Savara (SVRA) 9 May 192019 Q1 Earnings call transcript

Welcome to the Savara Conference Call. At this time, all participants are in a listen-only mode. An audio webcast of this call will be available on the Investors section of Savara's website at savarapharma.com. This call is subject to copyright and is the property of Savara.

For recording, reproduction and transmission of the call without the expressed written consent of Savara is strictly prohibited.

call recorded. today's reminder, a is being As I to Relations Anne to now and conference over turn the Erickson, Communications Savara. would at like Corporate Head of Investor

today's everyone Good section thank Financial of the savarapharma.com. and Results today, at our for can call. earlier XXXX A issued our X, joining First afternoon, website Quarter press you Investors us May and was be reporting release on on XXXX, found

will on those reliance results and undue uncertainties. today. materially may by you speak of from to not and added today, to you filings Such call you'd be May that replay goals, and will XX. If available live XX on only not website differ like in email the hour matters. and Securities also statements our please financing a statements, meaning or release which conference place those significant received are release is uncertainties, the one today's and be subject clinical available on company's to the due risks press statements after the Federal webcast Forms issued of the studies through the This and company's performance our We Actual if or X-K, Laws, statements Please within strategy, remain the product including forward-looking me the risks the have XXXX, this being May regarding expectations and described ir@savarapharma.com. webcast telephone list, SEC approximately candidates, X, available will call of contain note and forward-looking company's distribution our as for indicated to next be call replay days. to forward-looking at XX-Q. statements recent also caution including A any Thursday, XX-K

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

questions shareholders Time to by alongside like we will also would to these ir@savarapharma.com. to encourage address permitting, questions our via team. on email call we others the However, submit received

and the Officer; Chief are Lowrance, turn Financial me President Chief Rob Operating Chief Rob. call Jouhikainen, over now Taneli Joining Dave Neville, to call I'll on today the Executive Officer; Officer.

important and on for one. release I quick good press our appreciate just do call Expanding for and will coming business as some year; Molgradex XXXX. first plans as our into of we results. usual summary afternoon, developments antibiotic updates our Anne, you, a quarter financial well last some plans months. -- cover Taneli the give progress Thank issued, then on then the I Dave our provide will you the on as future and of the combination share everybody. you acquired dialing will

treatment a autoimmune pivotal me of a you aPAP. Savara and healthy over We let noted to start to treated X design and in health In requiring buildup with the by not IMPALA, quarters disease. surfactant lungs. has maybe near-term for restore who the patients performed risks of a the the option and and funds caused our [indiscernible] antibodies to of fibrosis It progressive invasive GM-CSF doesn’t effect, lavage. formation [ph] constant respiratory GM-CSF the to their comes proteins the only diseased is data general process so recycling. and of pulmonary the the activating to new and growing an proteinosis Molgradex failure last readout burden this under and primary whole lung in recycle ultimately a lipids a impair transplant. aPAP against of the you of story investigational procedure disease and chronic that from lungs aPAP disease and lung, are production available that of know a autoimmune cause impairment, the of lung in is a balance the is pulmonary those So is ability the to the surfactant. focus lead GM-CSF for enabling underlying and significant balance the therapy by or macrophages first a function and leading anesthesia. macrophage, properly call, infections This to preparing If Currently placing respiratory common excess in interest letting a lung autoantibodies lung healthy few is dysfunctional study alveolar GM-CSF remained Molgradex Phase or stop compromising can surfactant macrophages

this page disease, sure IR find please make can blogs it our read you more For on on detailed website. information of and our debilitating to our upcoming

KOL posted on a blog perspective the of Dr. recently we notably transformative GM-CSF most And fact, held one and Trapnell, from from an treatment of was of potential his in In aPAP. Trapnell's leading aPAP. physician the Dr.

So postings case. to recent Trapnell's specifically I do up you sign encourage the alerts, for Dr. read these and

change is and program, disease chronic noninvasive With of this aPAP potential providing address the lung improve the cause fundamentally to a and ultimately we’ve therapy opportunity managed that the and progressive an to develop life. that disease maintenance the of a therapy function way has root may extraordinary the by quality

or we’re the from invasive often at an co-chair previous by or has of XXXX. anticipated lavages. journals. Review this the would break June half XX will for Consistent datasets Peer after the note, study. report only the of BLA results. week IMPALA you potential the Fast the facilitate Track expect Review, for from FDA we like entire our study. I’m with is we for press be the in of XX later Phase early line Molgradex launch instead for they in sooner a and the release period for scientific by that upcoming the following Journal. of to remember in a whole also the finalized. completed earlier eligible to meet policies first submission for in label aPAP. And top will means portion we indicates you the sections that of waiting allow criteria BLA This application June to data half many placebo-controlled conferences our Positive year that guidance, designation as Track why confident of until XXXX Rolling in is to first XXXX results we we publication next of top the disclosure these will line that open IMPALA I Fast remind don't submitting the criteria. may Please us that top conference BLA on which would that with from be with that or that track presentation an of week filing relevant received the for assuming Therefore, Review in Molgradex eligible are the a happen meet and those we lung not XX-week saw line they’re Designation On full that them would of ensure of the planted So Priority and we that week announcing X need the sure are disclosure IMPALA results submit period period

in to in transformative designation an unmet We are therapeutic treating this need how could and it the of the acknowledgment very be pleased underscore with serves disease. as high aPAP Molgradex as

a nearly end patient XXXX, especially given interpret completion clinical XXX% six an us that This a participate including in patients allows But on by IMPALA the countries offering half encouraged of study compassionate of those the for At QX, two-thirds will for use three XX indicator IMPALA-X. patients at the retention for mechanism the We collect having in be arm with full-year. been and us We least of as sites in term safety of on IMPALA-X rate to offering the the enrollment active eligible months, also XX data. that to provides approximately placebo patients in into longer the initially on satisfaction of treatments the extension continue who to beyond of patient rolling to drug optional extremely strong IMPALA drug additional this up into patients out enrolled allows study. all into continue active with patient the open-label extension IMPALA-X, enrollment years with have study. been are treatment, for

we the quickly additional you readout, we in are the remind confident let near data why the reasons As me of program.

GM-CSF millimeter the reports. the through impact exogenous extremely inhaled well autoantibodies GM-CSF case XX is XX% over for studies Adding sorry, overcome than lower endpoints of numerous effect above treatment show and powered our of statistically, endpoint, physician XX sponsored of assumed XX secondaries. range of and and studies. is -- well millimeter power is Recall to Firstly, the only key that of a its endpoint XX known believe the endpoints. to the for primary well logical conservative mercury are not published key aPAP XX size but characterized about primary GM-CSF for the mercury observed improvements two, secondary We XX% pathogenesis is the to primary in were powered we study the that the concept. XX the IMPALA efficacy Number the as key for also is to in

for published our of study Questionnaire the walk was meters Regarding the the in Respiratory pulmonary XX the improvements within effect with is idiopathic the St. for than analysis demonstrated studies and finally will size the improvement in cumulative or on six-minute of points not expected range applies TESARO secondaries demonstrated assumed to used placebo XX the And dosing be fibrosis IPF George's as which as regimen. dosing dramatic compared rates which typically continuous most higher primary import of alternating IMPALA the in aPAP. response dose the in our in an a

delivers of to a to published device XX% which nebulizer Pari used delivery the the addition, in jet In studies. eFlow lung, of XX% positive the to the than XX% dose drug is of the higher typical XX% about nebulizer

a is other to clinical OPTIMA progressing top study in mycobacterial the Molgradex a lung people NTM NTM very for study Xa with evaluate to treatment patients to with and cystic of nontuberculous next guidance, In Molgradex and initiated study expect program, line franchise year. is line QX Xa with Phase recently study. fibrosis. results infection. This treatment planned This continue new And ENCORE. the we the OPTIMA's of from [ph] fully we to our within study as living the for the enrolled or design is called evaluating similar Phase Molgradex Molgradex everything study open-label of Turning

That are the successful, numerous cystic Molgradex more to approach. enrolled If XX%. of that program, program Phase helping especially for entirely of refractory With the we're had Enrollment the the than is inhaled stage, analysis continues XXX. optimistic largely patients fibrosis rate the failure NTM, the the relatively failures to if to and X population boost chronic years XXX natural early and age, vancomycin immune they is lung other our lung Unlike time antibiotics to challenging. of NTM target screen flu The screening X infection. approximately infection. a anti-infective in treatment change and lastly we attends for Currently occurring way definitely and seeing primary screen the the see some study bacteria between takes are Molgradex treated. defenses, system study is immunotherapy in effect most the AVAIL [indiscernible] higher of screened, approach potential an be move lung between randomizations, other tough of AeroVanc let's due in the patients pulmonary potentially XX considerable XXX clear this season. out recently subjects for of of we an a directly, exacerbations And that’s target total and of infections. anticipated. and infections And is the NTM we body's still potential. program Molgradex very Although are about there's

However, to burden demonstrate QX MRSA of boost by randomization efforts affected a the a to that enrollments, number patients complete the the and better the IMPALA-X, are other exacerbations until compete long and are investigators to reinforce numerous disease activities, treatment. as line start requests including response have efforts the we of on to from and this efforts also in this considering of such program time of clearly to in would to we large reaching the as XXXX. these adding drug underway these receive drug will study With numbers patients in new need by year. top quarter incentive remain screen to remain enroll guidance steadfast activation In study. reiterate and and access for enrollment and of of study, a our allow a hopefully expanded to for for patients high list completion Similar patients high help end FDA we our following the sites are data to the all prior enrollment Multiple second do approval.

over call Taneli. the to will I Now turn

data data you, committee developing development year these Thank manufacturing disease of guidelines for with on KOLs next thereafter and antibiotic have plans as of IMPALA to one and pulmonologist our To programs, any Activities leaders for an and awareness, obtaining Molgradex the would ensure access an read, key with the confidence to support well Dallas our our inaugural American aPAP for focus necessary the treatment to on describe our large last presentation education, and earlier our to patients focusing acquired to underway areas. include Pharma. defining U.S better our in Rob, now payers disease reimbursement considerations. practices stage Cardeas initiated U.S to your evidence just good efforts pricing from Among begun afternoon, test international well of of research and well including patient first prevailing Society our underway care, prior with are the the and Thoracic like strategy plans preparations pricing journey and is in meeting meeting through assisting interviews to steering understand I effort and market research work opinion streams to practices designed and global all market diagnosis landscape, in we combination the with as we support of key have obstacles best market commercial expanding week. everybody. the aPAP in-depth we we nuances with effective commercial the the a the project Based of launch. attention quantitative

research our Additional economics market which then parallel, health Health two-step as programs, This initially serve also European pricing research access access In on will for Authorities key benchmarks markets. facilitate the context pricing at process being research continue with and work from the preapproval conducted the and in and in payers in as This Europe. expanded can eventual [indiscernible] modeling. a we is outcomes commonly looking within diagnosing input post-approval but work treatment modeling and currently established also of launch, in economic U.S the includes economic full for not defining Europe. only to on nice the broadly important refer other U.K's This more commercial specific aPAP, centers the [indiscernible]. of impact economic gaining is regions on U.K of

Finally, the critical factor unlikely aPAP identifying our strategy and finding of the patients. commercial most success will be

test uncomfortable to a parts GM-CSF many the While biopsy, will as one available. invasive half there aPAP are that’s Right effort, that false-negative through ensuring results. widely still can more major patients moving of lung as now driver many this sometimes and be diagnosed autoantibody yield procedure blood are and bronchoscopy an

the have As often in the of they aPAP absence associated considerable this true higher testing therapy orphan can to a and and Even has a shown to in been with and better disease. Japan other diagnosis. centralized increase be new awareness diseases, diagnosing seen lead approach the in a of increased treating awareness to therapy with where new more is

patients estimate seen have estimate aPAP as Japanese prevalence the years people, of and aPAP a updated seven per times seven Xx XX being than last their as with million the recently patients is million. which of consistent the per published diagnosed much Over is increase higher earlier in

increase and we a yet the blood an test the rest U.S same that true identified with for therapy data simple have While in to aPAP suggest approved of we or the awareness don't to of all likely do coupled increased world, diagnostic patients the is believe is the of regions. effective number

we in the the to proprietary entered Biotech. cell to terms manufacturing, about substance the commercial and I'm of look with scale. supply GEMA commercial happy advance all will and forward validating drug regards that our commercial insights our the GEMA with into at of last with line. of streams progress substance With longtime sharing agreement you. year, more a our As drug now our new the from Savara's report production we next recently Under expressed partner call this on course spoke work us agreement, to over of manufacturing supply of exclusively GM-CSF the manufacturing findings we

the line we on with forward top up look wrapping you sharing results So much to IMPALA very Molgradex, shortly.

stay please are exciting tuned. times. So These

Okay.

to let's then move exploratory So program. on our

acquisitions, our indication of ventilator In inhalation X amikacin/fosfomycin study through but excellent the a expansion acquired strategy benefit to Cardeas, a in by failed antibiotic consistent show associated solution Phase we efficacy As demonstrated part top pneumonia. to Pharma. product IV from antimicrobial expand pipeline this Cardeas antibiotics and completed in lungs, the combination unfortunately of on

the exacerbations. of the is to abnormal a we by characterized to will chronic refocus with world. pulmonary chronic over the people lung with non-cystic frequent estimated Going fibrosis in forward, widening the in bronchiectasis prevalence similar and airways associated in of chronic lung bronchiectasis The infection. infection Non-CF elsewhere development product disease XXX,XXX is U.S well and a with the patients disease impact Europe

making is unmet yet for predominantly adults, high in increasingly aging find the specifically no As approved as prevalent, bronchiectasis Currently medical this bronchiectasis. is therapies there older is need population are rare an disease. the disease

and macrolides antibiotics used off frequently are inhaled oral Although label.

new indicates neutrophils, hospitalizations Patients market bronchiectasis malaise are lungs. negatively due own inflammatory treating of is with Amikacin bronchiectasis Our lung quality that is underlying immune to infection, increased research the and immune that potent pathology in and of aeruginosa. killing infection neutrophil be most with the Fosfomycin, function response a often And is with among bacteria and a reduced interestingly exacerbations, the cough life. a can productive impact scientific and mix improved of demand against in chronic has patients high effective typically treatment gram-positive gram-negative by clinicians. present all which safe against dysfunction therapeutics riding MRSA. The activity infection. Recent including amikacin bronchiectasis a of GM-CSF. damage type defective pulmonary antibiotic of of pseudomonas particularly bacteria and with us, the reversed also activity against cells research common has shown that other bronchiectasis, for bronchiectasis on bronchiectasis, have in of in abundant pathogens hand of common number

amikacin/fosfomycin to both locally anti-infective opportunity Molgradex each having mechanisms therapeutic the to of and products pursue dual while form synergistic an products, two of allows combine of potential effective in the different immunotherapy us with bronchiectasis potentially patients with standalone So have administered antibiotics strategy combining as in action. these our Molgradex,

where that Our strategy antibiotics. oral studies top is lung already infection first X two care of standard pursued being earlier dual of application this in is NTM the of reviewed administered of Rob Phase on Molgradex

amikacin/fosfomycin only and study release will and Phase will clinical of of be early online. crossover or year amikacin/fosfomycin combination a alone the our anticipate or design we're of for Results direct in bronchiectasis between the manufacturer not to by these help potential in studies bacterial study the indications. first to a therapeutic Our in study separately with arms. study the the apply establish a randomized investigate utility washout after will recurrent this combination will The exacerbations. XXXX batches of reducing with X efficacy now in and but patients of product to later load infection GMP Molgradex start enrollment new approach products future We bringing also in bronchiectasis, the periods

our trials, for good treat to this interactions be aware a of and therapeutic and have opportunity been a broad. uptake size, with in its sense bronchiectasis of experts of based where the and who important care attractive analysis a have research infectious level field regularly of this for well the rapid industry, what biopharmaceutical market, but need our the be Equally we difficult given target are Through specialists, -- and be our is is needed extensive lies. that to unmet effective disease primary our approach very would now we past and the successful market believe world on We pulmonologists, has also safe a that among indication. bronchiectasis, this expectation physicians been

update. as with now And a as eventually about other learnings call forward on detailed you over well financial this programs, As our information to our updating Dave to and much more program. regularly the we very pioneering our for you I'll regarding progress thinking look hand providing

$X.X $X.XX stockholders and million with stockholders everyone. ended incurred for months $XX.X and common March TJ, hello, share the increased months million XXXX. with Molgradex. was XXXX primarily due three and costs ended attributable million of of months This of for the $XX three to administrative the development with months associated three to were General expenses net ended per XX, Savara three March the or per XX, for million XXXX for the XX, development ended for March loss activities. legal XX, $XX.X or to XX, $X.X million for with compared personnel primarily and loss costs Research a three to were XXXX. common share the This ended million three months expenses Thanks, March compared $X.X the XXXX other XXXX. million March insurance operating March and months $X.XX XX, attributable increase a of compared accounting was ended due net $X.X

sheet, XXXX, thus call year. had of the XX, and hand equivalents balance for $XXX.X sustainable carrying for into ensuring are a while next pivotal we our And funded short-term value of As Advancing a of are $XX.X data investments million to remarks. March a we managing In position our closing approaching pipeline back with will will success. Savara us its strong now part cash cash, approximately summary, Rob the I expenses had sufficiently readout million. closely latter that and of of debt approximately

everyone Dave you, Thank call. on thanks the and

questions company disease are over Savara, building sharing of paradigms, Ann our will with the of At can appreciate lung positioned plans medical encouraged long-term. for number the questions multiple do we’ve we X we from we’ve the to unmet be in of scientific by eminent [indiscernible] growth that non-CF like a better via of short-term beginning new be study, we for lung we diseases. that, against email Analyst forward questions. to the need I for answer and any With in advancing Jake while our We the that for submit an year study At the would understanding growing the executing development transformative could and successes catalysts to these that As IMPALA treatment permits address outlined, sustained a Phase we followed with our Savara. received. your you. other orphan And continued are time pipeline are call, our orphan our bronchiectasis Look back If turn call from to successfully to launch ir@savarapharma.com. readout shareholders believe support.

Instructions] comes David The Please [Operator first question from Jefferies. ahead. go Steinberg with

afternoon. Thanks I a questions. and couple good have

the First, to and territories? you give granularity approaching you development little of finding effort? the strategy your share Molgradex us anything pricing with could those you how you last PAP Thank are second us Molgradex. more a U.S have a whole [technical on as has of end your difficulty] business do with commercial individual patients? Could of the the or question about To of Do Is interest? development. Japan for you. latest what specific thinking And that reimbursement a the thoughts And foundation? health give point, to or ex-U.S economics

with the for This First, questions. you Rob. night. is you having Thank dinner hey, It David. other your good was

me Let answer the as Molgradex Japan. far question first in as interest into second

we interested of and the take in partner we of We geographies. then the into and Japan have Europe already and obviously key partners remaining geographies expect in ourselves some some to are

health Taneli I that. will to granularity far to hand As as on economics, the respond to

David. So, thank you,

the perhaps me start important let think is with part, which first finding patients. the I most

us allows high of cover patients. now to focused all right remarkably is researches, our different proportion on number research So which U.S of database a

lavage. who We actual whole access claims patients. the are we the lung can can database and access including what broadness the So use information given, their treating research these can of the are where diagnosed being about this treatments of doctors patients. We access locations, also means

that launch. pulling commercial And that education constitutes and through it the for then so rollout believe by organize diagnostic, more be it hopefully us all to of information And together disease the come to will put all state we lab the this broadly this our now us. position boosted a will the right good in the core we're in of

I economic can't [indiscernible] about In terms share detail of that. modeling, much more the now right

the We as rolling know, include, data will then details the also read. forward this understanding the until learnings of pricing you But different then as be go of of going we will time to launch. elements more out of perhaps the whatnot. not approach And disclose our are we after reimbursement

Okay. Thank you.

The next Bayko Securities. question go with Liisa ahead. JMP Please comes from

Hi. Thanks for taking the question.

about bronchiectasis. is question First

you background as very combination what provide we choice So from study? of some in indication. for of to evidence should the this bronchiectasis interesting Can kind be may and expect the

So the evidence really exactly? antimicrobial bronchiectasis the know second question And on have, is type aminoglycoside itself. that to Liisa, we in the combination antibiotics was also similar your apologies, effect what from and based

Can study? asked Oh, maybe of just that over I through on patients months. haven't CF I of thoughts enrolling kind kind yet, of just in talk the four but about the wanted to you you XX maybe can kind us walk for that

the For AVAIL study?

Yes.

a in successfully enroll recall that huge the able quarter may you as IMPALA in hit our still guidance. almost last and had hurdle we we Liisa, were to So,

said bear And fruit. of and starting to a steadfast. so back number we now got a of hurdle we we were many started -- while earlier, that just It like remain is I underway, a activities these

we will will certainly if we So and guidance we give don’t think you we’re give committed to to going -- we our updates remain hit any that.

Thanks. great. Okay,

question next from comes The Steadman Dewey Please Canaccord. go with ahead.

Hey, the and [indiscernible] for guess bronchiectasis. on guys. taking question. I Thanks

only moving will you forward. to on run quality-of-life endpoints? on then what endpoints, $XX going or or you something And focus In FDA be endpoints think on good like CV-X looking only been a microbiological do trending focus think they it's they can a around million more R&D, it's do rate a That’s quarter. like or is forward, or at functional terms distance walk that, fixing the of like

you As underway. have always studies Thanks.

the first Taneli one. will answer

Right.

the microbiology of So, product Lung Dewey, endpoint and an will non-CF is good not [indiscernible]. pathology not function given as good marker clear also it the through carry endpoint. is disease that a This approval. a not very a for

studies their entail quite have use that precedent for pivotal the there's of So this clear. using indication exacerbation endpoint. and an now expectations will as And of FDA ample made pulmonary

in front path of us. So pretty good regulatory we have

to more gain population. Our the essentially surrogate first some also strategy quantitative approach results our dual of patient endpoint simply study, though, a selected and treatment study understanding related to be of some will test the

about Dewey, the spend. part on then the second R&D Hi,

While we that quarter, don’t get and QX. our to focus just comment AVAIL give to specific as on there's we’ve guidance is can on what the on a said I

activities expense talked so are Rob Certainly about is And rolling on. that there those there.

mentioned the also amikacin/fosfomycin We study.

new about our coming there then we’ve we So also and got cost filing. in talked

cash we deep readouts committed you So XXXXs. gets our into are well our ensuring that to and if all think about that, us through

a exactly follow-up on patients having there that to are does exacerbation? kind exacerbations. if FDA that, of determine exacerbation. And classifies Great. criteria just What diagnostic What

Well, of course some where suggest freedom companies is what feel to they that is best. have something

big meaning better most the exacerbation more patients to an the sensitive We placebo. treated in recording than to system. if antibiotics in respect, physician. believers is differentiation by a reliable with is your are were the find way the see seems and It this typically a And that simplicity also between drug

Thank great. you. right, All

comes ahead. with Thalmann. The go from next Please Higgins Michael question Ladenburg

taking the guys questions. Thanks, you. Thank for

data. if are want clarify, close IMPALA Just getting to we to

or in all at things that you that any anything CRO like the getting? from updates may patient have for If that of along the Reasons trials. way discontinuation you’re the rate include number the like

So, for being call. on thanks Michael, the

we said any numbers. patients we’ve a beyond low, we we’ve that the that What discontinuation enrolled XXX but specific So not disclosed disclosed not have it's rate. is

That’s Thanks. Okay. helpful.

even at in look out U.S. you If Europe, actually

an have reps of in how on us both the update many If you strategy, marketing may those regions. you give can specifically

on the is number still Michael, of and depends of reps somewhat number our factors So, from a research. undefined

country-by-country will finally in right range. the not In commercialization, efforts Europe envisioning ourselves been and the own region now of in terms in vary be exact we sales U.S the we it terms to of our to geography of compared the in are We has what reps number XX% of to of partner. XX% what set yet do

kind then of make partners it factor and does look the the European discussions the determination [ph] of begetting at you from there? And or do strategy, what’s Okay. a European potential data of the follow decision,

where option rent sales of are is parallel sets of we a then partner have all can launch. of it now Yes, alone the options, we any all partner in we the buy capture And we right ongoing launch either these options discussions. a so basically sales option that’s Europe an product considering have or say do that what three we to or and force after number go force up called we years and I to in to

I Okay. And Not answer, follow-up got trying after talking on or an decision that you you thought with process, make how make once something you’re you quick that a then partners just there. just get decision? looking the new Is guess. to do for your [indiscernible]

I rent of do all needed terms buy those have our thinking, well by. potential discussions commercialization. be a of our our The own different this more what at of terms have option parallel ground own the perhaps these strategies as key of but as I preparations partner as exactly up in will and of do this our in candidates a of in and of considerations All also specifics to impact to be well decision middle specific apologize, bit then the point. sense of first, the little markets as our can't how opens That

And color. Michael some to just add

is results. So intention we announced what our June line top the it's when in

time, a say lot and lot will more the we will on be are at point. able spend that commercial We already plans launch we a working to then more

are risk and technical we the us. holding just have so behind it We

I appreciate it. the for Fair color, guys. enough. Thanks, Thanks

Instructions] [Operator

are came got If there questions, a of questions in no couple I is email. this that Anne, over

improvement whole in lavage take of given you a one? in results lung that many that to lung Taneli, And group given do impact an the in want negatively lavages? study. hope see is, placebo that you do is lavage critical the not one to results [indiscernible] the First AAD

Yes, Sure. Sure. okay.

if you of what allow that is do patients done realize high. to need whole And rescue treatment. a lung treatment arms. whole for So we it in all lung is that patients threshold our course, require But that a a is of having actually quite of lavage lavage,

period. trigger lavages who from lung are in The whole baseline see lavage. who and line that will the get would essentially to expect patients months lung patients over steady then their wouldn’t six lung at definitely course their you of lavages and will base deteriorate, the so And right,

will worsen certainly study expected probably the Lavage. patients get actually on during not that means some some the even average lavage who may, improve lung this to So with are

So overall, the answer is no.

all than that endpoints. with our to rather hope clinical endpoints. not because of are And concerned also is have the most about other interfering at less, means in the this we of terms We lavages arguably this actually more lung our lavage important

see with I well show lavages a will they’re long of of power. think And enough good actually to there, in the shot them. results So statistical have as as better therefore enough significance as more statistical the terms already we whatever

came more that one in. I And got question

drug how select As for not them substance? manufacturer did [indiscernible] your as you chemo-biotech,

Okay. me take well. Anne, as let that

GEMA natural for is actually us. So choice a very

risk source so the XXX% gentlemen, is they the our opinion. who history we people. fact same of the in able standards, currently clinical And the which was founded a regulatory also is have all, and plant, had cell founders They’ve the manufactured continue we company great by development. that these owned by And for who lot of importantly, were of those everything company Struengmann Novartis. to generics developed the are the they high the also brothers. of same very same are long the owned clinical of that essentially German now supplies, First is supplies. Hexal, company quality company with of nonclinical a equipment, in don’t just with is of that a and as all GEMA They done now in And very it's our science biologicals trial, the the course But for GM-CSF. eliminates a line

of quality pleased ownership And biotech we through more be hands collaboration. -- the operations the couldn't there. solid with and area history their our of So in we [indiscernible] that

this is a And perhaps instead which so fee-for-service totally a engagement, partnership mere in represents of true manufacturing. contract typical more

for front IR coming I appreciate Well, you investors. thank that. from on those questions the

no for call. said, everybody Thank as we think And in. have questions joining the more coming I you

question-and-answer for to Neville conference Rob over I session. back would the like turn to concludes This our any closing remarks.

Thank I most And years, obviously exciting the really exciting for you Savara everybody. this up coming most I’ve think time. this now we’ve months XX good in been is now Those were and is got in questions. June. it. the

forward announcing then. the So results look to we

Thank Bye. you. care. take So,

is presentation. now conference concluded. The you today’s Thank attending

disconnect. may You now