Savara (SVRA) 7 Nov 182018 Q3 Earnings call transcript

Welcome to the Savara 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 is the 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 of Anne like to Investor phone over turn the Erickson, Savara. and Communications would Corporate now Relations at the new Head

us. afternoon you I'm Savara, Good in such can time look and dynamic press financial the a you November with forward months. thank for to A at at release found happy and be speaking onboard and results to at Company, XX, I for issued joining many coming third website XXXX reporting Investors the quarter the today, was earlier XXXX, our Section of be on our of www.savarapharma.com.

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

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

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

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

And welcome very to eventful business brief launching clinical the We our quarter on we you, look engaging excited We to XXXX. number with onboard. forge that continuing on a patient for our of progress communities quarter's have a to the substantial ahead. update this momentum fronts. to we forward was Thank a quarter I'll supporting development an of Savara's you call we're our provide serve, programs, made will recap dynamic entity. by priorities and QX highlights. commercial Anne. everybody corporate the against And third activities transition Today an and enable and as you in

On patient Molgradex the in the development clinical front, two enrollments studies. we successfully completed

We participation physicians the study of studies our make are and on programs to proud these possible. working of committed gratitude deepest these important extend patients and coordinators course this the

a XXXX. final be guidance this that company of was in with couple of the clinical in results top across we aPAP the With endeavor. the remain study including the study in the XX of count we're of IMPALA largest to sites far conducted report excited makes enrollment patients, we This and completed randomized significant within enrollments month IMPALA weeks and multinational XXX quarter last the a for by patient to ever study, patients Hitting line study second IMPALA means achievement the target U.S. on-track a stated our leading

of XXXX, by invested core the our study standard late an launch. study, in confidence closer outcome anticipated commercial medical to step IMPALA of the a submission in would a need. support early we Driven Robust first-half from moves IMPALA high to in XXXX it of or of initial potentially for the our results importantly with the unmet with have leadership the XXXX. in launch transforming care the patient begun BLA preparations facilitate More one and the us population

last timing few a quiet. Due patients initiated up extension three Molgradex, label is study. rolling there out IMPALA XX and of been to to treatment to relatively This IMPALA-X, in continued patients the study rolling subjects an of to IMPALA-X the As study. Currently way months with are off open patients in IMPALA of the offer XX eligibility years. additional continue treatment to allows enroll are extension that we for the have eligible who enrolled the

the Now Savara XXX to the as and very diseases the that announced serve. our of partnership that global with a support August to I'm is In the at PAP all in dedicated minute to improving to living the patient make patient for proud communities organization poised personally a important to we hard desire we to to work advocacy Savara, by community. Foundation, extremely and driven physician those tell underscore to a a me nonprofit there the you efforts take will X expansion build and community, PAP. of I'd disease is foundation's impact organize, lung us and Americans like and we support lung rare patient something the motivator commitment global identified affected and a U.S. diseases. to PAP of with rare powerful one patients more the are are the Through meaningful including than PAP of by million registry. a lives educate, partnership, these this nearly that

to efforts. with foundation patients. community support relationship PAP better We for to assistance this awareness broader meaningful offer also forward look and will a close We educational

focus completed switch NTM later enrollments line forward final lung in top by Molgradex results initially a time We from We to safety XX is will gears interim reporting with patients year. OPTIMA of let's the completed the count the week treatment the treatment Molgradex the interim and in subset and look this XX have culture the to results up results study patient's tolerability quarter who and expected as data to of Now well recently week available XX The The as of on second microbiology infection. quarter assessed patients. have results for period results NTM. and data, points. evaluating of efficacy next

patients to accepted for to have announce NTM program to While Molgradex is point primary conversion be not who been of people working lung end the infection the quarter the a culture has living study have evaluating include we with am infection and IND in will who and to expand sputum I do by OPTIMA CF, affection. with study with NTM OPTIMA, NTMs Similar negative. X we're application this CF chronic first pleased open-label FDA chronic that initiate NTM indication to patients Phase in the CF the expect to XXXX.

suffering bacteria often typically differentiated body lung currently fail In score, treated tests, TB, NTM the from study disease. the to pulmonary of addition develop often the and infection. incorporate chronic change endpoints, combination therapies unique respiratory of number presents toxic, Like index. with a for courses These to that the Molgradex secondary microbiology function will serious clinical for therapy symptom NTM endpoints a us attack with burdensome, are to of meaningful antibiotics and directly. studies, and for people long including eradicate infection CF is mass typical opportunity a

Our approach is different.

immunotherapies fight boost body's oncology Our help ability natural defenses, immune Molgradex fundamentally body's This change enhances infections. it's infection. and we the attempting to to cancer way similar fight stimulate defenses the the to that treat refractory and is system lung could the natural

study problem use explore the increasing Molgradex antibiotic lung of for potential this Additionally, Molgradex opposed anxious possibly of as may we so the We're more bypass by of the the the positive to in learn targeting diseases. NTM. assuming OPTIMA the about bacteria, anti-infective human to immunotherapy can see immune And of response resistance. results the results other

that agreement patent on infection. the but have CF. We initiated lung infection clinical in AVAIL of the not completed more Mayo NTM the the The data an some September to with in than persistent allows at will of we and the that positive for Savara's NTM. use set the MRSA provisional clinical This of and give Last applications Mayo and of U.S. Additionally study applications I'll RT on treatment X XX Molgradex on least, AVAIL vancomycin XXXX, were in news sites was the is our end for GMC on living strengthen currently conducted inclusion is the people lung XXXX, inhaled license AeroVanc study. at recently study This related with a investigating inhaled patent filed across update Phase Clinic fronts. for being Canada.

a XXX As enrolled QX, an Subsequently total of XXX ending quarter of the we out the quarter XX subjects, additional the subjects end subjects. had with we third XXX. the enrolled during of planned of

the X for XX enrollment comprises are completed the is mentioned solely QX the of whom subjects the younger population quarter. now last adult on subjects focused subjects, analysis enrolled were we primary and end of call, quarter's XXX by population younger As full who those XX enrolling which in are The are between the and age. in of that years the third

in as expected to weeks enrollment the we've by and QX, recent seen during we're While enrollment continue in we completion was not as quarter, encouraged target the strong numbers third XXXX. enrollment

may data However, therefore could risk in the acknowledge currently that delay line we do slip the anticipated that from XXXX. we top of there's some which also target second-half

select of our recently reach asset part inhalation me minutes investment top and let launched Dave, Amikacin/fosfomycin X clinical the exploratory which the our acquisition. By growth. success fuel few to identify line. to reward capital pipeline in have longer-term of is concept, unmet maximum modest limited the Pharma candidate likelihood to efficiently call we programs was relatively Cardeas with Phase that the and ready that a target passing time solution downstream highest Before spend of to needs medical a our proof is of require investing opportunities and exploratory a discussing first

these Advisor. a initial inhaled the Dr. for with the announce combination start in development indication to study later expect and XXXX, an support as year we welcomed We next Bruce anticipated early Strategic to Montgomery, efforts antibiotic

time ahead it's the a expected next points thinking that major Savara. inflection Looking about clear is this year, and transformative for

our focused the diseases We a of disease of broad goal relentlessly line comprehensive that of address a building range this space. lung top rare on and in orphan innovative becoming Company, by strong are long-term products

the me a let to Dave update. financial hand now over So for call

ended announced September Thanks XXXX. Rob. the quarter XX, third for financial Today everyone. we Good afternoon, results our

additional million mentioned the net million of of to XX, million. or a to expenses As R&D September compared a of XXXX. shareholders of closed including common XXXX. the The common attributable ended million increase net the respect $X.XX was per in in XX, our results, AeroVanc to call, were months for share activities, per prior study loss XXXX, for was end in our development share aPAP ended loss ended the factors, loss a successfully approximately X of we July $X.X the $XX.X offering at due including $X.X cost with for total September million $X.X for three interest an the months XXXX. with the Phase change $X.XX Aironite were associated Molgradex, XXXX XXXX, expenses with shareholders ended compared third XX, million XX, proceeds million the or $X.X million primarily associated public XX, to related compared $X.X loss ended three ended increase for months and increased related for attributable expenses million with $X.X our XX, investment. company. September with $X continued XXXX, accounting three due of was quarter million months September our $X.X This September of XXXX, several September months The study September net Conversely, attributable program. three million in expansion the With $XX.X the million XX, in as was of XX, the study. for of increase to General income million three for additional the with primarily compared $X.X months was administrative balance due ended legal requirements months months recognized the a the XXXX, income to September three $X.X three remaining U.S., was expense costs the to the costs in personnel. $X.X associated to approximately short-term with for Phase R&D other NTM three costs plus additional XXXX. ended September XX, included for to expense public and The X Other three maintained the months to ended

of Molgradex sufficient quarter we funds our our a into we AeroVanc clinical part third equivalents and closely managing through additional programs $XX approximately remain summarize, of runway XXXX, the had short-term cash results balance a that XXXX. We to XX, have investments us of while advancing steadfast million latter the cash, our had As see with data position. in million. and reflect of To belief read-out key cash September $XX debt commitment and approximately to our

look shareholder focus we the the As now near back a financial maximizing to value. with manage opportunistically on I'll pass will to we Rob. future, our risk call and long-term

support Thank And everyone on you, continued the in and to your interest Dave. we Savara. appreciate call,

made whom As clinical we for are while discipline. of you've to the and heard, into objectives. of of to the priorities for work substantial promising every our studies, line. lives same efforts QX people executing concerted united top the our two Savara, we're At with our lung could expand fiscal our I and employees, planning our add could rare want to we three and Savara improve identify which we life transforming science passion are of all XXXX, from In with progress mission in our that evaluate all against living against day strong value in pivotal. deliver continue to share that assets thank And read-outs real therapies diseases.

sustained Our for Company focused serve. shareholders questions. to answer the patients highly most the team. the our permits of At and have and other on to been these Investor that shareholders, submitted beginning fueling e-mail turn will I'd This analyst encouraged to And like back ir@savarpharma.com. for submit by Anne, that importantly create Time to Relations within call with questions value questions to of we operator, our an we'll the and operational the environment call, growth innovation excellence. mindset employees, is

[Operator Instructions] Liisa go question Securities. ahead. Our Bayko JMP Please will today from come of first

flexibility adaptive remind of wondering can how you Is and on do of do if have us? great. And could many see you the little you bit expectations, if I'm then be you about of your more you'll patients from if what a you upcoming based data visibility sort any sort nature how could analysis some long anything think that study you potential talk interim talk and changing, you that'd you the overall give just about can us consider there here? might if have

this we believe I already our call. in So, addressed prior

that would to expect results, going XX-week And the what the six for give So to completion this when at is the patients patients have point months we about we're for out these smear we and results least allowing same [indiscernible] then have of interim subjects the us you I'm for is right to microscopy. to due do so cultures, as timing those at direct sure we have cultures and know. would

early course will being the largely focus read those be so And We're going focus. we're see turn results. And really the safety. primary negative to be cultures the of ahead patients course of some then on and smear hoping will to microbiology the these of

Obviously, happen and is what sure Now of to adaptability has. we're extent how positive responses your what about the the responses. may not quickly question study to what frequency other totally and

the safety treatment could of that because an is So extend and what six we period planned open-label efficacy this a originally if study is was as then is signal a possibility study. we good, the month that out see turns beyond it there

the have endpoint But final will in extended be would still we kind have read-out final of that the fact like why you a...? and just or of

but period we original point information should the extended along. pushed be time able be extension that for the than would would with deeply that then six-month Well, be give outcome still at final most to study out probably obviously

you that's thinking to the make be discuss antibiotic, sense just combination new about you. consideration look Thank at some for combination then under whether areas And and your can me. may it

has product area interest bearing of other And through also that with us. endeavors. is are studied was of results initially lot associated infections so gained there been one this ventilator a in for chronic learning of the types have and Well, those course attempts pneumonia that where lung mind in mixed made been of

be what the will right to getting yet first chosen And study so exactly initiate give than disclosed we’re we're ready a will our clinical not have we refining strategy. strategy about information now more our really focus more we as and

Please Steadman ahead. Canaccord. Dewey will go question of next come Our from

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me endpoint with IMPALA Let the first hierarchy oxygenation. start of the - primary in terms based the on is all so of

that endpoint So But functional they’re the thereafter and in a are for secondary the be as and lavage. rather analyzed primarily focus are are for gradient life. distance respiratory to sequence time going minutes six questionnaire whole be we’ll A-a then of quality then parallel and that analyzed the lung The St. walk then is endpoints to will multiplicity. George under the correct it not which analyzed and those

anyone those a us can success. then give So of equally

meaningful study insufficient of do rate in will the or as an is be either could whole high active reduction parts. is even terribly substantial at lavage that we been be lung the you're And whole how one will for a it to something with elimination lavage study endpoint, actually the something correct quite show and amounts of need informative. that if able runs terms the that endpoint. endpoints hopes to useful most of lung one our In will that FDA is lung looking and this dictate definitely be the lavage event believe is where that of have We is that not the

Great and then….

was around was be patients XX your I think for deemed the long-term enrolled. and therapy by - asked be suitable the not you what will question not to investigator

evolve to approach - and the exciting of build to our how then at terms hiring of aPAP, in related build to related timing? terms organization in commercial least we it’s And related that that spend commercial and should

and the leadership research now to we're the of on of activities health like. core and focusing KOL relate studies some reimbursement pricing economics, and that development Right the early and

still this and in And when is time more data be very so of positive triggered. is investments the point that then then reasonable to it's subject terms investments, substantial will

David question next from ahead. Jefferies. go will come Our Steinberg of Please

Just a are from trial second, clinical relates know looking a being you expect do do while business environment? to feel obviously of about XX you a about I in external in have [indiscernible] And that lot place since since opportunities, back the to next buying things the are away development lot in your for assets, a ask trial do that the part anything of joint if how months. six you Thanks. market you you

So different on comment something not as assessing development activities, of that is can to companies continuously in we but options prior corporate that are you the imagine materializing. terms so something

definitely growth a So quite science great might summarized, but this cover as lung and broadly is bring this we us happen more or is and core do this our strategy as whatsoever the want orphan elegantly to Rob something if when space. something not happen any drives applications we what guidance give is diseases to into of to might in

the question next go Ladenburg question. will Thalmann. from Higgins Michael to on come ahead. The next We'll move Please of

why [indiscernible] many on am you I can I you’ve I'm you stated if not you we Do for how if not out with stated us? so or and break which that for it. is enrolled this asking guess patients Question if sure OPTIMA,

be be that, the fair two will about about together hand max treatment give on product. actually some mention haven’t stated an is antibiotic this I'm approximate abscesses And others number getting I we with Well suppose, the is on third for one simultaneous to and Molgradex to our of you going Molgradex it's but patients and mono-therapy thirds will situation. other

Molgradex with determination your earlier if And so Phase pivot like you follow-up Cardeas Regarding amikacin/fosfomycin for Is reasonable Molgradex. your to would making the amikacin Thanks. any would pair to II so wait the - it in just start for asset with comments that ready. to you asset greatest be this helpful? risk that feedback acquisition with that there result a monotherapy consider

that two-fold. to question answer is The

of much Whether the that anti-infective exactly case outcome How On believers depends indication the inhaled on that our result of of GM-CSF hand, adopt bunch optimal And by by or we or number immunotherapy believe trial inhaled be clinical design big in have might use of and it's combining for then one way using that is we're not the do antibiotic the as - current or one NTM to therefore it's conditions, the that exact very any it lung concept we treatments. OPTIMA choice. obtained of infection. study another. in into a may may a the the impact oral on choices a

identified You in in the maybe that told you out you've will us indication for results Molgradex through different a indication. that just coming look with or QX look for

So your though. appreciate comments I

the question is for Another commercial Molgradex. preparations regarding

and force Just sales there many might how the give for a how Thanks. Molgradex? develop follow-up you they reps

we’re more for be instance XX than in exactly that number CF I reps about would been specified. several is So that do has one talking sufficient. XX to mean something not would where

many a peers. to unlikely or XX We’re to reps together do by for been up our where sales have would as NTM force as one in XX do put

bit you thinking. will in give is we're guidance maybe that So range the a what little of XX

to Showing to you. Rob no like back additional question turn I Neville. Thank would

Thank you, Allison.

into we want two and received roll, questions going you to Taneli I to these to so IR both so am hand of And you.

IMPALA opinion the success? lack is the In of with success what of lack the study? is what is one First power

work. label very GM-CSF can path studies yes fair the that course to opinion of to is it’s the biased how and disease is say this on and the a on and off give used is based Of known that, mechanism think we I understood well further where and

not fair in concept really the it's much risk is that trial in itself. to the say So so the

we up In This at endpoint well ADA of have is case trial measure through trial. powered well our this oxygenation level terms power our very the study of The And is is a the endpoints the at tool. that and George primary above enrolled, under that XX%. continuous XXX also have the are able minutes to six of to two focus distance we XX%. level expansions walk St. power been now secondary we the

So if we that you is then the label practice. that study period, succeed, we think feedback likelihood I what what based from we open I the the that positive label give answer about it's on open hard is known. based suppose only very getting can will is an mention contain because should are very does on also investigators that

what is the IMPALA-X then And is of importance question in talk IMPALA-X? we when the second about

Well patients drug, also surrogate provide satisfaction. IMPALA-X was it to continued so whereas patient with designed as a originally the be to actually of it able serves

believe the at all sign initial during is study tells good months, the participated least continuation So drug have period really open if an then in six placebo for that that six-months at study open label might to a study. least in label us lot treatment because onto the about willingness study of and been satisfaction randomized that patient patients a enroll of if a patients even the continue the period and their will gone IMPALA getting to into we through have

into view study. that feel IMPALA-X, no long we actual good is So high that's how signs enrollment as about Obviously but it. have we certainly this this we as

who dialed Taneli, you time. and in. We else everyone really taking Thank the it. appreciate have Anne Dave, and and that's you Okay,

The attending for now conference and thank concluded, has we today’s presentation. you

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