Lineage Cell Therapeutics (LCTX) 9 Mar 232022 Q4 Earnings call transcript

Welcome to the Lineage Cell Therapeutics Fourth Quarter and Full Year 2022 Conference Call. At this time, all participants are in a listen-only mode. An audio webcast of this call is available on the Investors section of Lineage 's website at www.Lineage cell.com. This call is subject to copyright and is property of Lineage . And recordings, reproductions, or transmissions of this call without the express written consent of Lineage are strictly prohibited.

call recorded. today's reminder, a is being As

ahead. I host Head for like to please of to the introduce you go Hone, today's Ms. Relations Lineage would at now Investor . call, Ioana Hone,

A Thanks, Mandeep. Good was reflect of year section reporting on and can statements thank issued full responses earlier fourth website. and financial Please X, views press today's only, that XXXX, today and be joining quarter questions and you of our XXXX release within for afternoon federal us. forward-looking our note results today, to securities remarks March and your laws. the management's meaning contain of as Investors will the found

considered forward-looking which to during uncertainties. company's such risks the subject this The statements, and that significant by indicated made from results forward-looking differ statements materially discussion statements. may be or of expectations performance actual not are Statements should are historical fact

of forward-looking caution which report on our in results a Form SEC discussion reliance to to speak release by any cautionary are its certain and could annual place risk on only undue refer not factors in you differ, today's factors that For recent described the most of qualified including to company's forward-looking the in statement We or and we press XX-K. sections as the performance today filings, and statements statements you the SEC company's cause filings.

to President Executive Clinical turn like Culley, to Chief Gary Chief Brian Officer, are With our Officer today our Affairs. over call that, and Hogge, of Howe, us Vice Brian. Jill and With the Financial Medical Senior I'd our

one now year and year another to Lineage everyone. We new . worked Genentech open trial Welcome Ioana, us you alongside biotech clinical think an but call. successfully We Thanks, XXXX trial I challenging its companies, today. enrolling exceptional that next and was appreciate patients. XXXX it OpRegen is good to Roche our prepare for joining for afternoon, full was and for and

financially the success to which first With our in auditory adding program but improve by pipeline, in responsible existing we moves shown program, the and made bold assets candidates. our program and them that ophthalmology from from but create time upon labs, tailwinds any an expand adding experience photoreceptor financial positive neuron we've in from our not OpRegen these only third capitalizes product the obligations also on can place, is in-house which we a vastly reducing party R&D scratch

opening regulatory for a along XXXX developmental we execution also important advanced a a is as of of my investor way XXXX but a is to marked the our lot would use team presently AMD landscape, the realize recap focused successful so clinical I call, Lineage know on year pathways. and clinical better I programs clinic and respective attention this be thought that I dry remarks. the

is approved approval approvable that Last complement an FDA this with decision this preservation photoreceptor an We condition. dry change has to inhibitor anatomical treat and in form enormous a is in a precedent the of regulatory endpoint month, with the leading reverse complement the collected by FDA believe or set halt AMD far progression what greater for the of structure is and demonstrated date have been than us data the of OpRegen retinal either either ability we because outer improve inhibitors. even its to GA to has and this

we're spontaneously of these multiple images. captured will small do seeing sometimes are in but results anatomical independently only verified reporting we using number them occur patients, remind and a changes not shown analyses via these we've Critics objectively that say which I that

patients, inhibitor, Phase repeated in When the point surrounding GA gained reduction are the three to these shown error Genentech more be GA five all FDA and small provided, early on only the likely I all for a look complement drug's that reductions Roche than which area in results likely the estimates which last highly treated and which bars growth supported have believe the So on greater approval year the it's recently reported this basis studies. then I to ARVO that XXXX of which on the think trial in of at clinical is OpRegen larger patients annual for we that meeting approval. trials the exceptional

of across we outer X.X anatomical cohort who in transplant reporting received patients cells to also study improvements letters of functional XX.X among measured patients all been extensive with an of recently, have changes have only but that outlets improvements demonstrated four and provide letters five among a and exhibited XX not their inhibitor who coverage complement to additionally number Furthermore, increasing our Phase to X/Xa following vision patients gained gained the structure can different benefits retinal vision. functional OpRegen GA months a average

my The on colleague around target the XX case than data after former was at the evidence were patients less fired. call the to that post treatment which company hoc sought which they're to months This a selective liked letters patients something placebo. that XX analysis, cut exploratory likely on is make drawing arrows to provided lose

in patients for received I Despite data this on Roche and that was comparison investment similarly gained actually at by letters. will to it in number this well being the the was XX of quite community small showed didn't They patients that avoid of patients all of patients ARVO representing least Genentech gained OpRegen and which reported very only at trial, data, cohort a they again vision draw four XX five XX% loss, by reason, treated

we're tremendous benefits could to injections that condition, provided benefit, amount some be patients their complement letter have a not it's with monthly as and community of but have medical it Obviously, benefit huge clinical XX shown. the delta are a So something a to large for appears approaches. which these help may which finally patients as about between inhibitors there still which is which of talking comparisons us

major the candidate medical help of and medical presented communities for and our It's become very attributes continue investor and safety, efficacy, of important profile. the results meetings to aware our being at other product

is advantages additional the OpRegen and of potential the One in administration. product profile of dosing

involves Opregen XX giving year which after injection single all year patients month compliance an accompany than with two it. or a issues minute rather the procedure treatment every

how of we this long treatment but lasts, clear are often reason, terminus yet benefit haven't For a asked our reached indication tapering. we we because or don't an know the

patient lost baseline, in going patient was mentioned still who prior which cases, her calls was she level with three way years as eye, long five has eye. her untreated four first we improvement that as I've have the eye higher of XX than her data treated letters our her some including in letters very by at years acuity baseline in better visual structural on out after performing but OpRegen

still Again, Phase years up four is X/Xa be follow and data from duration study us Long-term to from treatment a come more which that's month. as the to in next disease post-treatment to analyses of deeper which coming progressive. of may continue monitor there the inevitably allows widely is as ongoing, effect well viewed evidence imaging

just Al our to are as next this ARVO at XXth. of be be Phase a by April of disclosures Benin updates in and few trial Dr. one on meeting always, XXXX happening Genentech look annual data will X/Xa and weeks. Some That'll behalf Roche on data made important forward the presented available and that from we

outcome available study as two data predict the has safety trial an usually Genentech we're have to for of patients, the measures AMD well that will is expect all OpRegen enrollment from has XX we ongoing secondary Meanwhile, to days, Phase occur that period and to about so but compared brief Roche very XX delivery techniques. dry evaluate and the is excited studies. will a study when because range of the It which primary activity launched as at certain difficult primary XX what observation to it regardless,

continued appreciate clinical trials Eye former enrolling in of more of Genentech Sacramento, Cincinnati study. has we Dr. retinal the be is Cincinnati patients PI participation who our Institute one operation a we the site treated Dr. the participated sites in Lineage and and year. Reman, and this online original and whom far T PI both the disclosed his from X/Xa coming Land's restoration so will sites expect Phase in Christopher two

our completed as successfully on lot of support you'll our program, focused to spinal which cord a one, work activities last to year we recall OPC planned. next that regulatory Moving interactions for

the response following Our the previously data support conduct which an have requests and for and and in I package several our dialogue we interaction with FDA on RMAT RMAT we chronic small subacute a of with use been additional device for package along information comprehensive have been patients to have delivery initial FDA submission. responding to clinical an to active discussed occasions, study plan safety synopsis was protocol to new with a the to submitted

with type hope occur quarter, anticipate amendment of in We B to another submission in planned our will support FDA I&D of this the interaction half second the meeting, second year. we formal which a

our necessary either received, able. as with open-label Assuming injuries study XX subacute we're clearances the plan to safety the as chronic is in dosed study the known device to are clinical soon patients initiate five or as

continue Institute also Medicine safety We and study. the to grant with to for apply the frequent Regenerative to California support contact a we for in remain device plan

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manufacturing new we currently and from be hope appropriate data available. once preclinical line studies top patent as to program present been and also are photoreceptor We've which data Initial preclinical in in ongoing become vision to our made of both programs hearing year. the were and for have disorders, and to able last our two publicly engage launched preclinical continued activities transplant loss cell submissions

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platform money the from making our differences When increasingly small capital striking and return the we against invested the our invested I same We a compare untapped industry think in become programs improve apparent capabilities Lineage tremendous has new the we in on the to a that and norms to it'll continue potential. homegrown as vivo and advance find journey. further, move concept into we for time testing program molecule

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could of an appropriate beneficial consider we product new the ensure to expand and and whether our suitable be all product have commercial an product we need other could We want immunity feature of to our potential interesting areas candidates. that to think immunity hypo If technology profile. body, hypo candidates be for

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to new can company. we in arching where have cell existing overall have milestones of settings leading OpRegeneic we and of ensure important and I exceptional our programs the XXXX of all in a remain on help cell disease responsible the we support efforts company believe additional a events. in and during in capital believe all building progression XXXX. impact continued prioritization into of making further investments the each made Lineage focused both therapy We'll To our therapy and progress vision our meaningful reach collaborations

our a discussion of call that, the I'll over now to Jill With financials. for hand

to spending Thanks, balance Brian and the with everyone. which afternoon efficient with we near sheet, conduct Beginning I to our our continue believe good be capitalized Brian, just our and well outlined. activities, term

of operations cash XXXX cash, is and $XX.X our of XX, to reported December as into which Our planned securities equivalent QX marketable totaled support million, expected 'XX.

note may period. which business we milestones this for for the we during revenues, Please any not receive, account any nor development does grant receive same may Genentech or of Roche this which

quarter an start overview Let our of operating with results. me fourth XXXX

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were and the million expenses as in the was XXXX. the collaboration. the a early for $XX This accrual by IIA prior partially substantially offset The seat to with of quarter of connection programs $XX.X $X.X year same therapy development XXXX obligations support million, and Roche driven $XX.X the in financial payment for to payable compared had new $X.X in expenses the neuron million the receptor R&D under million $XX million respectively. received the decrease for by auditory fourth $X.X million cell to decrease photo was a decrease million upfront in and period

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or For XXXX. $X.XX $XX the applicable or a loss share the fourth for period period, to the $X.X loss same net per was compared in million million per of share net for the quarter $X.XX

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compared same the million $XX.X million from recognized to operating same for million of the payment the collaboration. primarily a $XX.X increase increases was from compared the Total $XX.X period of to an Again, $XX expense to in XXXX. represents as $XX.X $X.X in revenues the related for million XXXX. were the million, This upfront the for period year million Roche decrease

accrual payable R&D Total R&D in neuron and $X.X same financial as a XXXX. for $XX.X the by of IIA cell year to offset by $X.X million decrease to to million obligations decrease see million therapy for spending $XX million, substantially partially and photoreceptor The programs the the how prior on the new $XX auditory decrease and expense million was compared the year. for period $XX.X million was respectively. was this in driven

primarily GNA for increase same $XX.X were to decrease million million. litigation expenses, a million Losses legal as in period period $XX.X from $X.X salaries Total compared approximately compared The year million in is attributable related $XX.X same $XX.X XXXX. XXXX. and in year fees share-based the for million million an the the expenses. $XX.X $X.X $X.X is million in for the of of expenses in operation million, compensation were for to to and benefit and million $X.X increase This as

million for expenses net and compared in netted period primarily The as share million income million XXXX. net loss the exchange related year compared the to gain year fluctuations net same a per on international equity for of the $X.XX was the other loss for subsidiaries a well an to prior to $X.XX of the sale $X.X $X.X marketable our variance for of expense securities For to or year was million income per as ther of rate XXXX. or related applicable period, $XX $XX.X share

which our discipline that the has our to markets shareholders Overall, same that we allow past. reach us milestones for served continue to discipline well adhered so uncertainty, the meaningful to to The we maintain to intend in our value investments for spending us programs. maintaining spending have believe continue with years and we in from face to maintain and plan their create will biotech

back Now, Brian. let hand to the me call

Great, to environment continue back in I of is the beginning quite that thanks industry. the strained Jill. biotech call, to doing Circling Lineage this well think otherwise an for

our to responsible and been this apply in continue I milestones the our Jill year. and way, expect programs discipline a advancing We will same to I financial have and hitting and positive programs our coming

with us XXXX helped Roche, to further approach will it believe continue valuable an land during important collaboration Our and a I be out. attribute and

number the success demonstrate potentially support, clinic paths. non-dilutive accelerate attract have we'll in or across programs in parallel our opportunities I believe preclinical work and additional of our As testing a to

of speaking, updates Broadly want X/Xa returning Genentech, seminal being year we the the additional the for could a on conducted the OPCX, results for Phase X/Xa not for be and study to expect OpRegen but watch of GA event conduct entire also Phase this of few the field. Lineage by will things second we be to part additional this a from only which during our progress trial working month, may believe to quarter OPCX you support which which data support Roche , on be next of manufacturing. clinical we with which regulatory in year, testing completed OpRegen, we'll include And doing and will which we'll

exciting can combine planted existing our course the in of we've the furtherance our new of disease programs goal of to prepare addition, change access of a seeds to option preclinical internal Cells future, we Whole and with new using new the the and gives technology, capabilities deal, which our to for us few which the affordable transplant in In ways. including

analyst there any And respond with that that to be. Mandeep, we questions to ready may are

Please the proceed. from Baird. [Operator line instructions] question first from of Jack Allen comes Our

did in made news with dive the great team so on Brian, was recent over you thoughts of congratulations on the if the, heels progress announcement. quarter. around your could with laying Thank a the conversations all the the you of course of your job you some the you'd Great. out geographic some and Roche I atrophy, little deeply more the this of bit have much a wondering partner into but

Any to soon more sense as, see did quick I as how, but the how feedback ground I'd to any data? could comment And it as a love said on there. make we hear you one follow really earlier, up we'll? know then I have as

Jack really The will it. think and and clarity answer Yeah, makes I data occur, it expectation when, question. shortest challenge provide major the opportunity suspect that as to more public of The, But might so to difficult disclosure XX or, an enrollment meeting where closer possible in the add. range. to to thanks, the events the how in say to around I is medical that no, XX be for nothing we biggest and is we whether event pieces come it'll forth. get those do or that Being

become of Great. seen least to medical on was the and preclinical more into could it if some it's And been sure here, hands had and any here. of from bit wondering to non-human suppliers hands from it, some space. get it updates you news I'm other my non-human box little get out not relates there? Great. a pressing as use of to at the the hard activities your these comment or valuable of you're primates the the some the question your if timelines players that how coming but factoring I primates, on research the and, then your you've assets given of in

great issue we do challenge, we but that morning at them. a not is was deck so reporting it, that they chance, do NHP by susceptible question. I It's a a, a for of if company's to haven't early answer the I wonder of it and were testing, it's occurred primate It's lot to not supply similar slide a and looking this for and that data is not an me, in non-human any us. Part we're noticed

have, ensure any a began, company by don't preclinical it, species. NHP particular to that being to in that are our we activity way, act since managing chains don't how have I multinational know excuse ever supply order have benefit and but Covid utilizing that others are any any, good worked a, that, clinical in me, we but we specifically we

Our a from B next Mamtani question of from Securities. Mayank Please comes proceed. line Riley

off loss as able new you've bit, from surrounding us. results tend the Would We're follow little it'd how remind April. already with long that that be treatment. visual be, in this far correlate or, opportunity anatomical up acuity to us your but incremental or this excited Wood as Mamtani Hey, you've what or given work. see obviously OPC pretty is BCVA on progress Brian, clarify seen of in or data Congratulations, your forward to been then now on three and And this of a, to ARVO see to upcoming of to you've be William you a also terms making you today. maybe see the Mayank of, any to you've all greater rate to here to of the had team. know vision great got I XX lines, partner cutting Couple value touched excited a looking and information? by is upcoming per Really the letters have to hear Roche the for we questions or than might

hand going Thank to to Gary off I to those. speak I'm appreciate questions, you. the to William.

and is there's time. we, in thing and, that throughout obviously which and and is, The population that we studies. the a lot those is BCVA the involved in news so examined and, good cutting applicable of buzz looking loss over Yeah, around cohort is it four, closely at the line three

so of MO analysis any acuity and particularly that we that's into patients, at loss the those focus those three and time intrigued about. data the line patients on like, coming know. we part had we numbers four reported signs be For something Smaller occur the that improvements to structural observed haven't those it assessment the retinal But tie they that of and that, over out auto a on visual cohort of OPC visual maintained in looks how ARVO how certainly in and will different improvements, at changes improvement. quickly up looking showed we've

have analysis. we're an very data entirely independent again those to so by presented And excited

the extra there? also, since may that clarify, And trial Appreciate you the status there. timing ARVO release you do know then a And abstract that sites expect color of just in PhaseX the of on to whether overlap presenter enrollment comment abstracts? the meaningful then there's

the, per ARVO time. be Dr. Benin that's or I offer regards two at week the early the comment able don't so Yeah, or to additional ongoing ability to sometime will Genentech the on think perhaps with and any he'll comments study future his website Roche, be in by conducted to available this next so there the March

we I'm ever putting I'm on X/Xa, this And William, the planet receive spot, general going add Roche the the people experimental don't think to but XX to here. first running therapy. when were on as matter, I a were Phase the these

in trial little could might they conversation prospective available, actually Now think on a safety domain. that some the me and that makes basket patient the, is between there go results the a of in available a are it differently doctor because show clinical efficacy data their and that public the

when than we but hopeful, were am it. the that I go running hopeful specific I'm enrollment is just no information will have because trial was it So although I underway, faster

administration. know And what a them That's a Got switching In but inner plans really one you're one, think the to the be just p a regards and just walk implants, I incorporating the good hearing one, gears. could your mentioned number there's it. of ear. going that. through Maybe intercom your sales space, lot that been be plans you've last a combo I obviously I'm delivering curious to of cochlear your in for players helpful. limiting don't then into it to on there? us are

be we way the me good have describe so but I, need to I a, a to for ideas, Yeah, what that think right they of tested. lot is

what exactly patient loss. about more intended application There the of position we're in say or causes so And will many not clinical today right be. are whole a hearing a to an lot population

at and We're that follow process. that's the very of collected, the going we're to right earliest now stages data just

some be think the best So I and information. what think that it's, to, as to when we confident sharing look we are something reject options narrow some we'll that do forward but reject in approach, hypotheses, begin it's to to will down and feel is we so able difficult,

comes proceed. question Kristen next Cantor of from from Our Please Fitzgerald. the Kluska line

Hi, afternoon. my questions. taking for good Thanks

time you the emergence from a a lot a how I'll How different market, GA that frame educate of think by in help could help but talked complement we've these the to approval you better question patients ask general OpRegen do the inhibitors So direction. eligible about the perhaps commercial can

reaches the market? potentially

shown they eligible. legal towards I know far you've are blind too So may that along status, patients not if be perhaps

do given So on some patients, should they eligible progression? of become at you think be compliant could least complement that there's more these inhibitors, slowing the

I love it.

new therapies a accept there I people couple a this beneficial. to approved can are a be where condition market We And to is there are going that where technologies market There leader are that places think disease out an a helping therapy earlier. identify there environment in today. no to are that have

the patients increase that more for that see think think going earlier we're suited condition. companies in of of in I identification And with to aging the population therapy. these of are sort patients. an development increase are, also through is the going the to are I And I most therapies think prevalence So incidence thinking

we're when you a that you, and caregiver, we with specific dry nothing little would Mr. brought would population. my have So he been for if you, there's a dad he that do in, on now first be Culley. now But presumably told, diagnosed captured AMD, be of if therapy, a he can would would've a imagine of bit sorry, he was he's

you if or population. treatment disease with awareness setting in patient you second, third, from an and a educated So the benefit in, precedent fourth along come a, the the of

then if it therapy a different I'm continue to therapy, look but So we too so wildly its would terms hopeful about I of we'll I me product so feel and had because is our profile. different and, not so in positively

positive it's us. think big for a that I actually

your given of wondering Genentech Roche, Okay. course how and as the here. pathway earlier work the from I'm, validation data you Thank of here with about do you. some the, some I'm to this thinking you're And candidates start

seeking can saw proof in in-house then like establishing term? some detail you conduct concept to work potentially similar for data of you potentially you what So preclinical the And to do partnerships before of your here? us you're some that intending

to is very it, cost the think on I with, of of partnering, the respect has the development with you're answer question, to strategic with it facing. that much So component do your depends that which

your probability success, macroeconomic you're of capital. environment of the Your cost in, business

assets are fun All multiple of decisions get with sort these companies make. to that of factors

partner have our So a or to partner plan assets. we don't not any either [indiscernible] of

people valuable. capabilities And valuable. have rewarding partnership We a make try we and and and are valuable possible to to have We be that be so them increase probability flexibility. elect who to if and And financially that that can as going just look the capabilities partnership that at people strategically with means we find assets high of rewarding optionality increase into do who as enter means them and have as partnering are and high that leadership strategically to that partnering going to success. financially with

and the I I an continue do had that that far, think with from success believe that OpRegen approach will the we've so

the a are will there's different a beyond of borne setting believe out But of and are the is we that assets. apples of not on AMD working that and dry in think small we apples program things other cell to does we the doing reach amount in create certain so molecules being notion comparison. are halo settings. types, be of conceptually, other a is notion capable a with effect Clearly, applicable that perfect cells

severe, pathway and spinal entire approaches off, is has an was to could sort -- pure cells accident cell to a utilizing I successful. reminder injury. study aren't dying getting scaffold. that not of biologics a enough field a Unfortunately the that But the the spinal that or was no particular refer the were trial of after goes to that scaffold. cord quite morning, standard again, another trauma, the sometimes level there was cell condition when It injury unsuccessful setting it through was There of involved. beyond patients of of this case been the some are or a destroyed single just And for the expected just as or case the that in the in or, strong was cord far very in me, is sometimes as such that

comes line HC proceed. Pantginis question from Joe next the from of Our Wainwright. Please

afternoon. good the everybody, question. Hey for Thanks taking

I your leading you Brian, mind. don't VACX, on two So wanted to and discussions with regulatory if focus I'll start

the cells. obviously pre-IND as you well surrounding are now talked about processes right the characterization So production as of discussions

those So how curious, doing? CRUK any, do what I is if from was differ, processes

Thank that is that a own in sauce you but reasons size demands we for those everyone the to types. would the, different an process secret ,so we apply they I they, clear that the to option fits the its and really we manufacture one listening of differentiation steps to that Joe to that exercise not all unique improve we saw be we want type of, the that for cell similarities question, have one exist, cell requires try I do each say of that processes. upon opportunity set

in that manufacturing we really that we out want only so to get a used to it how these desire cells the effort clinic. to be way is It, figure which laborious in the cells, to behave the we're

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I turn like the Culley would for to remarks. call closing Brian now to over

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call. today's We ladies and your thank Thank you gentlemen. participation. This concludes for you

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