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

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.

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

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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

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

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

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

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?

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?

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,

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

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

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

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

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

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

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

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.

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

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

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,

from comes The next with Hoang question SMBC. David

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

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,

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

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

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

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

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

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

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

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

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

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

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

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

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

disconnect now may your You lines.