and However, those on of that efficacy, toxicity well then you doing patients you and have over And to reimbursement to other one, percentage still are poster, start at the therapies, those that, issue. those for becomes that back go I

have The of lot of actually see the patients. start There don’t start all So they the early you toxicity in you reimbursement see might to you patients. see challenges. that patients was a efficacy, and anti-TNF toxicity I some in thought think a that those They had you work that on. don’t then to work fanfare these

of you Mycophenolate, the being once talking cyclophosphamide, more So about and of first third-line right utilized first the heavy second-line becomes and progressively think hitting to bring got immunosuppressants; nature. then when things you now, steroids fibrotic, that the azathioprine, in about and therapy patient sort the the

by on. Our target many or drug avoiding We essentially progression pathology at clearly in You over addressing models, half look confident of that by a that? that doing early we effects NRP-X so addresses feel kind translational immune inflammation we start that a of the the improved by to occurs can now the see ways downstream of the the models certain Hence, fibrosis. models have have where we’re fibrotic data that effect trying show number our of also which early fibrosis. dozen we anti-inflammatory early have. effects scoring early rodent replace downstream to start about and concomitant animal inflammation And on. is why we’re steroids we in to is the reason Why some spare the clearly on that we think our do it’s of and this post preventing we

eventually therapy when and targets the that change We first-line a can see mobility treatment and our the paradigm really could mortality So we type really of that early fibrotic. help they we address avoid patients that as I this we and therapy really therapy could think also become on. think these be you think clearly bad

Jason McCarthy

All right. Thank you very much.

Operator

you. Thank

Ladenburg LeBoyer comes from of Our Thalmann. next question Robert

open. is line Your

Robert LeBoyer

doses forward safety be just you had endpoints of going it will is Thank is Is of also may be of to treatment the that course full is from patients or of the or secondary study. some Xb/Xa half you. go the answers clarifications it some just the your patients and that the be not reported cohorts? a seeing? efficacy forward the I to all and first, you that in previous mentioned safe several it some to on be the or of cohorts some and or to included all going And for or

Sanjay Shukla

Okay.

I So we drug, in in early doses readout sort say, interim our where are bit asking and how just that little now hit doing to have least I’m data been draw and say of they pause with to what perspective? think study okay, how our conclusions are with you’re right going just data is be patients the to the It safety from efficacy at will a from are treated of three and perspective. a an this clarify,

So that’s what going this on quarter in we’re fourth to focus year.

the the patients that’s to also next out expect validated serum they that year imaging with those we’ll those sparing make activity, then with a with scans biomarker. reiterate improve have at read closely safety look effect, more year, secondary look endpoints to of becoming patients PET look we profile good other the the but their function trial midpoint will qualitatively we’ll at their are biomarkers. endpoints trial inflammation starting testing. at and some We’ll a Next at and again in on focusing steroid to really – to as We’ll looking be if improve we whole pulmonary those these whole see secondary at more see SVC sure

only because that looked signals keep of I quick can safety that’s that and safety have analysis can at that XXXX this of interim just the XX at. year, the all out activity get that that both So with Then read we patients number about at in patients a however we think we’ll on the we data way end it just blinded analyze point.

Robert LeBoyer

lot very of great. Thanks. That things. Okay, helpful. a That’s clarifies

Sanjay Shukla

Sure.

Operator

Thank you.

Billing from next MM [ph]. Jeff comes Our of Schwartz question

open. is line Your

Unidentified Analyst

Thank you the for question. taking

the am to wrong? file is equivalent clarification. When the drug filing ATYRXXXX side will I the that approval or need I use would have with to an than superior to Just steroids steroids? equivalent it’s a then effects, FDA, you show if you think without or

Sanjay Shukla

that we symptoms, that highlighted have controls great it’s of know does then Dan No, drug have of one Jeff, actually and that therapy. progression can actually day-to-day prevent approvable the do that point, the if steroids the you an and things the not that’s effects here don’t which fibrosis a toxic of the it drug,

their think to with I to the For feel having clinician not about patients amuck me steroid when going diabetes or better are run use. hypertension this,

time more So you therapy a can there. their administered of once also think controlling that’s eliminating that that winner cough while a and breath month, where with shortness at the tolerable be I a same have

So you according contribute is and benefits long-term steroids I to IPF of something something it do of also the can course to to that know say steroids, that prevent is is the because that’s than think than even that fibrosis some better here fibrosis that studies. may we

Unidentified Analyst

you. data FDA, to hopefully bar so is a had far. hit based it Thank Equivalency you’ll the over the so on certainly much you’ve lower jump with

it wanted question other is, just The I take doesn’t on it. your related to have this. I

You’ve the got enough next than into almost XX and million in to cash and year into through clearly you data. get more

Your market X on cap Any is at the comments million. disconnect?

Sanjay Shukla

to answer. – think that’s a tough question I Well,

Unidentified Analyst

I know.

Sanjay Shukla

It Jeff, rarity de-risked. and we’re on promises we you do. our what we nowadays outlining, might on what delivered be happening going been do. to work what to recently. in to very as and what’s we’re based truthful on I we’ve a We be we’ve see program what tell can in going the tend transparent and significantly quarter-by-quarter biopharma

job to how even value opportunity given been doing our a we we’re managing we We better careful has We by have think on manage a capital be is to that This significant very I us cash want think that. resources. of here. shareholders.

doing a more here, really this our and that money well disconnect to to be focus on outcome. that hopeful to folks to see But can us. successful then on a good executing then for solved meantime really manage in the job continue and we’re start focus maybe going trial We’re that

Unidentified Analyst

Thank you. Okay.

Operator

remarks. back further I’d to Thank the you. time. for turn Sanjay to this any at closing conference showing no questions I’m like over Shukla

Sanjay Shukla

look quarterly Well, this update in our Great next joining everyone afternoon. Thanks, thanks We providing November. for questions. again. to call Great. forward our

Operator

day. this conference. Thank Thank conclude your a for and you. you wonderful Have today’s gentlemen, participation. Ladies does

may You disconnect. all

aTyr Pharma (ATYR) 14 Aug 192019 Q2 Earnings call transcript