ATHX - Earnings call transcript Q4 2021

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Operator

Good evening. Thank you for attending today's Athersys Year-End 2021 Results Conference Call. My name is Selena, and I will be your moderator. [Operator Instructions] I would now like to pass the conference over to our host, Karen Hunady, with Athersys. Please go ahead.

Karen Hunady

good and Selena, you, afternoon, everyone. Thank Hunady, for Athersys. Karen Director of Relations Investor and Communications Corporate I'm Thank joining you for today's call.

also provision Any materially for the Securities as to developments important the a is make prospects in we webcast Chief close may our subsequent of If copy XX-K you call's We pleased I'm Chief our market, plans to release. also and the the harbor future started statements Litigation audio constitute Camardo, Operating President may Officer; Act athersys.com. February Financial B.J. that other forward-looking in our Officer. discussed XX. XXXX. today's cause safe The Chief that public under result Macleod, press Ivor about forward-looking Forms and conclusion of a the with the the it of as our Actual available the A press introduce website here anticipate be do statements remarks release from issued expectations, results and of I'm not differ at Private Reform of replay purposes is available including on section. those have and various Executive who our SEC the the will factors, information X website on Lehmann, and Athersys events Dan after for access of at change. filings. Events by our may outlook those hours under indicated on Officer XX-Q,

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

topics XXXX. you over be please was Camardo. to March releases and CEO held turn recorded the Athersys, it now, this the may you With announcements most discussed, the replay, like XX, Dan of recent of we to so For listening then, and made to I'll those have the may introduce I'd our to Dan. press to related on filings. pleasure, benefit who SEC all new Since call reference

Daniel Camardo

minute eager Karen. to in-market global member transformed that $X of products approaching executive an company no experience as have market excited approved market, in on therapies potential with cap has a difficult of market and of are disease and having a small patients $XX I few effectively and prepared of global the Athersys while well that be ahead. privilege helping and therapeutic businesses those company a such than innovative medical Thanks, both believe needs. we Vice opportunities pharmaceutical in highlights of part biotech with February dual XX, some was joining a I'm growing years, in to or unmet head a pivotal the brings enjoy to or leader leader various President a I've the significant be treat on background successful in creating aware biotechnology a have Athersys at and the the medicine my pharmaceutical I Most diseases and areas time regenerative come with to was the a to years leading cell after value. challenges treat I of billion. capitalizing industry Athersys effective challenges I'm faced to meet Please XXXX. allow I'm and Committee cap Executive delivered teams, and more with with on of share where me Therapeutics, building a of also especially to over team into that it numerous XXXX therapy and specialty Horizon before Executive products, the billion recently, I launching options. XX the satisfaction XX shareholder

capabilities assets commercial created, collaboration and commercial exceptional repositioning culture experience core acquiring developed highly undervalued we and XXXX. XX the entry build tenure, grow by them proud disease values by that other driven America I profitable to Astellas Pharma significant rare transparency, years with us that products My business diverse of X.X-year the to we and I'm accountability. portfolio our was the where Yamanouchi enabled Pharma, my starting and of U.S. high-performing market in results-driven of spent at a in During marketplace. of also the

number in the During a with my and $X for built for the When than Medivation. XXXX, sales. of and the in following leadership a deals, more portfolio time And I launch had chance prostate XTANDI areas and a I GlaxoSmithKline of Astellas co-promotion left reported company billion merger with of we care. U.S. a successful castration-resistant licensing bladder specialty with I in company and most oncology, net commercial build-out with in the hospital cancer immunology in products a to played broad role urology, of the several Astellas, Vesicare overactive had of participate Fujisawa products. innovative notably,

to and up financial with a million. of a join Now many capitalization less inflammation executives of be and Athersys, top was of to with highly along rare disease businesses and with $XXX me valuation would why give a $XX people the I the my where for at responsibility scaling role asked come I one profitable market Horizon, a that have successful rewards business than billion leaving company Horizon's

diseases patients passion First, such But bring biology for to and to I of for the to serious quickly to significant and its with researched employees for let as growing that market company basis but and scientific MultiStem life-threatening treat devastating diseases action and and and Board And saw distress are stroke, me our commitment be suffering by costs. and I although out I cell has intrigued. a therapy nor Athersys of demonstrated been a was became These of reached in not area a health new families difficult acute when cell become to interest has In MultiStem the from the help result deep only Athersys the more expertise than company trauma. respiratory recently me, can syndrome Horizon. the say leave industry, looking particular, scientific effects individuals mechanism stem XX years. company's in the to more in care and studying job not

of this I was have job While would due not satisfied all interesting, was into own taken company. the my with the I unless diligence

CEO with agreed share me I of that let Athersys. position diligence of I before So you accept the due some to as the completed

with Directors met ask I Board the every the facing company. questions the about of and First, challenges pointed opportunities and member of

capabilities as the with it member well to company's management met senior I the needs work as team future the every of Second, internal commercialization. continues to towards understand as

in the at treat better patients consultants about gene diseases of the February Since several diligence therapy space scientific who substantial Third, recognition for in the acute from leader with joining challenges to job I unique my I MASTERS-X to research manufacturing lastly, place. properties, generate Athersys medicine, spoke Athersys not team about this conviction MultiStem's have become And the Fourth, the new company I and we My the shareholder stroke full syndrome. I from spoke business regenerative challenges of action. distress the in the understanding in these opportunity only and internal evolving of on and got leader a several a the the suffering learning that studied cell and mechanism confirmed due I area preclinical Horizon my become accepted and better in all the reviewed and been respiratory meeting has clinical prospects had understand And regulatory with industry. various very initial and about with more physicians that treat difficult-to-treat especially excited and me the the for have company conviction but facing papers also resigned a with opportunity, studies, who basis and detail. value. stronger. interest unique XX even MultiStem's faced

like MultiStem. received is related time, cleared believe There may Japan and of cell different stem cell which been the the stem is the us other types multipotent MSC, disorders. an Specifically, the as our of cells, than than or other hold protection our which diseases and the importantly, well And to mesenchymal MultiStem with over Most we have patents tolerability. safety across than all body therapy. relative from biologics, adult to And XX areas. different XXX results providing a demonstrated MAPC conventional enhance more in platform trials candidate attractive immune branded patients those inflammatory a more consistently very therapy, more technologies, on good with product and and trials we in as have completed, Europe, MAPC, XXX from us U.S., analysis safety product neurological already have type provides distinctly drugs publications IP scientific with more cell. clinical growth the potential From highly significant progenitor or

to Over scale and made a you as year, and significant manufacture MultiStem a have which, of ability cell investment be challenge efficient in know, the with many predictable manner, last we can stem other therapies. and in progress our

and new development our In with who at the includes with which in capabilities for will and both so technical partner, and experience both commercialization addition, proven that members year the manufacturing, the over plans executive further teams impressed I've process started Japanese been several company, Healios. have past help support or Athersys

exceed both And completely employees, will commercial like of we leader expectations as enrollment. we all complete partners. style to the or I they meet work believe expectations, and with of mind, Athersys, to as timing trust know MASTERS-X what those it on can set be it's in the and I'd ambitious My be responsibility is. to that it and transparent to expectations. And be to diligently achievable. say like When the new my is As to constituents, all I earn key will address shareholders I

the undertaken addressing initiations the trial to pandemic this to by local and patient due has soon issues enrollment things. product currently accelerate the to well of intended These abroad increased finish as its patient in possible Over new site and as enrollment or site U.S. end of and as XXXX enable openings company the intended as including actions supply experienced among other MASTERS-X of that challenges constraints. and initiatives in screening clinical to sites operational supply are and last study site COVID-XX the the We've disruptions enrollment at couple opening, thereafter. are years,

execution a strategy, mutually corporate partners lot of partnerships critical for like accordance on overall would company. is partnerships. area the particularly Healios say It's align I'm developing agreement with a important strategy building experience has comprehensive that and these with that and It the corporate among dramatically far so structure win-win framework of today record between and the I we have healthy, interests February execute is pleased August and biotech cooperation Athersys corporate each mixed Another I fix successful the company. formula to beneficial agreement XXXX, XXXX of to the fair see a the for following relationship a improved. a This that. partnerships, the and is address corporate to to had partnering. Athersys of in in element intend has to in in

that partners very companies can way with both on relationship continue matters, that ensure and are beneficial mutually Healios. a commercialization In report Japan. this deepen to partnership mutually to I and we working on a supportive for as in our together preparations confident fact, can manufacturing build progress true closely in I'm regulatory

in a potential several important the for will success milestones to be of on on And ARDS, and for every the to results the TREASURE every important potential status with manufacturing. and of assist Athersys step including commercial initiatives. some trial a regulatory collaboration, of way approaching of and support our finally, for stroke like these unblinding one release make launch are preparations comments closely the working Healios We Japan. filing I'd with Healios

inventory yield over The sufficient necessary to I'd factory issues with for Healios using to in have to With large-scale launch of potential trials the by the growth been Europe volumes as the clinical and a the We The company And substantially as to to in is the process, trial potential regulatory initial build process various of Japan our quarter. stroke now product support have initial update greater start the improvements to on has this intend years. clinical transition can in successful. II for results Lehmann, manufacturing in the approval an company our FDA of platform point Phase first-generation and to launch second-generation the Phase delays States, clinical Japan. and product and all larger-scale working that larger a and to building the end production world. process, the for based potential our it production and up commercial will we our to III on ARDS bioreactor this will has support to of timing the second been future upcoming product intention Phase II/III well turn provide ongoing bioreactor as experienced runs we this which process bioreactor as for over be the process test out cell B.J.? requirements that program and commercial And And with active United in who will B.J. over in like trauma. well rest clinical our milestones. a program needs believe

William Lehmann

you, milestones of therapeutic program, demonstrating the important stroke treatment. of Thank us our we Dan. In ahead have benefit MultiStem

other we conducted TREASURE study in over analysis this that this from term, In conducted data moderate and by the the month, severe the is TREASURE partner First, treatment and Healios our completed patients strokes by announcement Europe the The the study, next Japan Japan. be several being meaning is last of efficacy MASTERS-X the looking can are to from ultimately follow-up over upcoming population. evaluating weeks. being detect to study The intravenous patient clean-up powered regions. XXX MultiStem U.S., results followed the study in forward completion to near larger our is of in expected well with data of and

the their meaning results have strong communicated study. prior study would the demonstrating for MASTERS-X the results and about impact design, have results we study in optimistic our for the and therapeutic As the similar previously, on of Based potential a MASTERS-X TREASURE are the patients. TREASURE potential studies from designs, indicator be we stroke that MASTERS-X

make Additionally, necessary to and the data any our confirm would enable strategy design us adjustments. MASTERS-X and

closely progress quality confirmation Healios' work package providing commercial to process Naturally, commercialization. us, royalty regarding for to would sufficiency continue and the Healios milestones manufacturing certain application capacity and to further will and support payments. of ultimately, in We establish with the initial regulatory application and and benefit the Japan

We make to challenges in continue other pandemic as as screening faced prior our clinical among initiations enrollment Dan site the to enrolling progress and things. due periods, COVID-XX we've supply to study. interruptions, MASTERS-X well mentioned, as patient In

including intended and has to site site-specific addressing supply we increased new U.S. As the decline enrollment COVID-XX sites, case abroad numbers accelerate open initiatives and openings stabilized, and have undertaken patient by in plans These the or of and to mentioned, to 'XX, soon inventory possible operations the as intended enrollment of end enable thereafter. issues. as as Dan us management are finish MASTERS-X study at

first the activity bringing including success initiations recent resurgence enrollments However, on the further United patient site timely clinical interest Europe, to of us completion initiated the sites. States. drives our depends study and the and And and in than instance, success results and amongst of of had we've focus a In results would have investigators the accruals the groups. possible new positive more study research as months, XX sites, on on favorable TREASURE and have also of We Australia, we XX would Taiwan in initiatives, impact outside for effect site that and these COVID-XX. TREASURE expect, patient

We the and We of important vigorous expect contributions efficient will the study. these the to to additional continue in believe initiation enrollment new U.S. of sites MASTERS-X sites the of be outside.

On development the have front, utilized with our our plans. RMAT about frequent we discussions have FDA the to designation regulatory

pediatric agreement following and This plans reached for regulators development complete to because address such an report approval. are defer marketing will approval. have that European is our it we prior pediatric to we to not that have with development stroke. applying development development we We pleased can the means important U.S. But to for

our other programs. Turning to

to our COVID-induced this not MACOVIA ARDS study population, recent As we general just which in longer-term communications, a more patient we in have with stated our development consistent ARDS, area. amended is include have plan

and activity. complete operations for study other of to the pandemic the II plan MACOVIA Our COVID of part site depending, work end incidents is by things, level the Phase study on XXXX, to among

ARDS pandemic, plan proceeding of COVID stock Given changes we III patients in program. the care to light before take with clinical standard MACOVIA Phase the the of for in of portion

we example, approval product quality bioreactor high us cell this Even successful to scale recent for improvements work function, subsequent remains from data the study, able MUST-ARDS Healios and have significant of system larger the from and by mortality from life. days FDA, of from are In and ventilator suffering ARDS, with top clinical on respect format. trends to quality recent number enable care Due data health the data reduce study life product with line been its from our importantly, ventilator-free a some reported our mortality for This clinical August the care therapy next-generation use of a favorable pulmonary and the need. the lay high XXXX, in could to ARDS savings demonstrating improve for the bioreactor in be Importantly, study generate in manufactured with a on generate patients. an Japan cost is could of area bioreactor-based ONE-BRIDGE The and ICU, consistent treatment reducing ONE-BRIDGE will though expected to COVID-induced clinical for and impact groundwork ARDS of the unmet data study. to days, for valuable the pneumonia-induced standard in of with made, our with the condition. those the

the have standard same shortly we MUST-ARDS the comparable the readout, trends the top excluding and Following and were ARDS the XX ventilator-free studies, in studies amount pool survival, thorough dose populations remaining receiving and care. COVID the studies. from ARDS quality studies, cohort enrolled ARDS MultiStem life of in were receiving patient subjects analysis reduction the treatment VFD, have receiving ONE-BRIDGE ONE-BRIDGE inflammatory or observed of the XX Between study, diagnosis. of line improved the a key strong conducted an or biomarkers. Healios days, placebo On data ONE-BRIDGE XX The and of MultiStem following basis, in

treated median the treatment MultiStem have basis, application its of favorable had, XX.X diagnosis evidence on the confidence nontreated subjects first strong of to on approval. subjects the Healios a than period. more treatment the example, For on on marketing metrics. from This positive life X.XX. a Further, p-value was during for days with impact more in for also average, with XX data mortality ventilator-free XX-day regulatory us there continues days and ventilator-free X.X following days and that in gives further quality potential to ARDS authorities potential MultiStem manufacturing for substantial prepare combined consultations a patients. impact of And

are which, closely forward Japan, announced and with XXXX look working to potential them to regulatory March We the prepare Healios in approval if allow preapplication consultation Healios. applications by marketing for to the successful, approval. could late in We commercialization for in achieve

injury. traumatic grand the Medical supported funding, is United X Memorial in As for BARDA, at noted trauma the and and wide and Texas therapy also treatment previous plan Level UT in a federal exploring program we is evaluating a opportunities including trial the II a Center the there Texas, treatment support from range for fit our with result therapy the busiest trauma, injuries for the the the centers in States of of injuries for following continue call, conducted being severe of clinical government. the we study Hermann Phase by early traumatic traumatic cell MultiStem is of Houston, a This to one such conducting strategy. by development are governmental evaluating we first-ever of cell as where complications Health In that subsequent

ischemic, or victims, response great suffering on and the therapy others this MACOVIA and critical as using in other in bioreactor events the survival accident the immune casualties improve improving study by with is of generated path. quality from have case benefit inflammatory potential traumatic As our are battlefield the the we with the care FDA, The recent believe infectious of We study, should therapeutic life. elements such modulation traumatic response the the of and severe trial. MATRICS to recovery, the reshaping by programs relevant injury builds system approval products to recovery manufactured the MultiStem

support and an collaboration on beneficial. success incentives optimal commercial create in take regulatory manufacturing amended Dan's Finally, and to and were better with In collaboration I to led develop for to and arrangements Healios full Japan. strong joint have on for manufacturing, and our efforts Mechanisms Athersys and and for In that in to to update intended Healios, I'm to development these improved on manufacturing would align regulatory we building Healios time a confirm XXXX, over Japan. Japan. approved the drive efforts comments. to much greater commercialization programs pleased general, changes ultimately, like activities provide framework supply with MultiStem opportunities in and supply responsibilities in and both our investments parties for

process, which the data that, study a Healios and are financial capacity provide the in continued platform. longer-term commercial hand establishing We to of over regulatory look forward initial to to applications will of working TREASURE the the the market. with With Healios for regulatory Healios progress in development We assist the processes milestones for development closely for in Ivor Ivor? manufacturing plan and now by important Japanese update. to to MultiStem represent and it in support I the commercialization supply upcoming and

Ivor Macleod

Athersys. Officer I'm of everybody. joining thank you afternoon, call. Good B.J. like you, Ivor of Macleod, all for today's Financial Chief I'd Thank to

million months X December months period the and an of General XXXX, we provide December in $XX,XXX supporting partner in fourth X the increase to revenue services of give financial the were collaboration expenses same the quarter a for to and ended Healios, XXXX. it $X.X $XXX,XXX development results follow XX, the Revenues First, with ended I'll The and compared for to compared for Japan. personnel minor our to in months compensation to fees for the million XXXX fourth $XXX,XXX due was from lower for in the and period of The $X.X expenses ended professional decrease comparable costs will primarily net XXXX. of the $XXX,XXX. now fourth XX, results December compared million turn XXXX, quarter the loss the the service, costs $XX.X of XXXX service of full lower for $XXX,XXX, year. $X.X for The in our quarter X were ongoing Research of XXXX the administrative in offset expenses decreased by the outside $XX.X the XXXX. to quarter was $XX.X is million to XX, fourth loss that the overview and in legal then million to year. net I the million a comparable of of for related in XXXX. stock increased full period

$X.X Our Healios. $X.XX in revenues were to million related compared collaboration in ongoing primarily million XXXX to XXXX our with

Our period to The collaboration expenses these costs XXXX. of development by trial ongoing of from an process clinical related million, Research the to increase is arrangement is in in in million. overall $X.X compared expenses partially our an primarily Healios offset large-scale increase and services related and period to our the progress a to in increase development revenues costs our fluctuate in on currently million other and cost $XX in bioreactor were . of and with to in based manufacturing trials. decrease expenditures XXXX personnel associated increase $X.X delivery clinical $X.X million costs under manufacturing in $XX.X primarily of The million, goods and related

of other professional trials time, includes initiatives. executive severance manufacturing our on onetime point important and The $XXX,XXX. in with development related it's of litigation underway, to services, framework personnel fees million well XXXX, past and as aggregate, is expenses to these Our outside million approximately compensation and Healios in primarily In vary we the consummation of $X.X in variance $X XXXX. overall $X.X based associated clinical the costs run campaigns were experienced excess to million administrative well compared related increased significant activities onetime out to associated of $X.X R&D $XX.X which of million; XXXX will $XX.X to stock-based legal our were we expenses of continue and as In continued expenses as as million and with in number agreement. the comprehensive subsequent million, over professional General XXXX. expenses process services

difference ended In XXXX million $XX activities XX, The cash Our net at and net XX XXXX, $XX.X the months million variances. million million million operating December XX loss in $X.X in XX, net equivalents was had aforementioned we million $XX.X compared $XX XXXX. compared was in cash XX, in XX, $XX months used XXXX, $XX.X December a of December million cash the loss to reflects At to the XXXX. compared December XXXX. to in ended

Our cash and varied fund million $XX per Healios' burn adequate have We the top between being publication XXXX million. quarter million do with $XX quarter, in line and fourth the priorities cash in our stroke of over we feel the to just burn $XX near-term through data. beyond

back capital. positive to continue line over to equity meeting Q&A. Capital, I'll line for Dan While further to the With raising we Aspire could with turn stroke our Dan? with have access top that, data provide us several for options

Daniel Camardo

to we've press. that surrounding to you, from position and And now like analysts. in call before the Thank ahead had were current questions we time questions Ivor. our We'd up open sent this questions address stock several of our financial take

address to items. to these So Ivor I'm ask going

Ivor Macleod

Dan. you, stock current the address questions about price. first Thank our I'll

around is in our geopolitical of and standards, price for The We only capital is in period year, occurring approximately period XBI in follow, low the poor. Healios million not S&P number dried approximately on XBI in XX off and is Russia. a segment has X.X%. of represents economic to compared today policy this company cases sector, stock XXX year. XX%. market for increase have potential of late-stage the at The believe the in severely the rate tomorrow. been to been stock China, Against also down The biotech year. various in from backdrop, greatly is of is the XX% year. and their NASDAQ sentiment global Follow-on S&P meeting heavily lockdowns this biotech zero to but guaranteed, And biotech That but is December the to year. weigh particularly low what Macroeconomic outlook up overall global continue on leading Fed inflation, to especially tolerance this tends imposed have to uncertainty said, which the our a particularly Total readout they're our biotech the is digits by that $XXX similarly important crisis Index will to Ukraine the comparable markets the being in development There's X.XX% our significant almost which undervalued, be supply on we in single-digit data in more sanctions extremely compared the outcome in a corresponding against further Japan. The the cusp permanence partner the believe the Index, continue IPOs factors XX% the COVID Market overall Index. this sentiment. the the in interruptions are nature underestimated year single and somewhat IPO with last chain. while last the

of While our the priorities, do the the our to data here than stock boost at Japanese we particularly mentioned for Athersys, we stroke call, which price, our release we to managing partner, the from expect a our overall catalysts, valuation. with TREASURE continue earlier near-term in rather provide

through of line adequate we us catalysts, getting I earlier side as top have of other situation, to cash Regarding including our in our get publication cash the near-term feel said the call, we data. the the TREASURE to

than raise be for what believe us current positive be we better what will data, anticipate much on to terms. capital multiple we additional Following would opportunities

Aspire. to to also We purchase with continue equity agreement our have access

that, to hesitant While back level, current are the lowered it over flexibility it I'll Dan. $X.XX, sell required. price have which we at be to the the should gives us floor to price give With we

Daniel Camardo

the MACOVIA Ivor. several ARDS, on this our plans our trial progress for may and our Cohort questions Cohort of affect X relating treatment how received specifically about you, Thank also to We've X. for

B.J., some insight you mind So for wouldn't if providing more us?

William Lehmann

Sure, Dan. I'm happy to.

mentioned potential based I So are help to patients on about we few recent minutes a data, our positive very research for ARDS. therapy with clinical MultiStem ago, and the

this manufacturer we the of to FDA into to we design confirm our product to X in now our study, And providing portion bioreactor integrating recent approval, addition Cohort In planned X study. with our the the of for have product be used. are information Cohort

more best cohort In as have With addition, complete the confirm for the that and that to hope, hand, end potentially forward next we enrollment moving the our year. design we Cohort will we the success be of of data X I design before, mentioned ensure in by clinical year. before adding X sites, would we this some

So Dan?

Daniel Camardo

Great. Thank you, B.J.

that relates I'm this comes why up we'll based take by in year? be of topic this the number we think Another open MASTERS-X. MASTERS-X, of enrolled one. to on And happy sites the And end to do

in sites COVID-XX we and sites initiating States, shortly. have over the Europe last mentioned, XX new months and B.J. just As as the we initiate several now United sites XX Asia hurdles to have more over open, plan diminished

and stroke are are high-profile research capabilities. stroke these institutions advanced centers research the clinical and care Now technologies, leading all often sites with most

at actions open completed more Importantly, manufacturing to improve while clinical we nearly with our and enrollment The put be to in in which are for trial, supply us the current sites. was around several as will aggressive the this place question. expectations clinical enable our next we've So this set received What it to you study? taking what B.J., our we readout. are this MASTERS-X data upcoming mean if of and won't treasure relates mind does questions operations,

William Lehmann

that. ago, February, particular, a in the remain we've few I minutes MultiStem from to in as in plus just No, on confident observations respect our ischemic with about before discussed all presentation for past, research earlier based the MASTERS-X stroke, trial we the potential Sure. talked our our we in and in conducted very

TREASURE X similarly would the favorable Dan? high that to have we from believe are designed the MASTERS-X, and We well through both results will success. studies in study are that of and for MASTERS-X learnings meaning confidence MASTERS the on success results MASTERS-X. TREASURE from powered Importantly, the read and based

Daniel Camardo

Thanks, another questions related B.J. There's process. cover, like don't topic to mind, that bioreactor you our to I'd manufacturing several general We received B.J. if

on provide can you front? this on an update So progress

William Lehmann

happy do that. I'm to

commercial potential saying, markets manufacturing First, good following approvals by we process us as make our serve as partners very in and we're continue the progress to such capacity . our Healios developing bioreactor to or

recently manufactured our platform use importantly, product As received for earlier, and using clinical have I approval mentioned we bioreactor to trials.

data transferring will process, work capacity. we to to initial work. our necessary bioreactor process, the larger-scale, X regulatory are establish the doing successful including manufacturing clinical demonstrate our even interactions Gen we of next-generation, Building to comparability determine with possibly made bioreactor to continue with larger-scale for product regulators the technology GMP on Additionally, the bridging

information be there'll move more So forward. on as we that

Daniel Camardo

countries with received results. and lastly, These focused the you, Previously, States also engaged influenced in discussions And well-established Thank comment we've be B.J. data outside partnership be will and licensing company by and the companies pharmaceutical on opportunities, licensing to United on questions upcoming around several in Europe. primarily discussions our discussions and happy this. continue I'll

our seek our development for across this As everyone, that happy be this of time, will any we strategy to for the you we and ahead At questions from of overall further take States. including analysts. other submitted region, questions MultiStem, would possible potential stroke indications reengage those United Thanks, partners to we for call. business evaluate

Operator

first [Operator comes with Harrison BofA question Instructions] Greg from Global The Research.

Greg Harrison

sounds XQ the it to it So current with cash rates. like at respect in runway, would end

the And So to near-term is with if payment? financing strategy lead the a first, TREASURE accurate? so, partnership upfront what if is doesn't data an that

Daniel Camardo

B.J. -- that, Take Ivor? sorry,

Ivor Macleod

Greg. Thanks, Yes. Yes.

to So the a dial between to with we quarter. course, $XX correct, of have cash at rate enough and do it we second -- have or it of the $XX of a dial with through million, end least you're down. million up, ability burn get But run the

yet. successful could means financing, access provide line, If which have other mentioned, had to financing. partnership, I I give have data the As details do a lead just want of not we our really explored to equity does the to which don't we

say, we're other have on be But the positive. the far are there the to our the not suffice discussions to that anticipate And do intention we with have debt possibilities proceed on We our not accessed pulled But to exploring. readout is we it. markets. trigger And so partnership.

Greg Harrison

they even of be expect the when to potential time a under when as follow-up. Or discussion if deal period? now could In pending that of data? that it. are that partners, short having just a Just you’re it discussions see something have announced? within want could Got to positive, sense a that your struck is quick be get could we feasible to with data a And

Ivor Macleod

Yes. great It’s another Greg. question,

the teams, they very, quickly firm expect side, I with diligence What move. to on it’s but the the like slower it very to to of possible. quickly, on be put pharma, As would move the we Athersys the big know, we we larger as are – can We say you as we’re experience due and large though difficult consummate even is nimble. the these But certain in it. the months, pharmas, down date a it past with types things, our

Daniel Camardo

So opportunities. I’ll looking add, at the only be thing Greg, we actively will is

data So maybe explore but improbable to be TREASURE comes the will up before those we efforts ramping opportunities. out,

Operator

from comes The next with Hoang question SMBC. David

David Hoang

company, the all glad aboard. to you welcome Dan, to have and we're

So a had just I couple.

the looking what as the partnership? from are your terms in you to just kind exactly a outlined sounds think considering do little helm I one, of little What bit the success us. for geographies could you are like with more potential think, But color in you broadly. a about how And point maybe for view? First give constitute you you, it now, of It would the partnership, you of partner? ideal bit at

Daniel Camardo

answer to happy Yes, it, David. Sure.

is that first, success. been a I on partnership sure Healios making our has think attention our

And continue partnership be the of stroke for ways last ARDS. over that successful, to And at and both with we'll year. so lot look into been a work has to going us

we're going to may be and really all I the areas look take think at back that appropriate. outside that, a MultiStem of step

have we that it what opportunity process other looking MultiStem to a partners. a rather at know we explores just than potentially in indications, various undertake And by going we're platform uses regions, MultiStem. with I other do is of approaching So think

that it's putting but to quickly. that going are we've something not it's so be place And we in started right something away,

David Hoang

very just terms from in may products we example, filing or in That's wanted expect of milestone for of And you the completed in Dan, first receive I helpful. that when is expect any to regulatory do this on to year, payments commercialization Japan ask Japan? -- Great. Healios any ARDS

Daniel Camardo

to that? B.J., do you want take

William Lehmann

for Yes. question. thanks Yes. David, the

do development. payments We based expect haven't year Healios expectations the on from but of our disclosed milestone specifics payments, milestone and we for activities this

of that, than say really more much we how can't we but built that's kind about into the So year. think

Operator

Gil from Needham comes question Co. next with Blum The &

Gil Blum

great directed it's you have you. a to board. first question towards Dan, Maybe on

So space, a seems feel considering a mean commercialization experiences kind Horizon, translates this rare stroke with is MultiStem. the in I bit more but well your indication. ARDS in in we it disease relevant of large

experience? your on color some give can you If

Daniel Camardo

specialty experience spans kind markets well rare as of Sure. as Sure. My disease.

taking we'd patient therapeutic approach today. at advantage. at a MultiStem. thing most capabilities, in available I on what too, is one the will I and that it And population the the for The think advancements really is kind market That a is think, be essentially just depends which target area look I gives understanding there's looking us, the market, significant the we've appropriate. been highlighted significant our manufacturing of say, on call

market, Athersys be this available particular look in disease, that in it a we potential think is and my a with in the engage each opportunity going case viewed I experience so that we in partner and have even space. option as make constituents rare stroke forward as And trauma ARDS sure markets treatment in to with an or at or MultiStem

disease, activities to rare that of MultiStem. in we over the so for looking what at at look And would well translates we're think, some I

Gil Blum

for the that All quite in right. Usually, versus is in question the potential Maybe different another Is here. for approvals regulatory than U.S.? approval divergence there Japan a bar U.S. Japan in

envision So of expect might approval? will U.S. for would I in bar which MultiStem you situation definitely can Japan sort you the in see but stroke reach not a improved in same

Daniel Camardo

want that? you to take do B.J.,

William Lehmann

see regulation have create some take and completed of efficacy for as to large-scale from benefit products And able might partner Healios. that the for as some opportunity That's sure. an those favorable regulations. and I'm advantage approval they know, have U.S. to respect of matter, jurisdictions an the that our opportunities with There some studies. not U.S. if It's they're jurisdictions We laws that Japan and that the Yes, of Japan, that between generally. you Japan products. and and established in is true, divergence between regenerative insightful pivotal Yes. other yet We divergence in more that for possibility medicine question. other sure

in have fact, way, in our by some and things quite we're be there and developed But them relevance as We've the the that give across the these a Morsy, approaching In you're going trying we're TREASURE geographies to study in way, divergence. a an common of geographies, information led though opportunity the time full is that Regulatory, we're Head in common work the packages approval. that a studies way that different that making geographies in to in running we sure would that Manal right, a spent hope well. could other the confident for larger is of out lot read

everything the on, for well. we're geographies, to But us. this optimize outcome doing could Japan across I and at we'll think to we really benefit that, advantage there our with take day the end manage the of of as the some But So be can you're partner market. right divergence would

Gil Blum

on your progress. Thank Okay. providing you for Excellent. on that. clarity congrats And some

Operator

over for it remarks. our concludes Q&A, This will closing turn and I now Dan to

Daniel Camardo

very very exciting thank and – in looking are to year forward We much. much, XXXX company, Thank Thank to all we earnings the and XXXX. you very ahead call. you of support for value your you listening our a

Operator

Conference That for concludes Athersys Results Call. Year-end Thank your participation. you XXXX the

disconnect now may your You lines.

Athersys, Inc / New (ATHXQ) 16 Mar 222021 Q4 Earnings call transcript