SVRA - Earnings call transcript Q1 2018

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Operator

Welcome to the Savara Incorporated Conference Call. At this time, all participants are in listen-only mode. An audio webcast of this call will be available on the Investors Section of Savara’s website at www.savarapharma.com. This call is subject to copyright and it is a property of Savara. All recordings, reproduction or transmission of this call without the expressed written consent of Savara is strictly prohibited.

call recorded. today’s reminder, a is being As I to Relations Ioana like to at conference over turn the Hone, would now Savara. Head of Investor

Ioana Hone

materially joining including be reporting Thank A earlier contain of financial today, Brian. May note Good XXXX on or performance uncertainties and those differ and risks our statements are Such results and the statements issued our at today’s you only which conference speak and reliance significant you, risks due laws, and Forms Investors XX, can today. XX-Q. expectations those subject our undue will of forward-looking place afternoon results savarapharma.com. Actual statements described on including was to press federal on first to caution to webcast by recent our from as SEC meaning for the of not the Please studies release that regarding XXXX, X-K, X, May and quarter the found today XX-K goals, filings XXXX thank forward-looking of press any and us. website strategies, within our Wednesday, We and statements forward-looking clinical our may in product statements uncertainties. securities call release indicated issued candidates, matters. you financing Section

the the call. of questions end usual, per at field will As analyst we

over Rob said, questions With to will email of Officer turn our well we the our Neville, to investor would of call we to Chief received team. to time recently on webcast Executive submit and permitting, call address like attempt would via as However, by page like those some encourage send the ir@savarapharma.com I to that live as others the Savara. relations to or an shareholders

Rob Neville

you afternoon, good excited joining today to speaking you and to and Ioana am I be for everybody. thank us. you, Thank

Overall, our will will during concrete shareholders, bit we exciting of focus will we continue opportunities to studies. for these Lowrance, as we points we growth did ago, respects. President an with the for will the our that a learn grow Officer. year our area more as April, COO time a was clinical study our clinical this on year of believe as In into with a on company. orphan a better and lung building and some to we guidance. benefit outline days which now we’re engaging is be me ongoing, will provide OPTIMA and quarterly of one AVAIL, more is we’d in studies In a on remainder have Taneli be this With you status, continue progress many our end with our start we exploring Jouhikainen, public new a bit like visibility which focus changing of well prominent those Texas Savara usual, of quite as see as a accomplished we the momentarily, about pipeline in being corporate of and organization data to At advancements expansion As the our further the celebrate four IMPALA-X, our shortly. Austin, Dave and which year we enrolment Chief XX believe milestones continue our communications, disease IMPALA, the and support this little anniversary I company. little and here short in meetings studies actively about parallel, to shareholders granular many for information talk more these our help into to Financial

to call our clinical of studies. the First, over me to into progress hand delve Taneli let the

Taneli Jouhikainen

afternoon, Rob you, good everybody. Thank and

the IMPALA PAP. treatment study with Let pivotal begin GM-CSF X for Phase of Molgradex, autoimmune inhaled me our of our

into as from reminder, of expansion sample on of we as as February in IMPALA earlier, XXX patients was by around study FDA our XX in IND US to check blinded a based secondary the a the for increase interim variability two the the size of already First, key the as disclosed approved well an implants.

the QX of an ending we a we of XXXX, had patients. XX XX total As enrolled the end patients. XX Subsequent of quarter this a during the year, patients, with total to that, quarter of enrolled of first additional

the by the order in enrolment increase remaining So need enroll the QX, quarterly will rate end to patients slightly. XX of to

activation here in European this to up and up sites efforts the achieve expect nine Australia sites through to to countries. as our the of eight Korea, several sites as new US original in particular in We through and continued of South at all well

of Some to initiated of total sites double been altogether, will number new already and the the a XX. sites these almost have of sites

end do our we site, by Looking data of top line quarter at third enrolment current optimistic the quarter completing role of second and projections, expected remain the of will by achieve country the in by we XXXX. with our that

commitment I who Next, initiated, extension data the like of we a also that patients a start term study. IMPALA-X IMPALA label, XX-month called have the provide to safety study recently to an plan allows reach the beyond patients sites you completed introducing access to that us in months. end the IMPALA majority study new for focusing open rolling minutes main and drugs study. IMPALA IMPALA-X, is a to spend to We our would study to to as safety have in the our fulfills start of fashion, collect few XX on the continued study long protocol patients completing study the

are the Some of follows. study key as the IMPALA-X aspects of

as off IMPALA can all, of open study study the the label dosing with week week Patients First in to in of the the participation years. on, continue portion for regimen. the three the up same is alternating

assess responding maintenance primarily many of to in focus study safety of the parameters and the also treatment the We collection on of effect endpoints will IMPALA will efficacy data measure patients.

by enrolled, encouraged toward study patients very with of thereby interest the early the administration. only the the drug very While and study toward high continuation still we are two

provide study very well insights satisfaction of further desirable enrollment may the we duration the of treatment. forward, as as early metrics to of some Going Molgradex information level with relating believe this interesting the into

a So on OPTIMA update since our our like Phase moving to for with on, had I we and of you last very and infection. have NTM. the treatment due time the more times long to now initiated Xa next, treatment. March have culture lung We screening half dozen Molgradex study slow in a then, would NTM the from four patients which quite typically screenings line started the guidance than a active for is in of study month this is to study, already and who with In enrollment,

complete XXXX. all XX to plan XXXX QX quarter enrolment to As we've previously, outlined second and patients report top line of the we of of by data expect in

OPTIMA we there factors. possibility and already that a study, year on provide the the by since an open-label interim enrolment is some However, would results other is end, depending

best, system. In the this anti-microbial immunotherapy. the with infection of without either is other So use believe in this words, localized that, anti-infective concomitant or Molgradex stimulation immune we with really in treatment world the of products. At new what a could opportunities whole of refractory if of with the paradigm innate of expect open up an like works NTM, traditional shift could lung beginning a treatment exciting makes study represent we do

being younger with you of the month we subjects. approaching of expect to whom total XX States fibrosis. far XXX. completion brief in in of would the current of our in few age. MRSA our years I of enrolment of subjects vancomycin whereas the our pivotal already XX a The relevant first finally, than cystic like sites optimistic so data adult in population subjects, the already Canada treatment for lung most XX the continue of enrolled targets the to study slightly for out in remain initiated enrolment update the well XXXX. end number comprises And With with X Phase of analysis enrolled of the a end of for in guidance enrolment the enrollment this our provide AeroVanc, we the first rate now quarter the fact the maintain to follow goals. to have is patients exceed and of clinical we completion AVAIL too observed increase meet have first more an year, metric last population quarter further in top we AVAIL Subsequent X enrolling, XXXX. our inhaled expected subjects Enrolment our will primary current still total been with study is of during as being required to ages, XX include by rate XXXX enhance as encouraging of of therefore sites the patients, function summer of of second conducted enrolled study enrolment of as certainly are enrolled and of Therefore, and quarter. half our line This during of the line The and nice as that, all across sites well XX year, that QX September of enrollment we and the the the enrolment so patients interim to this XXX all almost At the United at the younger we a younger guidance quarter. the added our a we additional currently with more the first nine

financial to that, will briefly quarter first hand with you, over results. Dave review to I call our to Over would who Dave. So like the

Dave Lowrance

expenses our or everyone. net to to share were and expansion the QX with including shareholders Aironite to compared afternoon, of share negative were the XXXX Good QX, million the negative activities in and first attributable with compared shareholders for Research and phase as Therapeutics $X.XX of per with $X.XX XXXX. was Taneli. Mast our several per NTM study, With additional the of in administrative X million Thanks, increase X.X when X.X acquired to including million related XX.X study, Molgradex, quarter costs comparing million respectively. development merger results, attributable expenses and development loss and with increase the and related loss the X.X for respect a due to development common the in common X.X AeroVanc total study a XXXX X.X to XXXX X.X or in April X X.X of XXXX, of study million was QX expenses for a associated in aPAP totaling million commencement XXXX. an to QX of factors, in costs QX million net million US milestone consistent and General this

in the acquired pursue charge a do Aironite Additionally, XX.X Phase the support against not we to impairment non-cash related to X we This million program. during accordingly, intent which assumed of of charge merger. the QX, R&D to recognized program, one-time Aironite study failed we process the further the or one-time had Aironite due was in and

of impairment, off tax result X.X million we liability As fully a tax the deferred the wrote credit. of and recognized the associated

approximately XX, of cash investments had XX and As balance had we approximately XX.X debt XXXX, million of of and term March a short cash, million. equivalents

financial while to candidates, product always, execute balance As our studies our clinical the aim best decisions we support manner. a our continuing cost to effective to in development of

sufficiently We current believe remains company into business funded continue to XXXX. our to plan the execute

the call hand Rob. back me let to Now,

Rob Neville

and Appreciate it. Thank you, Taneli. Dave

expansion side, vision indication company, and we to actively become a development business the On lung disease opportunities prominent our product acquisition. evaluate orphan continue to with for consistent

acquired was NTM, its a and beyond in now we aPAP product Molgradex along valued Our it into asset. is highly believe XXXX expansion with

will stage and clinical new other this indications assets. on success to promising identify continue build to potential We and

lease new goal corporate regard one at stage within assets pipeline XXXX. in clinical or to Our to this indication our add is

projects we appreciate pleased will from of greater see continue to can studies our to to and including in the quality each line We we're you our granular make. and to with last steady to quarter, in deliver enrollment determined to our As I progress, highest are progress provide possible efforts the with remain the updates. transparency our in hope guidance. achievements very we very committed best quarterly our more you complete all with numbers key future doing status our and focused

the to following. so, include then, year key events summarize the to forward And look to this

live our quarter First, the and XXXX, enrolment results the our patient to study year, through third mention we encourage at IMPALA enrolment call completing just possibility either via on would line like that of I email questions of top relevant OPTIMA we'll we our the updates recently in in in will attempt related calls. and in quarter to expected Investor the related an expected webcast team or from shareholders them well the address depending providing, possible our also four completing new XXXX, beginning studies said, study quarterly we Ioana did be of indication as this growth after acquisition. ongoing patient of and as submit to as product others interim permitting, lastly, expansion and just pivotal to to simply updates of send ir@savarapharma.com third the study to time by address or other Relations the analyst enrollments received OPTIMA factors

And so with call I'd the questions. analyst Brian like turn to that, back to for

Operator

Instructions] [Operator Canaccord. today comes And question with first from Steadman our Dewey

Dewey Steadman

Will guess FDA of visit an original able I want that success be you'll what do IMPALA-X, data? how like as a you those you the you the and to enrolment look see to in submit the schedule terms be consider interim NDA? the relative what’s be with percentage And do to And then existing able a for of on have that anticipate patients the to study. will to population

Rob Neville

Okay.

because We I actually three perhaps is of But extension questions. see necessarily to still into the a out, only do what to roll first study. hard it little hope the patients the do predict how factor. will continuation So this the suppose in to interesting, not of terms the one see we majority expect most is all so the patient over. satisfaction is turn

sure calls, will So some how we in progressing. are things start the giving of you updates coming be to

quite frequency, As to it the be patient will visit infrequent.

we between length we then is So This requested provide in what would be an interim be going do visits whereas so. intervals beyond of month will the been FDA, this six I of submit and the to treatment. believe there to terms to of have

it welcome a think addition package. will I So to our be

Dewey Steadman

PAP Does visits that to six-month correspond the with visit tertiary interval specialists? patient typical

Rob Neville

after when between in study. part completed our months patients, three better a of would at it a six Every out is they're as all. they be really they've be lot often we open could hope label months shape every There sometimes, quite would be not of range

Dewey Steadman

don’t two And quick out. then want financial questions, leave to Dave

I rate of that how It's factored ATM, is that going and into that bit this in forward. approach is been a was there that, that quarter-to-quarter. a expense bit we How good the On much quite facility quarter varied I little should left notice then but forward. it seeing have draw. some SG&A know a there’s a things going external run we're

Dave Lowrance

both questions. Dewey. for Hey, Thanks

guidance of kind of we order. refer me we costs reverse with what shift kit quarter-over-quarter, specifically to as intend as and programs to complete past, them the talked I mean while two we've Let enrollment to is X when that so we in can’t now mean, I respect give we've we enrolling said the phase in there, those, start away. to about, will don't have

map we mean a IMPALA-X. news The study of -- can hand, kind of the there limited That significant of to patients from entered out cost, Wainwright. while that So a with cash ATM. And we as is, can $XX with we have us it ATM, And new year, great specific months. current if confident also into again, we agreement not where an at you look on and then into our with piggyback that a don't expect guidance on sales this XXXX current respect our H.C. the saying we would straightforward into have XX you operations. should the remain announced get last to guidance, next give impact put actually fairly with therefore, to I we on million us referenced over that back a number then that we was it's

But made, first to in that us that. million to to disclosure the That respect you. we’re quarter, about believe driver million with in around I’ll that I us. the and the $XX the should number. confirm at. we’re confirm XX get where close puts will we left mark, that be that I for With but available

Operator

from comes Liisa question JMP with next Securities. The Bayko

Unidentified Analyst

Lisa. there the what lag that bit OPTIMA. mentioned had John on your on a screening, the taking for actually -- what In I that progress beyond you is a time enrolment thanks is Congrats saying duration question. this is could doing I you’re and couple typical remarks, that This wondering about if just little you’re into play some other factors you from more was data treatment. also seeing year beginning talk us and a might the study. seeing for

Taneli Jouhikainen

Right.

affect baseline may in what of mean are we the of takes will studies. might meaningful in To samples, get is to all just time that with from and So for the about there's factors cultures the when the that your other adequate all or see then, simply like eradications lag this apart on the And response response obviously cultures elevated growth effects of types That’s we have smear response. we quantitative data is included, rates, and enrolment of order rates, hurdle thinking on to speed because response, we and time to question what that report. we need NTM on may the see wait. may is typical so list. Those sort the see we long of that affecting getting type

So data data, amount end on we report the the decide as may clarity to that depending of and early of the as this of year.

Unidentified Analyst

there an one what kind is focused it just you focus, more guess any of therapeutics something of your more, guys expanding chance bringing in inhale potentially I criteria of more on is Rob of program. you're then is your where appealing And exclusively you Great. when discuss programs, or kind

Rob Neville

Taneli diseases. lung the And criteria give looking inhaled, business are route he side. agnostic I on that, we're we’re wanted to delivery the in of that the and development to of the ask at to wanted orphan focused if So some we but

Taneli Jouhikainen

a areas imagine. niche many there's high indications, do would because at out rather efficacious not. there really is and sometimes on where the where little the but are All fact to and in I very, might speculate what come as and definitely competition diseases stuff be obviously, accurate in through so areas looking are need dozen under-served prefer information, with a to therapies Well, can which the don't we then treatments we with normal what opportunity that with could flip to great we and no than very But of you we diseases want orphan commercially. do

Operator

from Ladenburg with Next question Michael Thalmann. comes Higgins

Michael Higgins

remaining Couple for here me. of questions

talk you their more the and IMPALA rate been IMPALA-X, so based can a about what’s rollover? on on the from bit insights any us If could you expecting feedback give capital what you’re investigators far additional ability,

Rob Neville

safety, a first have So of large to on meetings, we regular this is important blinded which a because of study the DSMB all, is course extent.

had signals no that three there of those of been the and would or have affect four study. has significant conduct the We

over the, really the In here. you and in terms rates to early about sort are will rolling study, well, of able there two to and to of say opposing how bear that extension dropout be asked that go factors it's mind actually

one response good also how the they study, satisfaction feel they I to it want and they may but very, extension could and well, see very about good, a highly happy very patient, move On try hand encouraged to the to very good with be be without. on well if that

want and the that So said will extension. answer of earlier, to don't in play Did quite the that know that is but move to to hope I we how question? out, do majority we we believe like fact your roughly this going patients

Michael Higgins

requirement of FDA patients? Any the does. the It on number Yes. by

Rob Neville

Yeah.

study, who really of extension they to top requirement, by an FDA will us. to what is the they then already the by study. not on – this drug it requirement would the patients what is FDA satisfied access for completed study have so have guarantee So asked It IMPALA the is be

in So allows of the in this nice data made that's a study. do a of and a when to study, commitment in does just to treatments us long a us that the window context give but the collect the we we have structured way protocol term it really

Operator

comes The with next David Steinberg Jefferies. question from

David Steinberg

late. got I on

OPTIMA, questions, I for new it, allocate What the and asked to has Want apologize. several someone or abscesses. other? separately stratified OPTIMA. in what cost how that remind evaluate years said Secondly, cost will [indiscernible] trial can finally, discuss you are And next or have the on in couple patient patients us the estimated for be of to if the you over not NTM the OPTIMA the and program? but So populations would with trial -- the you avium

Dave Lowrance

Lowrance. XXXX. haven't Dave we of everyone our our are what With to funded confident reiterate but So, us into to program to we current get that expenses, any David. Yeah. guidance we This is giving continue business to adequately on studies, we're been is that plan, our specific under respect

Rob Neville

as patients other. -- that least totally avium patients would And with the we both on will or some are we Molgradex somewhat patients, so M standard in the but stratifying enrolling Molgradex label, pushing it's note combination. add we’re or also because top terms as of the to with therapy like as not are the on one enrolment in triple of hand, guiding study, Also, be open be we're monotherapy treating and those will one at a we NTM XX-XX I on and patients, also abscesses to to the well it

profiles of main essentially four have we look will groups patient of types different to So at

Operator

of conclude will session part question-and-answer the This today. one

to conference to back I additional turn the any Rob Neville So questions. for would like over

Rob Neville

do Brian. We you, Thank few in. that. a quite have Appreciate coming questions

this investor We so that, over this believe adjust this like guidance. early the job these. the on. And would first very or saying, one I still the great but see and possibility, quarter question if excellent next on the AVAIL the of pediatrics likelihood the we And a to about patients see So online you a before enrollment. is we're last our an address of first one, study from QX of looks that what -- some believe do will enrollment XX came having we quarter, speaks with the complete we’ll XXXX? earlier enrolment, I'll And can enrolled the than enrolment answer quickly it

even very about say expansion I guiding burn And a Your to running other beyond yet indication appears see ahead in be pursued team TB not being And to if TB? you rate. however a indication TB Could want you of NTM, further. expansion the where add any we’d we're in please are. go some any and color that possible into that Taneli, lean we to first on results talk would cousin TB, before we that just want.

Taneli Jouhikainen

data right So I you're of very Rob, the vitro think that it's in different will guide in non-clinical but us TB, of consistent data terms the much absolutely perhaps NTM remember what might that with happen to is and important mycobacteria. across

it will between between So, high correlation be does different like seem efficacy a bugs. those there

Rob Neville

Thank Taneli. you,

and and you were share to patients have congratulations of excellent you to share the NTM earlier job. for with that a and a dozen team in question, enrolled that more screenings doing enrolled. little We already a -- date. the number Could patients dozen of four than did an actually Another your we

script. And the so that mentioned was earlier during

online, IMPALA sites And I'll that study, with that past why only in question to quarter, now? them clinical activating activating Another hand Taneli. you you're came the the stated you’re

Taneli Jouhikainen

study it's important sites, yet of a the a we study in and very FDA we in IND including mind of expansion. total of the fact, have to new present, had our the XX expansion were approving where yet this of bear active, the we interest US subsequent countries ramping added I Well, part done important lots then are but in that and we've since we not those fact all that good not have considerable a that made in and so in to tremendously of that's up job a feel

of push the positioned we ahead active sites enrolment. So very right well an feel a to coming months, with we're hope in have we expanded now, and number to

Rob Neville

Okay. One last question that's come online.

One treated the the led two key was the to early NTM. previously for study patients clinical of that results

So patients are that. Do the been on two aware on and these any have treated GM-CSF. using you updates NTM of only that two you're have questions patients these

Taneli Jouhikainen

question latter the answer to So, first.

the who Mark of have know other such patients Dr. would experiences. in We about with are recently that I But aware them. been his details first so treated we not with GM-CSF any spoken have about question, to inhaled fact meaningful would Wylam

Now, drug into that is this unfortunately, and And and well. because on, on cannot go what But about enthusiastic treatment they that a Wylam are we the can say personal something favorable Dr. what communication is so. I doing be patients is exactly detail is simply are is it’s continues publication any quite information. going still the about to

Rob Neville

is Take call Okay. idea feedback do the on for Taneli, I you the any Dave call. conducted Well, the guys we appreciate as way that of Welcome it. today. more our please ir@savarapharma.com. well This Ioana being everybody. after with up Thank transparent call. and and Bye. care. directly follow with at granular to e-mail Or reporting, us so feel you the free me

Operator

disconnect presentation. for The that, conference has much attending now very And may lines. concluded. with We your want you you to thank today's

Savara (SVRA) 9 May 182018 Q1 Earnings call transcript