Athersys, Inc / New (ATHXQ) 16 Nov 212021 Q3 Earnings call transcript

Good day and thank you for standing by. Welcome to the Athersys Third Quarter 2021 Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator instructions] Please be advised that today's conference is being recorded. now today. hand would to conference I speaker your instructions] like the to over [Operator Director Corporate Hunady, Karen of Relations. Communications and Investor Thank you. ahead. go Please

Thank afternoon, good you, Abigail, everyone. and

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

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

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

Since press SEC turn to reference B.J. discussed, the made to on to November please Lehmann. this our topics be then to that, like XXXX. replay, recorded was filings. who so most call held may those of I'd of have the and and over recent announcements we call may benefit B.J. releases With listening the For related XXth the

business activities the and Athersys recent and our and behalf team an overview developments. call On summarize will corporate I Thanks, provide operations in Karen. of today,

In our an emerging XXXX. XXXX reflect positions. on then focus and on provide will Company's update for financial performance will addition, I our the I

We shareholders by our will open to then address several it questions general up submitted Q&A. and

comprehensive updated website Company overview presentation. refer I platform. our our and you to of more a to corporate For and would our like

an ARDS program. provide on update we First, our

to provided for our update the followed As from program, from which is release thorough ONE-BRIDGE treated mortality quarterly after MUST-ARDS a Study or call, appear the the ventilator-free Study. consistent of group summarize, Healios MultiStem days Study. in we the over be To reporting with in our VFD a the standard Healios compared last shortly lower ONE-BRIDGE from and period, with higher therapy. results With XX-day data results

on placebo from the MultiStem pool XX the with in presentation either its which are an quarter of an in to corporate patients programs, for a higher. of pool designated presentation that lower of ONE-BRIDGE treatment Q&A financial on as receiving plans our mortality XXXX Medium to in both data, of the also set ARDS data QX the ARDS compared a Healios data adjusting using studies and cell third a P Lastly, to data this VFD for with JNDA in includes website. of COVID provided those treated of treated MUST-ARDS, days updated severity, ARDS product. VFD corporate patients compared age, was impact. in According and is average it This which was file a available a MultiStem strong suggest with in care. XX regenerative potential orphan results analysis medicine or therapy preliminary standard signal treated XX.X XXXX is test. reported update two-tail Further, statistical and also when conditions, -- to higher and substantially analysis, baseline the are days XX.X group. differences was trend These deck, Based MultiStem group group, our there to our value non-treatment X.XX

announce We on look shortly. to to treating be induced the describing details other are our results forthcoming. has also accepted Further progress been forward by pleased and manuscript will MACOVIA continued with pathogens. study that We the Study, COVID patients for ARDS publication MUST-ARDS

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program. Next, we stroke turn to our

evaluating top-line release clarity disclosure months TREASURE Simply of not has patients. on our about data we its TREASURE to press administration has enrollment Friday, further been noted several delayed, completion the study announced provided timing ago. Japanese Healios MultiStem study, put, from stroke of the was As in

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patients that study ischemic administration impact therapeutic following to shortly the TREASURE optimistic show stroke. from will are We an

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second Note the MASTERS-X MultiStem XX-day in primary measures stroke excellent the that this study, treatment outcome would after as results, days, X-year XX shift of likely quarter the respectively. XXXX. continue Additionally, of patients approach MASTERS-X who including in make and to for and within improve studies hours shown measures, in during both several available the received MRI TREASURE outcome the analysis, XX outcome

outcome proportion Translation, another of XX patients serious For X X back-to-normal achieving patients XXX out example, months, of a at year. were MultiStem from And days. XX% XX just the XX at treated days XX% of at more improvement patients XX by XXX non-treatment by normal excellent degree were this essentially compared increased X year. of achieved back year, where X had to back normal by to to only and stroke were X X

making that and the in We preparations making continuing Distribution spectrum, mRS regulatory MultiStem the with particular. planning outcome to and areas in observed severity MASTERS-X for X across the await JNDA shown positive progress forward manufacturing in move also for for on is TREASURE would improvements enable improvement evidenced, data we're by presentation. treatment the eagerly as study. We're Healios We in which our corporate year, is

and we've calls, and by communications previous the in XX COVID-XX challenges noted have constraints. months, the past we As had over supply

have development we operations focused quarters, on-site to our enable objectives. past the heavily us level over to However, meet

clinical hope recently for the engagement figures. other eligible investing Based of research We complete planned to and of initiated operations, be also have our assumptions of study. level end important local an pool element and investigator enrollment plans sites problem-solving the sites number research and we including personnel site as activity, study. have personnel of the network and U.S. accelerating We've and increased through deployment, communications. the the continue the support to to monthly increase of United we sites, meetings includes the Increasing meaningfully to This will site supplement more the on patients level current outside outside our enrollment clinical and before States in regarding site XXXX. been site and

to A manufacturing other in planning outcomes making with studies a costs, to on on products unanticipated we enrollment improved the both MASTERS-X stroke and moderate-to-moderate chain even the a major and that distribution supply change as proportion activity, supply patients. However, we've multi-year timelines. are treatment site ischemic cell factors the and show marking. well-designed believe in is if for for emphasis remain To product product hospitals. patients. summarize, well-powered chain initiation, our operations regional from and area impact of and of impact past, and supply We impact severe preparing confident TREASURE the significant may Company, treatment in This for with or positive surges therapy's scale security the stroke and is of focus MultiStem reasonable discussed of COVID for and potential at or the product products redundancy, commercialization the enrollment and effort

in scale base our capacity production We working and our make progress continue establishing with fashion to experts bioreactor a align and internally with regulatory with stepwise commercial needs. larger outside build to commercial to manufacturers process, in

Secure the made technologies and have for advance thinking Freezer and our localized or mind. we how And our SIFU with our distribution. Alpha work Prototype We completed progress relationships for recently, the in to substantial in would supply in product long-term practice. Integrated we redundancy continuity solidifying have Indeed, Unit demonstrating SIFU, continue

As focused of set we completion open And have in partner in issues of discussed with stage with been the manufacturing substantial commercialization. development focus Japan distribution area clinical Healios a previously, have platform chain, resolved noted for We the supply on generally advancing and the initial made has and and on development, progress commercialization planning and supply our and chain XXXX the preparations of for speaking, to programs we our as manufacturing above. Japan. development

our in We study. our particular, have short clinical MASTERS-X of development our in fallen objectives, progress

as discussed a taken will trajectory to improve have that several our and execute progress. actions However, we above, strategy

actions. XXXX, look and would As in several themes be important forward objectives in reflected we our

manufacturing we await products Japan, internal the plan commercial We our substantial clinical support data enabling we be of and supporting our a completion which and soon a from effort. our as partner particularly and Also, devoting possible. ramp commercial our and in enrollment plan treasurer our other setting, we development, efforts study, and developing support MASTERS-X of and continue strategy. further as commercialization, to personnel capability reimbursement noted As in up to studies to building is important out to our multiyear the is efforts for to supply providing access market will preparing further intention

it the the partner plan we more to drivers of focused applicability In critical on will activities, that, X we and to efforts will critical for our or care the the the has turn commercialize continue With the over term. I remain on near value possible European develop platform believe for update markets addition, results. securing an broad MultiStem and with indications. Ivor our us Though on best focused potential financial beyond current in to we

results you everybody. Good for the Ivor the And Thank an you, my you Financial B.J. once of of financial overview for call. to of Athersys. again, give joining Macleod, XXXX. thank afternoon, pleasure I'm And third Chief it's Officer today's quarter

our the September XXth, compared to Healios. recognized for XXXX, For million X ended ended the revenues with we in related $XX,XXX X to months XX months XXXX, September $X.X collaboration

Our in services The on decreases These costs based $X.X collaboration arrangement with associated of in million -- for XX.X personnel clinical by and expenses to period partially $XXX,XXX. revenues our with period-to-period increased Research million outside were decrease comparable trial offset goods currently under fluctuate service and delivery the from and compared decreases XXXX. process development of Healios. is development. primarily an manufacturing -- costs of the

Our clinical campaigns manufacturing projects. development clinical manufacturing, and and manufacturing development clinical trials, for process

the primarily $X.X quarter mentioned in XXXX Our of months million, loss period a general ended is XXXX, variances. for compared million million a in and decrease quarter X XXXX. previously the at the The September The and million Net $XX.X consequence administrative the expenses to was loss XX.X XXXX. remained the consistent of difference third Net of of for $X.X third XX, comparable of

During the cash XXth, months million million to in September months in X operating was ended used X net XX, $XX.X XXXX. September $XX.X XXXX, ended compared the activities

XXXX, $XX.X at million we December million XXst, $XX.X XX, compared cash and September equivalents in had to cash XXXX. As

raised quarter agreement purchase through During equity $XX.X our XXXX, with Aspire. the of third we million

We the XXXX. the agreement have Aspire in not utilized quarter equity purchase fourth of

in Our burn framework the X-time some which significant of quarter, with as year In executive $XX averaged to X-time associated the million as $X these are litigation per fees and and has our million These well $XX rate expenses. with includes expenses professional X-time expenses comprehensive to range. between subsequent past $X.X the related aggregate, were severance, Healios million this consummation million agreement.

based Moving capital and up ability our rate forward, we to or our the continue to priorities have dial availability. on burn dial down

through and cash current have up balance we stands equity investors, corporate of for ESG non-financial to the note, ESG stroke whom if beyond feel companies. environmental And With our Healios the for front measure Social a a of consciousness is access and important received $XXX months. with ' we both we fund million collective of in back Q&A, to data. This mind proxy is With investors, the $XX priorities were with stasis. our prime awarded the XX% ISS, our of firm. score all B.J. well peer cash our It from Company's be turn On million, a recently of benchmark publication and and the Environmental will will group the engaging resonate top will perspective that coming we line social and rating Governance. factors. and We adequate advisory to near-term Athersys. received in an of with over particularly Consequentially, grade I for the institutional, we for call to the top-line B.J.

Ivor. Thanks,

like days and input BARDA I I questions and As our thank addressing for questions We ARDS program. many to some done about before shareholders the all we'd this your our begin, over recently the we've questions want in of received past start you over past, weeks. submitted And to period. by these by and

to for upgraded address with to its that email BARDA some programs respect guidance recently funding. So here. wanted of we eligible in has

to broad targeting as an activities immunomodulators X.X. our BARDA amended its in lung Specifically agency announcement area of area, directed updated therapeutics it reinstating to has or relates repair. interest

it Agency against of noted COVID. under would of submitted the In proposals. useful request BARDA X.X, past our prioritize area first it called is context our BARDA, Section interactions injury Amendments with therapies regarding of X.X early candidates our Announcement, development COVID. past in targeting Given caused the lung Broad at to provide BARDA, some interest proposal XXXX for which XX, by that we

prioritize about questions BARDA area October In proposal amended an response weeks continue BARDA BARDA, months. advice XXXX, X.X. we to submitted and support counsel, availability or originally Our treatment designed BAA applied to on the of that BAA Amendment on under updated funding and XX, avail. May case reinstates no had MACOVIA XX,XXX Amendment XX the with the six request within other we this BARDA in issued year. Study to suspended In the XX meantime, last demonstrating in modifying doses, the mind. pursue of and our interest In of was altogether, revises however, we courses six of submissions X.X outside in possible preparations MACOVIA of given ultimately, later, and to area manufacturing on to with experts interest Study of X.X

planned for doses program for call. the our of with consistent X agency requirements is Importantly, possible strategy, mentioned XX,XXX ARDS that the COVID specifically first may be revised and revised X.X together manufacturing, MACOVIA longer prioritizes has it candidates treatment in our revised with dropped. been no the in strategic months ARDS the for development time, build-out It

determine be it To the which it sense, close in of the a you we least process. recent And given for Furthermore, a in Several to with is to program, competitive have expect area given However, if preliminary expect focus support potential the take our a based application process would cost the a there we the given opportunity, COVID, in too as fit. appropriate. ARDS if asked to early proceed application at extent X CEO to at we of likely search. take to R&D months the sharing we increase makes would mechanism. issuance. on proceed, ARDS submissions will X play about the guidance would look the our new status evaluate eligibility be would Naturally, funding our in out,

and in substantial at the knowledge leader Athersys the to whose And beginning, this Athersys. continues our candidates environment. competitive career add stage experiences Board to very Company's in we seek have focus said from biotech As value a evolution. the hiring recruiting the out skills, for would on is best

things with to and further search commercialization. developed updates and in tires CEO We will the other for as additional provide our preparations progress information and important

in of investment medical in asked Some are investors the planning raising to or community awareness our have awareness community. we raise and how about the

me awareness let to in First, constantly say, working communities. raise we the medical are investment

On We a & XXXX Cell active continue outside attend our updated analysts this plan regards to both the coming our the out conferences, January. Conference technologies high-profile JP Gene Morgan we coverage looking for reach them And as with investors progress the on and the the present to side, them bankers to the example, for potential always meeting advisors, are we topics, healthcare we help proactively recently most our to our investment on to with introduce Therapy keep for remain new opportunities or of well. existing update social and to We media story. or Company for on and media Mesa. other

the and ongoing as continuing we've our geographic to clinical study. in on medical scientific activities increasing opportunities focused of an Augusta Chicago and side, slots MASTERS-X Recently included and television Chronicle. medical of on this Specifically the article as in recently with of addition sites. mentioned and awareness in Pursuing Miami, already our the media some areas publications, well

pieces our on viewing of for website, corporate updated these addition presentation. are our in available All to

as coverage an of emphasis will and area approach reimbursement commercialization to this be and forward, include ultimately and in we treatment pricing. the increasing uptake supporting the the Looking specific therapy of and efforts interest building will influencing

from will we now some So additional participants. with today's that, take questions

of line Please Instructions] the Our Bank by with of [Operator Harrison comes [Operator they first from America. Q&A the question while roster. stand compile Greg Instructions]

now open. Your line is

for thanks and afternoon our questions. taking Good

COVID give other trial. a First situation, one and us an focus that's on maybe know -based ARDS sense you to fluid give ARDS little you update then looking a at enrollment update Can status having the stands trials the the from of the where MACOVIA and pathogens, is bit between of And look I just entire a finish? for an enrollment? any is without to how be an on would of could there the investors wait data point but maybe give to there interim on

questions. good are Those Greg. Thanks,

any up update the that. as potential I year. current look. some address plan time discussion, more in I don't X wrap the but the for give to Cohort next our think the this " want specific So guidance enrollment possible work than and I as interim early then is to " to briefly

our the irrespective there Cohort expanded that [Indiscernible] to is long-term COVID As so the cohort patients the for X Cohort we've Cohort to really X. other the underlying through at that more introducing product want focused you was on safety. study, insured perspectives of and remember, Cohort and day, we is treat pathogens cohorts are to to X to this potential that of the X for efficacy really you these targeted feasibility Cohort non-COVID, develop X X, is X originally which larger that include some with the and and Cohort therapy end costs. strategy know consistent is

through is Cohort So XXXX. as point, enrollment soon at At to are to opportunity objectives Cohort this possible take results enrollment again, move our a X. we and take in of our would look through complete the as X an expectation

a on is final respect investors made Give these standard to for focused X decision Cohort with really treating more what haven't We given investments, on stage, that patients. not that. you the care to happened for driven design It's has confirm appropriate, allowing per information, us

think a treatment care to talked of or different stations degree standard about fair the you therapies. know, the of pre approaches new -treatment I there we to say a been It etc.. is for methods introduction past a treatment, non-invasive in I'd has ARDS of that of movement in as

which of we some of patients have time. ARDS generally Some more had impact expect treatment will success over

is make at this in we would this we the and look that So experiences part with study. study reflect sure we've to a we're I of And amendments Phase at up Cohort expect successful for be the take X. set X to efficacy maybe a III create current on or study, Cohort that true a we it point, had

particular demonstrating for about and in We the to real believe this Healios potential That's would is commercialization. very We plan. application that encouraging. has opportunities apply, a made very determination yet. the to area. PMDA application them important approval an remain the haven't milestone, the make We data mean, got I the for that very, platform the that from be current excited upcoming

the So area, when efficacy the for make want we're go we very encouraged about to the into larger set success. we're we up but for potential cohort, sure that

that's I could real One helpful. Okay, more quick?, if

Sure.

the You mentioned in call. cash burn earlier

get non capital? what to secure under you of how your partnership urgency dilutive that Healios entered wanted some readout maybe decision a stroke would a the may partnership? a - to Just been sense effect push to the And have now to a have right want does previously is to ' that that considered catalyst enter back belt before you

another Yes, good question.

I in study think I in high-value TREASURE time past, partnerships deal We've the study, the our this wait to be right. talked we results quite -- context to about our done, ability and, the the think ultimately, if wanted you're positive from get greatly by some facilitated and been a MASTERS-X from the view would very of that it's long. for that

care I potential drive a off more That it's efforts The highest for could we in to way specifically. drive to really me I So to address for say. stroke, because let the disappointing pushed critical need around guess urgency. cash value question about perceived has first, need pushed faster, the that been their off guess, it's said your our area partnership in this

that I believe a from perspective. think said Ivor we position is cash

the an Healios bank, our disclosures. on the from Now positioned we're perspective. timing for clarity feel is look that to around development said for comfortable we we're something about business there us capital, have opportunity if at a take What continue our access the specific side. And going we're where the that earlier fairly etc. to in to a we very We have to going cash it. discussions do

of whole things. Of course, a be balancing will we set

priority near As it's partner still is by create if going term, something Europe by in in plan. key than a to chances the remain in to in But want is positive it's And success. can driven driven the going explore to looking to Obviously, said at past, originally we're value. we're partner possible we find fair get with commercial we capabilities, that. find that by get driven going the best that's get be a who And a opportunities terms, of to we commitment, the data for planned. we best partner such finding we the I the had financial would opinion done end. the But to earlier for

So there data, question. press data, and continue to if to say that options we're there your a going is open, continue I we're to get ahead, going critical to where -- discussions. with we're our an the done there urgency something consider before But opportunity And to need wouldn't of to going is keep answer our forward all is to it.

Got it. Thanks taking again for the question.

No you. problem, thank

Our next question Wang comes David from the SMBC Securities. with Nikko line of

Your is open. now line

for taking thanks Hi, the questions.

questioning few. the So X continuing of efforts Maybe I your had on line a first the around the of partnerships.

any You think talked a future for lot focus previous; I about the Europe being partnerships. really

has Europe could partnership the where focus Have for curious partnership. development the as maybe geography? just wise but I'm that essentially as on help drive to and also be would giving has commercialization, a you in why been you so the considered worldwide U.S. or And up maybe

with limited to with geographic aspirations. to the many companies discussion talked We've well and continue there part over Company right opportunities for But include us Well, time, discussions for partners talked of States the and partnership the the of to broader the some about there the focus we be Japan U.S., that and sure. ex-U.S. beyond of the it markets, years. Yes, clear that is we beyond to along, have makes think that comes Critical as prepare next a be U.S. around it And clearly, Quite opportunity a the been added to the is potential strategy sector capabilities global for a course, focus Certainly, if value think the our to seriously. to and good hear geographies. it's that's question. to on that can our build is shareholders. think partner would Care are of talk we'll And of would these If With commercialization for for there allows in the has to preserves a the global with a United potential we context. around them with Europe, perhaps broader our And, the I couple a strong and portfolio on like dimension, those we we that. folks preserve in dialogues, leading sense, will consider out. opportunities part greatest involved we of an that Europe,

thinking received the the perspective the in look for that FDA? there. terms a our Healios to would of that influence make the for Does another with terms XXX-day had FDA case. of at Thanks until action And in a the their all that it a of with MASTERS-X data from blinded to as readout I being XX-day Okay. line? feedback the have in conversation similar the FDA reviewing question regulator interactions answers asking down was sense Japan course at whether

have that or would strategy with interim(ph) We not wasn't to over FDA that Healios. do announce ultimate was disclose I believe the We discussion in data. the time. the there. It about have Japan the to we'll for us. that expected have for be say able do outcome XX-day We expected

PMDA. plant the noted, approach. with laid the I very in It original as is out It reasonable. reasonable approach very submitted the was think was protocol that I mistaken

And is the We the successful supply in States. United in same there's terms think integrity protecting data. of margin via the

get have we data that with very things also data. XX-day data the move XXX-day out, forward lot saw of more to advice simultaneously than the in and the over a and we'd of a thereafter, pointed compelling even The and But going of the but MASTERS-X shortly to studies look it's impact going we at to in being it's to a a give here of us period don't quarter, have don't my that sense view fact I profound idea I the data, to bad to look is in forward doing we're outcome I And think I be what it's think the that for the get data end, to look that out think is the data. conservative. ahead here. conservative like delayed topline the the them on is PMDA disappoints XX-day data us. us time. opportunity improvement at

X does for that those create time-frame it opportunity short-time points. between the data So

data positive opportunity follow-up not question. the X XXX before we the FDA planning to are data, days weight we our think business with announced But yes, right I now that's year last strategy the the here. The from or is

for we our disclosure move of to also subject that's XX-day with collection data, is part forward. as of and FDA the protocol, confirmation and but discussions

Okay. the Thanks so much for question. taking

sure. Yes,

with Our & next now line Nishant Needham is question your Gandhi is Company, open. from

do on enrollment Thank afternoon. any updates well questions. metrics lot or My further Hi. metrics getting to by you Thank them. or I question you. COVID affected have study. is trial on is wanted any II, Good Phase for ask, a updates of environment you as study the regarding the being

area Yes. study. asking. in the real clinical of early here, been closely site but good Thanks trauma an the is Texas. cover interest for had for very working in -- also We that We've we've didn't Company. We've progress chief with made

into some trauma progress on good things is which studies. typical the expectation the with fairly XXXX is for approach with FDA to make that negotiating study. our basic We're enrollment, think about I

of things get working in progress reasonable they're which even untoward to figure get to XXXX. timeframe. that would want so enrollment. FDA the important that of to since treat ways these dialogue with what typically a is consent FDA would have an from report, is if we're the very on in and quickly an the is FDA, to as you make earlier unconscious. something about part the positive the X optimistic to and And There's well on of we ongoing into accommodation want reach them the terms involve representatives challenges an but if the possible. accelerated in done And can't its thing There's to far in or stations streamlined actually, out figure to stages nothing is legal of enrollment. been where to opportunity study. with that out going forward. asset Even have this in more to That and still encouraged typically you very study and be we of study we're as a with One hear as the season some enrolling ways you early, you sort that so

Great. Thank you.

Okay, thank you.

now to questions. the for over closing further are turn there I'll back no As comments. call B.J. Lehmann

weeks, remain of answer the we the even respond your to interactions. past for you questions your to don't provide input And over we continue and in it but the today the today. input. And on build you want business. do your our We again, tried to cultivate longer the focused the create that all task that into we your try for and you and we ahead incorporate the thank here, to we And we participation us value don't, to input and in opportunities questions to interest Well, participation all will broader plans to in term. Though of thinking us. our where month’s value in thank

move forward. As we

good again thanks and night. So have a

Thank and Ladies you This for today's concludes participating. gentlemen. call. conference

disconnect. now may You