SVRA - Earnings call transcript Q1 2020

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Operator

Good day and 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 Web site, at savarapharma.com. This call is subject to copyright and is the property of Savara. All recordings, reproduction, and 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 and Anne like to Corporate call over turn the ma'am. Erickson, ahead, at Please would Savara. now Communications go Head Investor Relations

Anne Erickson

at first joining and afternoon A reporting our results X, today, thank of issued for XXXX, be site, quarter Good the us and Investors financial XXXX section savarapharma.com. can you press today. release earlier May was our found Web on

to the would If added you've like release me e-mail you received distribution not to company's at this or please list, be ir@savarapharma.com.

available statements the live, will This call conference on including SEC including studies, subject company's laws, will a Forms XXXX, also replay meaning uncertainties, and and securities recent the in the contain through being Thursday, and issued webcast May our call X-K, matters. X, days. and on today, goals, be available available remain is and clinical to Such statements financing May federal webcast regarding XX-Q. one statements be XX. XX are our press and within and hour the after those product telephone next risks call Today's candidates, XX-K, company's forward-looking release for site, filings the of Web A described replay will significant strategy,

performance the of as uncertainties. caution any you We which the or expectations place due and risks reliance today. indicated statements, may on of from results differ materially speak statements not Actual those by our to forward-looking forward-looking undue only to

we alongside today. that e-mail to encourage received the will We permitting; will via to the shareholders analysts' submit end call; of Time questions we've questions any these address we at questions others take ir@savarapharma.com. however

President Executive Chowdhury, are Chief Dave me and Rob Medical today Jouhikainen, Operating Officer; Financial Neville, call Officer; Joining and Officer. Officer; Taneli the Badrul Chief Lowrance, Chief Chief on

the over Rob. I'll now turn to call

Rob Neville

widespread everybody appreciate the start and commitment and that. has saying that to us the call an start I year. for strong confidence the of the that you, thank new navigate on to despite talent us waters and by COVID-XX, a enjoyed of testament these Thank joining with unchartered we've eye on my the to to wanted and future. colleagues a This is you allowed far-reaching Anne, impact this afternoon,

long While situation of no in that never and been one and reflected COVID-XX, knows focused Board our our commitment uncertainty mission, is last, patients team to Savara's up our again employees do. back the how important, alongside to the on will we Management commitment remain for more everything have

we with the minutes. X. share programs, you FDA marked our the design which of IMPALA in a regarding with a details We we've confirmatory about a discussion for will continued With Badrul believe now this study, few have

for that aligned grateful safety in of agency, a that study collaborative have the successfully design will our with feasible are we are Molgradex conversations aPAP. the nature We confident the and of evaluate on efficacy and

Additionally, new X we business. strengthened our gives to another and that expand our goal pipeline short-term the us Phase grow assets in

addition the orphan no could sought available. with bring opportunity always therapeutic of care treatment have the another Apulmiq candidate address of patients and unmet We transform develop have standard who for that our that diseases, to market we need options therapies drug for lung pipeline, to to have late-stage new a now to other

that in of at can to studies. the limitations specifically new site stopped visit these Phase with possible. fibrosis, are cystic enrolled While Due efforts telemedicine to clinical study majority the to studies to where adherence the report two we to X continue in those keep patients we've enrolling to navigate face effective. collaboration treatments companies I'm visits challenges our pandemic some guidelines, efforts through, the in made both are studies who by proving Phase X already of impacted and of been now March, been being first, are by with extent, nearly FDA COVID-XX practical To and concerns, we date, ENCORE online caused we have best AVAIL studies happy by the all research allow the and end able believe patients to and protocols. in centers,

monitoring In conduct. governing and this about regard the we bodies are continue situations to study follow closely guidance of

the the to staphylococcus study, AVAIL in Fortunately, AeroVanc aureus patients we infection. that out of and of enrolled methicillin-resistant is or patients out Enrollments our years the six completed of reached the numbers XX XX patients MRSA XXX the with in is The evaluating in close enrollment target adult population targeted analysis of age, XXX. and primary which population lung target younger XX. between

some hopeful, power. remain will have statistical we the impact enrolling fewer study's patients on While

won't estimate until However, more impact study complete. the accurate is we of a have that

those to We top line XXXX, early and sharing with data continue then. forward expect results you in look to

enrollment disappointment, nontuberculous The a clearly data exploratory COVID-XX XX of of believe for will lung due ENCORE from program, Stopping study out was was which enrolled, nearly but XX X NTM Phase total potential concerns of XX. half next patients from the Molgradex the the Optima the these and safety to a valuable infection. patients mycobacterial, will with provide we Whilst recently steps NTM information completed determine ENCORE or study. in efficacy concludes also we includes

COVID-XX that to aren't contributing report also the challenges I we against fight just that to the created, are the am has pleased we reacting to pandemic.

to with a a study will COVID-XX discussions assess is an may leading for University in respiratory in Giessen, a or serious rate. supply less The development exchange, Germany, to in potential distress multi-center study the and the high immune drug condition based on prior causes the that GM-CSF reduced system gas innate very to fatality lung mechanical has placebo-controlled belief Scientifically, ventilation. ARDS, and the investigator-initiated progression morbidity, function improved efficacy Molgradex ARDS; to are failure need We of the the of inhaled respiratory clinical for pneumonia of acute syndrome that study pneumonia. of COVID-XX stimulate preventing in

the research our exploring drugs are academic address of investigational to institutions scientific COVID which happy this to potential crisis. are We support

to not anticipated advancing are find posted. of timing pandemic. it's Because Molgradex details supplying can than completion. patients and the and execution more this of placebo, the ClinicalTrials.gov study, enrollment its combat design, of on other control on and with this once and role enrollment a we provide in to are the learning the additional knowledge results or Alongside the details and therefore is play a in You this we matching to healthcare forward exploratory information Savara-sponsored community, not study, research on cannot criteria, needed help look other proud

priorities, we'll X Phase our year advancing main busy our focus Looking on which forward, are we have and an exciting programs. planned,

a are position deliver to execute adequately are our and We in cash strong and growth. believe strategy long-term we resourced

back hand the on key to update R&D Badrul, who now our With will for XXXX. priorities you that, I'll call

Badrul Chowdhury

with Thank be lead direction remains you, Rob, is in for again. clear. Molgradex nice program, and speaking our you hello The to everyone. It aPAP

priority FDA, one report understanding now number the study is to with we plans have that, design. am discussions a X Our for finalize to good the IMPALA following I X. pleased of IMPALA

compared administered Molgradex to with micrograms be two a arms, XXX expect We double-blind placebo-controlled placebo. to daily XX-week once study it

a diffusing three SGRQ will endpoints which endpoint and be in test. endpoints three using good gas The the St. SGRQ combines are DLCO Those treadmill believe secondary benefit. between and the component in a Questionnaire which secondary IMPALA placebo and a that will monoxide score X. by for components, endpoint DLCO, all Respiratory SGRQ, a capacity capacity or study, has the that SGRQ lung SGRQ in direct test are carbon IMPALA The George's drug separation including of primary is supported activity nice total showed activity exchange and impact. a serve patient three symptoms, key endpoint function measure we that and IMPALA was score or as measure effect. demonstrated exercise total

most separated in worked as For out IMPALA. activity, IMPALA is X, to and applicable SGRQ also we well aPAP it

effect this the be is as The of the as safety reason of well chronically. the be help this us endpoints assessed intended While high at study administered to of will is the be IMPALA long-term the treatment X. better XX of will to At week a which XX the drug XX for the level, support primary because durability is design week treatment weeks. for duration efficacy analysis, placebo-controlled will

determined has been protocol and be well final as the updating is work please the advised the or size. sample the to study you as timing, including start we forward protocol being you through as look additional still However, finalized, Once the details the of study. study, that, on details of

possible believe team aPAP. excited clinical to of order and we're meantime, be study a now they're clinical the completed soon the will internal up as running potential initiate of in work hard the to that following get Molgradex that protocol. can progress, study also the finalization of by contributions In appreciative very activities and insightful confirm operational the experts. as treat We're and to our of we the And anxious external this initiating

a specialized like when global I'd develop the attention for the inhaled targeting treatment medical of there particularly substantial compelling investigational This pipeline rights we commercialize and to late X program your orphan to unmet investigational gears Now, diseases, or need. drugs, well with stage our newest lung ciprofloxacin, as of March, obtained fits to turn is NCFB. inhaled late is shift and program. In and evaluated non-cystic Phase Apulmiq, our fibrosis bronchiectasis

could for medical problem. to sick can a more represent patients productive late and inflammation, it in cycle infection, damage. blockbuster than program to experience opportunity We're pharmaceutical NCFB other excited cough, vicious believe is for NCFB and hospitalizations. disease of U.S., lead daily approved available by With with stage a can very development a potential which nice no is structural exacerbations and compliment a about our the characterized Apulmig and programs. sputum treatment Savara. XXX,XXX growing lung of this the options The are Patients is

approved believe important to is drug this Phase us we development us, devastating confirmatory called total attractive guide ORBIT-X, disease drug Apulmig The one because in in ORBIT-X for the have for advancing of no was placebo. yielded the information, Apulmig wealth candidates and essentially clinical program and with medicines, two XXX studies there a to study. especially are the evaluated continue patients and of was efforts disease. to previous future provided randomized for two difficult, Managing X its a given it's and

with treatment did these studies, was a statistical placebo and On the missed the statistically in difference in time which to in marginally analysis result ORBIT-X. exacerbation, significant for not specified on Apulmiq protocol endpoint significance primary ORBIT-X, two from first

owned re-adjudication process third-party the with evaluation AeroVanc, agreed previously difference the exacerbation. of Subsequently, after exacerbation show significant statically statistical pulmonary an events. upon significance. following first showed for did ORBIT-X a a who the to re-review independent concluded that and data the an However, time program company provided the FDA, ORBIT-X of also

exacerbations, of the ORBIT-X. separation between frequency With drug robust regard demonstrated placebo a effect endpoint, to an both in seen with and studies important secondary was in

For in NCNP Pseudomonas the demonstrated and studies, considered aeruginosa poorly was bacterial a as used showed antibiotic inhaled which and airways. favorably, the can for was efficacy treat both off-label to studies, cause currently load, tightening key there Apulmiq which ORBIT many important and measure in in safe is well-tolerated is antibiotics tolerated, effect, benefit are the

Based approval our on as well between which in studies, the be discussions verify U.S. will as will and of and ORBIT study successful required results ARM believe confirmatory the for that we own FDA, the one we assessment, the with the FDA,

program, well from learned of patients as study as design. the frequency provide primary endpoint, with can We number studies ORBIT with as of knowledge exacerbation. applied us previous us a of historically exacerbations, that valuable data rather antibiotics from first development the the lot such be than the to high using exacerbation future next inhaled to and allow previous other developing that Extensive optimize studies, to programs will as time enrolling have

is will accounted parameters and our discuss we take it of some It time for multiple FDA This confirmatory right. will a Operationally, regulatory study. next speaking get ensure interactions. steps to with to involve a process, the

As progresses decisions and communicate made key will with you. are we finalized,

can we execute our imagine tell our exciting organization. you to plans maturity procedures a to of have Phase on year. have work manage, implementing that productive to programs and a within we ahead. to to can core and expertise X XXXX do, ensure R&D I the lot and times As be additional ensure our important processes three to with you operational

Dave, provide call now over financial who you will the with update. I will to turn the

Dave Lowrance

everyone. I'll on our you and by hello Badrul, updating position. Thanks, cash start

financing, capital short-term including million and XXXX. March of $XX As tranche cash approximately of million, with had we we second Under $XXX well of XXXX, sufficient XX, equivalents, December to cash, operations have investments we the current million our our into anticipated believe debt. fund $XX operating approximately from of plan, planned

compared million the and XX, with rights ended development $XX or to the of development upfront million share ended results, three acquisition respectively. the months net three and XXXX, March $X.XX March months Research XX, increase by months for With in XXXX. offset $X.X partially development amount was to respect was for $X.X million with loss was compared This March to The our a licensing the costs the and per million for ended or per due expense three $XX.X of share, related March ended commercialization $XX.X $XX.X license $X.X AeroVanc to million million the million XX, Apulmiq. loss quarterly expenses of associated three Molgradex and net for were decreased $X.XX Savara's XXXX. XXXX, with the XX, months

$X.X March increase ended XX months for were XXXX. corporate due to $X primarily with was XX administrative compared compensation expenses XXXX charges, based personnel ended three the and insurance three months million, The non-cash costs. stock for costs, million General the and March

my reiterating by conclude position I'll that us remarks and to deliver growth. our long-term execute enables strategy cash our

I'll Rob. call hand Now back the to

Rob Neville

you to thank any to you earlier. programs. summary, wanted is that Savara one leave thought you, is not and In just Badrul by our with Dave, Thank defined and of one I

is disease of components orphan company, targeting the the drug focus required pipeline become strengthening and Our to including lung respiratory development rare diseases. of multiple a the gathering candidates diverse in

vision three take hands execute far would more in we late and process to the our and getting beyond operational to shape, than processes of about to this committed That flawlessly. market I be quicker the development ever would place we continue strategy I'm love see to ensuring patients. what Well, into drugs the and programs, is XXXX all excellence, right to stage drug than be have

continued for Operator and We do the I open thank your to the you for support, questions. ask all will analysts' call

Operator

you. Thank

come Instructions] We from first ahead. with will now begin Please will question And Higgins the our go session. [Operator Ladenburg. question-and-answer Michael

Edward Marks

questions. is This afternoon. appreciate Good you Edward on I the taking Michael. for Marks guys

quick initiate ones what from discussions NCFB two with on looking for wondering FDA you're that Just the the program trial? the me, as the timing to

Taneli Jouhikainen

is this Hello, Yes. Taneli.

to but discussion do be given that exactly when be expecting cannot to fact will we during several as give this outcomes. as We priority the to guidance there a will report interactions, able be we year, may really this specific clear

Edward Marks

with was any remarks could just about And then first Okay, prepared trial provided talk about design isn't the the the are in this that thanks. XXX% looking if changes, the at yet, trial? X, how caveat being made IMPALA solidified IMPALA I'm in that you wondering any versus if

Taneli Jouhikainen

please ahead you with could Badrul, that? go

Badrul Chowdhury

not in couple of is Sure. highlights was differences dropped. highlights the but trials the point to are IMPALA, which are would dosing, Broadly I like dosing There's similar. continuous The which was out. as intermittent the robust, of being

which treatment a treatment DLCO, two will a is IMPALA and be months. for gradient, measure which measure. X. The the a gas The will endpoint is arms: dosing primary for X was the The IMPALA IMPALA exchange placebo. was endpoint also or exchange primary six period placebo-controlled the IMPALA have So, continuous gas

X, treatment IMPALA period will XX the placebo-controlled be weeks. For the

high So, differences. these are Thank the level you.

Edward Marks

That's you. appreciate all for Thank it. I me.

Operator

I will go the over now ahead. Anne turn Erickson. to call Please

Anne Erickson

few questions a gotten in email. We've by

just first one. read through I'll So, the

conduct? or COVID-XX will is, one IMPALA impacts the study X of start the the start First

Rob Neville

pandemic allow options the terms get and year less really the why we and make in topic providers, of also we is to having the know back accordingly COVID-proof then have or expect the that second for the study progresses what coronavirus possible, is designing really this planning instance, of as we as participation year, as of it as clarity endpoints frequent visits This that, later the on include in possibility is more as to will of if would, Well, months, our the course, but early much assessment which can. close wave a probably in hopefully to of in hospitals a there right with coming to little more study normal that not, know now, again, on too said continues. things to progression care and so, as need much

Anne Erickson

Chuck, back to you. Thank you.

Operator

Thank you.

Jefferies. come Suji with Our go Jeong from ahead. next question Please will

Suji Jeong

Hi, taking thanks for question. my

the IMPALA one aPAP. X I study about study So, question -- IMPALA for have X

So Have to the different is E.U.? for you going be about trial design the had any EMA? discussions guys Thank design with you. the

Badrul Chowdhury

across Conceptually, the to world, IMPALA the unlikely different because Badrul. EMA. was trail same design is including be

we you. Thank regulatory will and to with up interaction you other as protocol. the once back far have bodies we get those have firmed As interactions

Suji Jeong

Great, thanks. Bye.

Operator

ahead. JMP come with Our Securities. go Bayko next question Please will Liisa from

Liisa Bayko

talk for study? patient PAP what be you. thanks selection maybe honing taking the you'll of the about Hi, and for patients you bit kinds specifically little question. Can a on Thank

Badrul Chowdhury

study. which they The justify we the Those diagnosis patients they being impaired be to room this primary now. they can broad to a right in Thank would enroll antibody have is will look got at share DLCO have have autoimmune have the also and so for sense, is have you. and the on would the the IMPALA that will, similar are DLCO, to a PAP, who designation, endpoint are PAP, patients so to which autoimmune Meaning highlights improvement. the of we obviously,

Operator

the questions. back for Anne pass to Erickson any call will I additional

Anne Erickson

you. received Thank over We've two more email.

enough have get study? you cash the IMPALA X do is one first The to through

Rob Neville

factors So of are include well. size there're still pandemic of that the the and as to going study, going our effects to timelines several impact open that's the

the on study working better those selection and we'll protocol have all Once study timelines. by known be agreements. arrangements, CRO able currently practical CRO and we to including factors have our we're to estimates finalize June So the all

Anne Erickson

Can about? on what us that question is, in next you're specifically you The you operational tell thanks. efforts. mentioned came maturity Okay, talking

Rob Neville

Phase to is we well does and mean as the require as our studies in all that external of what of X study as, vendors that that well possible processes, highest quality internal execution ensure oversight. Yes, we robust as well get successful very defined of with robust course, topnotch activities, study so

lot putting anything also studies to have our order as focus forward. in is success the and While in Savara are in probability improvements a a of going of this strengthening implementing we resources highest new, operations, our our not now in to effort

Anne Erickson

Phase get is capital Okay, came in, and you it have thanks. the through I'm Apulmiq sorry, more Apulmiq to program. study? the one Do question around enough X

Rob Neville

So and start X priority activities, is our IMPALA ORBIT-X, not currently that study, and fully that for FDA to it's and with saying just Savara, funded. calling the by expect -- and the on resources to the a Apulmiq, it. have to We are to other bolt-on as first initial program. is me which hand, though negotiations let get the cash allocated the resources are prep the we do necessary work through the all the

determine then However, initiating resources study will prior how needed that are best to what to we it. fund and

Anne Erickson

of you. was email. questions thank came end the That Okay, that over the in

this everybody dialing conclusion is for you So, Thank in. of call. the the

Rob Neville

Stay Thank safe. you.

Operator

has attending presentation. for conference now concluded. The Thank today's you

may You disconnect. now

Savara (SVRA) 7 May 202020 Q1 Earnings call transcript