Athersys, Inc / New (ATHXQ) 7 May 202020 Q1 Earnings call transcript

Ladies and gentlemen, thank you for standing by, and welcome to the Athersys’ First Quarter 2020 Results Conference Call. At this time all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions]

I would now like to hand the conference over to your speaker today, Karen Hunady. you. Thank ahead. go Please

and everyone. Kasie, good you, afternoon, Thank

As Communications Thank and I’m Karen you of Corporate Hunady, Director Investor joining call. Kasie today’s mentioned, for Relations for Athersys.

release a If not on the athersys.com. market, copy issued at available at website of it you is the have the do Athersys’ of close press

Gil is be and Chairman Chief Officer, will Financial Ivor provide with Bokkelen, Macleod, Officer Chief the Van us our corporate update. providing to here financial update and Executive

and last the the to section. of XX our expected a is press minutes available after webcast information replay audio XX hours website call today’s in call’s release. be will for Today's also The access Events the to on is under two the conclusion

prospects provision statements Safe public our XXXX. statements Any from of XX-K result indicated SEC the the constitute under Actual purposes in materially those remarks Reform XX-Q, the those including we plans by forward-looking results make that other for Act Harbor may and discussed forms Securities about Private of factors, forward-looking Litigation future differ various filings. of important a may and as expectations,

We developments subsequent events our cause to that may change. anticipate outlook and

disclaim may so. the forward-looking point those While future, to to obligation statements some we at elect we update specifically any do in

we the reference then, SEC and please was may the who recent so have held to For benefit announcements topics X, may most call discussed, Since those made to replay, press and May filings. this of be listening XXXX. recorded the our on releases related

Ivor? call to Macleod. to the turn that, like over I’d With Ivor

March it my of Ivor I an you of for everybody. pleasure joining Karen. Officer to thank the call. is again give and Financial Chief afternoon you Good Thanks, Athersys Macleod, am I first once overview today's March XXXX ended did the of the for XXXX. ended to for revenue recognize not the results three compared $X.X months XX, three XX, for months We million any XXXX. financial quarter

with services manufacturing into in collaboration time from the vary to Healios collaborations. our other collaboration revenues services Healios expect perform period to enter with were or actually related performed. manufacturing in prior we We potentially new generated to revenues over contract our and do The activities as engage

increases expenditures the $XXX,XXX in internal expended comparable development costs $XXX,XXX, is The million $XX.X $XXX,XXX the consulting in costs compensation XXXX services over of costs of period $XXX,XXX, personnel research of costs $XXX,XXX, increase and were stock supplies other associated first and million $XXX,XXX, of with a $XX.X in of $XXX,XXX, of and of the quarter Research XXXX. development $XXX,XXX. for increase research outside

decreases of manufacturing increases clinical these partially development and by in process trial costs offset With $XXX,XXX.

Our clinical stage on expect trials and development, clinical clinical timing to to XXXX our and clinical of compared based manufacturing process XXXX. projects. of vary manufacturing expenses We manufacturing campaigns the for time underway, costs increase annual development development manufacturing trials as do clinical development process over

stock compensation and the General March to months The outside compared in services, three personnel costs. primarily the administrative due in period to increase for was and comparable $XXX,XXX million increased ended $XXX,XXX XXXX. expenses increase an XX, $X.X million of were costs, $X.X XXXX,

a Our a is quarter The of of net compared million first million previously loss consequence $XX XXXX for the the XXXX. difference quarter to net the mentioned $XX.X of was first of in variances. loss

were Healios nor approximately proceeds $XX.X connection warrant include public is at months offering, XX, December March our XXXX to $X.X March It March that cash ended of not had with operating $X in does the At important in cash income XX, cash recent $XX XXXX. does March the and XXXX million compared the note months XXXX. exercise equivalents activities which million XX, in of cash in cash to three our balance receipt million equivalents the ended was million compared $XX.X During XX, we million three $XX.X XXXX, net to XX, and million used gross. it the

Before I the Gil, the Coronavirus Based Paycheck the and participation U.S. the Athersys did Economic Aid I established million. a for initial by Relief the Protection in ACT address Program, Department applied the of business loan and of Athersys approved met guidance to Act. of Security want as call issued to CARES Treasury, part was over a the turn on the for and qualifying of the criteria $X.X PPP,

may the not loans. of Treasury guidance for approval PPP public that the Department the issued loan, be Following revised indicating eligible companies

As did and million the not Administration. the proceeds Business returned $X.X we a loan accept Small consequence were the to

to for will call I Gil? that, Gil turn update. the corporate With over the

world last mid seven At in March, globally held our Since meaningful there cases some in Ivor. confirmed earnings has only deaths. and call, confirmed XXX,XXX COVID-XX approximately that infection were patient XXXX time, the Thanks changed ways. weeks and ago, of unfortunate

confirmed here cases As of there and more includes million X.XX infection been COVID-XX of today, than cases XX,XXX deaths million approximately This United in States. and patient have deaths patient $X.XX have confirmed occurred globally. XXX,XXX the approximately

roughly or Among the XX,XXX rate successfully about is and currently that patients mortality Among represents active the ill has resolved patient with million X.X active patient approximately cases the infection. either recovered X% died, infection number patients the and/or approximately the which or discharged is XX%. hospital COVID-XX been fully the cases from cumulative of where has globally, the critically confirmed seriously of of million are X.XX

economy the outbreak. and impacted or many spread closures operational This schools the mitigation home businesses, travel people shelter-in-place restrictions, from in These include the prior and and implemented designed our limitations of public work internationally, unimaginable the facilities, slow here lives implementation that mandatory strategies regional to and national policies, and U.S. significant to of of have has were national to infection. ways in Both governments organizations. other

of problem time the this is that cost come The COVID-XX individuals and that successful mitigation deployment away to pandemic. significant diagnostics, novel vaccines strategy the is has the widespread a intensity impact But this ill. going will or families. virus many antiviral protect not accurate It devastating effective seriously any therapies of and severity to enabling of treatments the rely has fast and against the slowed lessen resolution have of appeared at Ultimately, do spread clear critically to and treatment of patients also the everyone soon. to that and people and infection, containment development become and on

of these represents a defense Each critical the the virus. line in against

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will a patients seriously Athersys difference. or where believe still critically we die. That's can Some ill make become unfortunately and some will

patients that focus threatening current treating critically and other following on is or become have ill and experiencing complications. infection life Our COVID-XX seriously are that ARDS

days, our ill ventilated We severely that the patients ICU that from achieve life from experience patients provided pulmonary clinical being work patients first the reduce evidence within more meaningfully days our are administration of free experiencing independence, mortality the few prior in help ventilator following of increase ventilator might especially quality achieve informed by function ARDS hospital. of MultiStem discharge better free and days and improve

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the for call, as a earnings the we that for with in on therapy MultiStem Biomedical as Development As results BARDA Authority began focused last patients late we January or a experiencing Research announced using ARDS and of Advanced the COVID-XX. dialogue a in was potential

for several there pulmonary including described leadership As recognized among available and is effective and primary dysfunction severe patients appreciated is of it points, that currently the and from we have treatment no BARDA inflammation. mortality that key previously, suffering cause ARDS one,

relevant acts and traditional viral situations mechanisms emerge potential pathogen might not severe or the in MultiStem through new action specific act where Two, acts cell that virus biologic of it of ARDS, in or that to action. contrast and mechanism that single a inflammation three, is that are therapy be that the mechanisms therefore living pulmonary broadly pathogen cause multiple and has to a through through MultiStem pharmaceuticals or outbreaks

details a the our provide and for We are provide that process and but relating time days actively initial development present ongoing to is were to task BARDA being. and budget. certain is In remain our we ultimately we proposed subject path, laid to watch to invited key that proposal or and process additional comments then followed weeks discussions corona further this as BARDA to unable submit engaged, other restrictions information, we with the out until are completed, the force, the activities

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clinical authorization request sites span a received submitted for In for responded patients for to of trial the approval, FDA first designed into to we successfully a only review, their for the the trial, information, and study, screened IRB few the launched comments the enrolled it and the FDA the initial weeks study, questions, study. obtained additional

which this lockdown many statewide during effect of was and a achieved was remotely. employees All of our while worked in

very get is and the the and making make technology am to are I obstacles It individuals everyone important for also during remained helping this that that it done contribution recognize regarding and of responsible we can we immensely to enormous overcame in pandemic. We this our potential for proud team patients optimistic happen.

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advanced also ongoing the further MultiStem We potential advance indications in geographies jointly to regarding other development with working our key commercialization discussions of and of partners in interest.

our also through financial happened In events addition, we key two recently. strengthened This meaningfully position.

decision first additional by in million The in warrant our partner proceeds more the X stock Ivor fully Healios an $X was of million shares as purchase described. exercise to than resulting to their

initiatives we beyond the we $XX put a through sheet ability programs us million on and stable second resulted gross of and advance The with financing completed milestones. of completion proceeds have we Upon important the in the to These and that debt. not financing balance further was the financial approximately and in million. events and solid in April, recently $XX.X had key position operate

and in focus importance our difficult States is and it never and this to across devastating technology economically. and operating uncertainty and and our In commitment and the of the remains the around what impact we has world, the had clinically the our of closing, Despite a that reinforces the have are our there providers pandemic question potential we The as a doing. environment ever. But wavered on key all that and exceedingly committed service for other of strong us, many chaos, our ways in belief obstacles, as individuals, challenging collaborators, rely everyone, with work is on. many and institutions businesses, including United families, no

we our challenging and very a done think things know in shows to how even January since progress and chaotic get I that difficult circumstances. unusual environment

substantial to as value patients delivering commitment shareholders to areas our of strong Our in substantial remained as medical helping unmet to ever. need and

a develop joined Before help recent Senior Maia experience us continue executive March potential to commercial needs the I'm strategic & of the most in her recent implement organizational Partnering commercialization will on addressing questions, McKinsey as as product. and executive supply members introduce Maia MultiStem decades her our I management. a Hansen. continue to and advance operations, a of with establish, few move addition planning brings capabilities team, Maia in from chain at pleased and with we Maia to of team, Company. us other to to towards Partner the role Athersys

briefly I'd And like Maia? that, with to introduce have Maia herself.

and Gil everyone. afternoon Thanks good

I and Athersys Supply that. this I mentioned, team and an year of know company to in company get be the well I'm long-term Chain. opportunity Operations President mid-March understanding Gil as the develop of Athersys leadership to excited Senior the As and joined of the joining had of Vice quite of now objectives to part members vision and team Prior very to

Prior several life with Cleveland McKinsey's companies Director. Senior Company. practice the Partner I building global at and pharma companies, as I worked molecule major the at important companies, a roles large particular and McKinsey, operations OTC Over on science and XX distributors, joining Athersys, leading focus leadership across others. office and I Managing & to was including years McKinsey industries a played small manufacturers

My growth Navy The years the culture in in and is of background capabilities. to to reasons. an I'm point before as and talented McKinsey focused leadership its an team join for world. on building is at an the company background several and engineering strong set The includes and therapies and educational patients around meaningful a clinicians lasting excited are in and important officer Athersys four the business.

time commercial building readiness Over to forward that successful experience and end I to In data have is prepare quality, growth. the to sourcing, efficient supply other broadened advancement help of team my a members management, commercial the first supply clinical look weeks job working scale to us trials and and for I chain support the end and on with high and my of flexible. subsequent chain analytics manufacturing with

part today. with and am call to on again, the to be be delighted of Once I Athersys you

questions first like and Maia. a analysts up And Thanks open institutions. other to that questions we from were we would it address by for before with submitted that, few shareholders the

set it People BARDA relate long still are be first take? status Do whether discussions BARDA. filing. this we questions how of that we we will The and successful our believe effort will to with in ongoing asked have What the is? pursuing

earlier further I've are most my engaged to comments, already addressed of for actively we clear, now. but we BARDA unable just but with to optimistic, these still are in and provide comments we be remain

for on from cell relates development companies question next The other activity or and even COVID-XX to complications, recent anti-inflammatories, of focused including therapies therapy developing antivirals, those innovative treating other companies.

and While never results the we new and closely monitor a range of including other them. initiatives, trials, we probably on companies emergence from data comment of

double-blind, therapy that of a regulatory way make use or for other reliable instead it to cases. the just effectively Unlike and others placebo is few This to potential administration compassionate hype properly Instead treatments. to designed we from all don't are of comment committed most potential use available on evaluate need approval observations randomized, trials. the it conducting we compassionate FDA appropriate and controlled or may

We in as potentially patients potential COVID-XX well. believe with and our other technology has complications addressing unique induced ARDS relevance and

that commercially ability MultiStem off advantages shelf as scalability believe also the ultimate cell hospitals around and the an to and to have patients important world. deliver our therapy We and we

that double-blind, randomized, placebo controlled As has we proper MultiStem. committed clinical for ARDS from also safety the are to that further we've of therapy described, a therapy are cell data Fast the FDA conducting from already Designation only of treating evaluate and clinical trials the company has the for tolerability the And ARDS. and only to we effectiveness, cell treatment company Track trial,

enrollment ongoing in received The patients be trial. the our asked, have that patients next have other eligibility for MACOVIA has treatments People do with eligible trial. our will of question to for

study If for they them enrolled precludes another trial, from another clinical patients participating in that will not in be in study. eligible are inclusion our

patient received that under were standard prevent or these However, have treatments care treated treatments disease have patients that including not progression participate. is that and other of been that use or compassionate completed and to and would discontinued, did treatments If basis. certain inclusion requires diagnosed on they ARDS, administered be exclusion our criteria, with meets a be the might ventilation, subsequently eligible

role play our to patients can deteriorate ventilator of standard that top that and care, MultiStem It we that unique continue that belief on belief a may be administered is and treating our in from support. seriously require critically have reflects which patients essential become of or reflects COVID-XX, ill or become seriously This ill. also when critically

timelines. Other about will specifically the disruptions disruptions in asked people trials study like clinical impact our of have our at ongoing MASTERS-X, effect operational hospitals participating these

It's been of clear companies study adjustments in light have pragmatic pandemic. sites companies the allowing been very make challenging in. and of that in that FDA and The has recognized clinical implemented they disrupted the circumstances hospitals about to operating are operational and by patients many this, have hospitals, staff, COVID-XX the participating constraints light

recognize completing our possible, step things study remain accordingly, our are should or limiting to and too But in restrictions elsewhere, are understandable. sometime as We quickly precise to enrollment to expect many and this timeline say return clinical participation at people of enroll the still taking enrollment can't that's sites current We we and trial will of give it's sites hospital or Strokes to we're a happening as trials committed at light continue or clinical and MASTERS-X activity operational complete the a all a early patient. environment point, estimate. next study that in normal time. of That year. and when in the one it environment

it open questions for up few a additional to others. like and we'd that, With from analysts

SMBC question Your here from [indiscernible] Nikko comes Securities. ahead. go you. Please Thank Instructions] [Operator first

Your now open. line is

the on progress. Congrats

I first have one of here. will follow-ups couple So a and

X cohort to was done as more do and trial at dose label in XX bit hours you does post ARDS COVID-XX and on Phase assess little for trial? a safety the So the difficulty] the X ARDS plan could color provide [technical safety you open

of in population the point. we've clinical distinctive to we've something that this is so two looked trials safety we've COVID-XX initial patient study Yes, And essentially cohorts numerous dosing small this at the represent in because specifically that designed the part up conducted confirm done this to patients are never that previously.

the So patients And first if that to cohorts looking the these DSMB reviews in the two it's safety large there, the from thing. controlled then they dose do move study, they placebo which you different initial blind at each double several randomized, the we're cohort, to the the the at. of pivotal after into will study. cohort, is on second levels confirm two body And progress we of same data, just main

will over the looking at that the we And one at terms also in things as we part safety as the the looking primary of acute same follow up. be of duration of at well assessment looked year clinical previously and

applying we've same looked rationale, again, framework the at analytical So previously. that same the

okay, clarification. Oh thanks for the

placebo the aside So, there to any other of that factors cohort, safety from start part for Like trial? control like things? other that we gating wait is

We for wouldn't be to required wait anything else.

doing is into to all we would perspective, essentially basically - a the regulatory before would complete body move need completing cohorts the of it that those main from those two So first we study.

Okay, okay helpful. great. That's

like So like their a COVID-XX, comments I if any are where site some patient? in trials about trial here, concerns active what would got the on avoid you out with rolling this last own a for competing as one about there your is competitor ARDS

a so good question. Yes, that's

out going on patients lot focused is now there there activity a clinical COVID-XX. So on treating trial obviously, of right with

they for serious, be hospitalized, getting that on requirement be forms they're other patients are are ventilated. are of necessarily trials are are that might yet There they are a that not of but focused not that it's these not again, Some considered support. ventilator, patients yet, but other on they a

out is, a things for recognize patients trials off, the right accommodate that important of think that is of of ongoing. that there number first people is lot are to can one meaningful I And there So now. sick a actively

evidence the from been I think participate sites people in with to seen data to that for understand thing our power how want by completed, is other and that clinical of because study and requests The from impact generated showed the that is that which biomarker we Phase important inundated we've our they've of we study, we've supported data exploratory consistent X we is that safety the benefit, generated. compelling the clinical

moved first lot that quickly of of terms participate of and process at kind active the step in the there sites trial. want an So our I a get We're sites at obviously, describing up in take time we're incredibly of to interest the was running. kind one part the process to now, sites And as from it is we're beginning to that we've earlier and in with, with there. working continue a of additional we of

competition ongoing we activity think a strong where I'm about respect to out position both we from commercially, I I trials. not suit. be what but from also achieve scalability but terribly will that's concerned There think our like other with other there, can can be perspective our therapeutically, and I

world. make haven't frankly, way. as that face that at have against we've are executing for, challenges terms the And of terms thought around think very past, in they about they really think or And as other have of some to about As plan in and your the consistent in have of we've technology about so out the thing things that lot why a Maia, some manner exciting us now think an to planning is excited really Maia revolves don’t talked we've a so there but the they're a of about it's something being why that words cusp of Ivor the going I one we've been mouth deliver same I able in folks really could because CP transition. that us talked [ph] to joining and the was in the Maia, even hospitals scalable scalable, want reasons that technology one of are the this to been whether of begun of other developing, things, think the around this ahead other puts see delivering for robust we end-to-end that I I put is to that through, in of reasons we and to

Okay, great, great. Thanks for that.

I [ph]. it. Tom Thanks, appreciate

of comes Dawson with from next line Jason go Your Kolbert ahead. question the James. Please

is line now open. Your

must feel lot great good Thanks, It like looks of in to the raise. have cash Gil. Congratulations, bank. a a

were in look and the a trial they of towards both questions Japan. versus in also a transition what U.S. talk they what medicine, and is to One the get have questions little can and involved bunch you about there the Talking you around regenerative the ARDS different. in the bit raise, would be I we versus about is, ARDS, ask as a of different bit COVID-XX, what prior institutions on both way little saw mechanistically might very treating COVID patients, while the like

give there start Let's I'll follow-up. a you and

Yes.

did good previous have glad see So we positions some financing quality and current high positions the the in to we on either the that the stock had that. in first question, institutions, with see some or participation stock in very were

and is a chaos, window, degree, front. there smoothly. During certain on even to still of it's that chaotic And financing lot circumstances, of lot true think market those under and process, particular a that challenging exceedingly very a the went I the and uncertainty

backdrop, certain if have you things. done on worked all done, front. we to this But to institutions it and add and of anything actually to circumstances. team and the certain Ivor under how all the together achieve the get worked it got pretty pragmatic some that the flexible that Now, unusual transaction we and had with that obviously, pretty with and challenges the satisfied with be things I'm offer about we

No.

Sorry.

I echo. Yes, got your

ahead please. Okay, I apologize. Go

understand than circumstances, I very it seemed some other fundamental much like very, difficult more but raise of it's raise a I've the seen.

in transition that Maybe is from medicine in regenerative a industries sense is to space. at many my sectors, and regenerative maybe accelerating COVID working home, things so And and is the there occurring many medicine.

And that a maybe guess bit we're the test a that of raise And in transition. litmus seeing that's is good… I so, little a

Yes.

Thank you.

Sorry.

about No, you're no, right that. I think

applies little there an but is and think but I a that. think to doing think Athersys, do I bit relates specifically more important it broadly what it at we're I inflection, than

difficult in time a are companies also and I'll that quite be some would just Now, there's like are able of getting going that. able know few to that capital out raise probably, the there of really that it point to there do left aren't mean, lot are and I I wake to soon. a there any to out be companies circumstances

now situation the been do what back we of the capabilities and we position, upon ever that been a are team I the to the the about it's on. hold tremendously that been, the certainly the to things that the a things other and of throughout completion just both to as is, leadership do think terms can one organization we raise the talent some think stronger have. are able position strong And operational from the stronger that in do. off excited about the able and ever resources From perspective, as be commitment to have or first we've I is from of nice but people in, we've we a financial things than of we an in have

was raise said, answer from would and wait of tangibly how that, working in to and in with. to support, all for to other want now? that didn't things is our so short we've you are quite fact, got some efforts have accelerate who we against let discussions discussions can for money about have clock questions that it really others to that the engaged really we're they Why? done Well, a could move We we're more important of basically important while that efficiently do the in or partners be few And important, why and people us get the that institutions continuing with areas us.

nail the hit Now you on head. the

year you and penetration rather things Your runway aggressive do and market two changes than ability a vary all position capital that the to partnership to gives much want of that assure the you see, of to partner years we'd with from an terms a dramatically, strength worth weakness.

very So ARDS and I sharp increase all happening see what's regenerative sense. look think me among at interesting total a I I think because it's in and in makes players. to valuation the medicine that in also I

I think on course, very, is it patients. that's where why important And into a comorbidities a bring the of but they're what you, to position I'm also believer, that's among And that these ventilator. a may so here of different temporary. becomes sets very have the patients effect critically hiccupped raise but I see see

So reduce clearing ventilator, getting I you going have flooded storm, with cytokine a steroids, a little the I they're the about, a bit virus. lungs. in patient, can could they're a inflammation, their them I on If not through I'm smash talk but they're

is MultiStem versus belt patients, but lungs killing that the different address clearance? the So viral with these mechanistically tool inflammatory are without interfering in to and in why my response specifically

Yes, question. a it's great

and there's the administration in things you immunosuppressive of kind or blunt will, to layers of kind off, multiple but of some have worse. meaningfully fact So, not steroids instruments in other and answer worked, making first so if cases the are

not are complexity these One things dialing causing we these other that is overload inflammatory also just what's about But lungs. of and know the down in the a they're that the the cells, stimulating reparative dysfunction MultiStem on bit That's their are nature. that which key severe mechanisms is in hyper patients. the in cascade, cells

to cell non-inflammatory other and immune integrity or restore types stimulate the clean that's So structural to that for macrophages help cells the we know compromised, tissue restore up damage, that system. balance these example, the been

need in their otherwise the are really dialing So own. bad disease down process of it's and that earlier things the the up on wouldn't dialing more things that happen we that

things traditional that makes be pharmaceuticals that mentioned looked corticosteroids fundamentally would other from – you people have at. or different it And or

can then One, even a And approaches are said, so, in I they as blunt that things. couple I and type is think what we've counterproductive be not important effective. instrument can harmful some And the they cases. realized really of

really thing different more that's of other the there's more about being by the But evidence virus. interesting are a is caused that of and range complications types

pulmonary are fact a things of not about downstream in which impact is some cascade today and to was the of good lot Street Journal but system, that pointed length, Wall there driving the this article at of clearly other In the talked a only really the that happening. the things, on

average are leading activity and strokes things see on. going patients in body we example, So to these or for microemboli that other that's

pharmaceutical a traditional pick for evidence that on IL-X actually example, that's balance with it's dimensional have multi needed and or to And solution. may one that a the say but be. or these that in that something help, Those thing the but to things comprehensive where specific I'm way. doing MultiStem, a IL-X, not like can effective, it, cells way trying not or thing we It's not provide would an shows going is they're inhibitor cytokine interesting meaningful then just restore inhibitor

think of multidimensional here, the this, and I that this important, that you to situations help the I'm you because fast, do just the cell pointed where effect you and critical distinctive than and more preaching these need of thing. critically thing is cell choir and therapy care for where know therapies in you've particularly And I one types to makes to about written specific years, want

why are going data And one support, we clinical of including reasons terribly and things. of And in data where lot about that's evidence lot biomarker all position those think administer they're future. that we So, achieving so far not the we that when be a lot to mechanistic optimistic confident, and that a of and of we're we off MultiStem, we of the frankly, so in. shows we're the a have are

Japan globally. part asked on what's number earlier here initial two you question that going about, you the what's was But and happening and going on asked of in what's

for focal another become that of if the that's actively towards ago kind with you COVID-XX something working study not SARS cohort, planning Helios. alongside running is a partnership ONE-BRIDGE on induced mini few at this they're they're a completing. will, long too announced a patients obviously, looking our They that So point

factors that think the it's they're and of practices mitigating is they gone I of of do have because in have Japan that although that some been the natural Japan, And spread culture over on. not of things recognize they working and that's there virus problem with in the other in And world. as the big of the parts it the as appreciate a some mitigating or maybe as the experts that clinical

position. there that providing recognition to can think already for of to that do able interested continue they and a appropriate strengthen well think that's for it's treatment things because more can impact generate there's out are encouraging today try for were Frankly, our like an side I I steps us, the nonetheless, I I everywhere. ill that have general the and announced to critically are I things an looking they've it that in regulators particular. bodes a have and problem really impact. get can a just think we that remdesivir And And are in we've because think all that and that expedited the know that, we regulator's certainly are shown think they approval emergency they're option where have of on taking data so because I companies impact. – as an These really But

XXX% what in Japan except media things the So are worse reports. right, you're that U.S. than much

the there You media. and know Japanese we that I'm very watch in dialed

So opportunity, it's huge that the sure in and on the very opportunity Japanese to treat patients I'm interested. Japan, ventilators are who are a

hopes that the I year surprise. so been said both important one decimated. timelines have talking a know think Healios about, be clinical could And that things had been you and for not this that of that So, TREASURE was other was ONE-BRIDGE. I And

it's here MASTERS, reevaluate think And to than hope I reasonable you'll next still there's data year. say, but more for

on to the becomes stock and we we me that get that before the stroke attractive I potentially more to by see because transformative. and way, on think So do the outcome COVID-XX makes

It's coupled much. to to evolve, Really long so… right? road us that, continuing with you excited. with all Thank and and the watch forward So the look company of very cash been I'm team, for management so a

yes. Yes,

it? there I'm so glad you're you're that and driving

Jason. appreciate Yes, well thank you, support. really the We

Thank you.

Messer question of comes now Chad Your line ahead, with from line is the your next Needham. go open. Please

of about out sort let thinking you sort thankfully? government, on about matches out frontline and normal add and since what the you're the the be could bit drug been, you're medical unprecedented unprecedented unprecedented of my things sort to progress. of just with if a Wondering I talk there pace times. community, with thanks may congratulations and Great, that's of maybe, guess the the the evening, me good regulators window, little done things a there? of I way getting the lot happening of COVID of ecosystem there's mean out the development about thrown yes its seeing been has and

I points, or - to protocol, And much well, times forth, perspective, and covering so for we feedback specific working and need anybody that mean, understands questions to were we I responsive Yes very as particular together has the They regulatory asking a as going in with several speed finalize FDA from the from were can either getting a responsive. incredibly we engaged the on think been I speak. as and back answering questions day remarkably were say sometimes them. the FDA,

more So one of and just to take team. expedite want the to redeployed things. thank They've a FDA try I help to lot effort internally opportunity and the

way it resources internal a are little come to at by costs of their Now, on FDA other lot as I the fronts. as something focus did the operational an and that and know some that hospitals on redeployed people personnel a frustrated was just occurring because institutions, of other it bit

got heading direction. of other been okay, But are of lot the we're a of think sensing sick, mitigation that patients or the patients a seriously And least lot think really challenging. definitely But of gotten at very positive in I the now have people like, I that impact. had is obviously now lot that I it's strategies a in hospital, feel patients There back who some critically have ill. think a

redeploy a where or hospitals personally positive. where they they I people need are Some on of the to them were kind And real to other fronts. as be back beginning of to see that

think of all anybody were I mean, right with absolutely all are critically to you're able work things so done important. to about about get at about move ago, that and little adjustments And the where make that months is day. the ecosystems we've so a the just quickly done things together, living and thinking broader talking now much fact stuff terms every hardly get willingness I testament broader the that. a think in to landscape, and single had that to we been we've we're three over you if So was

I family have into for of loved degree I activities, Now, strong out some things that don't and really they've do are trial of they that in people or fair There don't know, frankly, of a there for sense, putting any been in it clinical will amount or muscle think is as driven there really have noise a things. some a out to lot make resources sheer are members there. people by is say basis the those a putting some of that the experiencing desperation become or lot things. into sick ones have had That really

rational see that top. clarity going and are out that have and the to further happen things the But evidence the start is I we're things expected from going going what's to things base, the rise are strongest the that emerging the really most next to even several over the that, that some to well months Those beyond to are founded.

first hearing at promising. that of or the on of that about people things kind few weeks just to a ago Some things that might pointing based were sound anecdotal we evidence were

the at that evidence what the is argument. day The end wins of

real for that's where up. the things end that might we where and emphasize clinicians make those they Sometimes they that ahead. we come think going don't. sometimes see and to to confident and but is, out I not real actually don't waste not things They're with are potential instantaneously, that happen the to the going stand promise But sense. time going that's up, point is It's I'm things

got but of are that here going mean, that on conditions find things I part and encouraging you optimal, absolutely, I that. there Yes, definitely the very guys are amazing some aren't us and there

[indiscernible]. appreciate I So

I appreciate Chad. Excellent, really thanks, support. the

now closing And remarks. Bokkelen to for like Van the Thank I'd - you. That our I'd call to Dr. session. Q&A concludes turn over

updates as call achieving providing making to to Thanks, additional today forward forward like our Well, and we everyone thank move goals we time advancing as listen continued from taking look and our always, into for to We the fully support. here. Kasie. for I'd announcements committed remain and the to programs your and

Thank and participating. gentlemen, this today's concludes you, call. you Thank ladies conference for

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