Lineage Cell Therapeutics (LCTX) 10 Aug 232023 Q2 Earnings call transcript

Welcome to the Lineage Cell Therapeutics Second Quarter 2023 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.lineagecell.com. This call is subject to copyright and is the property of Lineage and recordings, reproduction or transmission of this call without the expressed written consent of Lineage are strictly prohibited.

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

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

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

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

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

of Senior President Officer; our Chief Howe, Vice Jill and Financial are Executive Gary With Chief today and Hogge, our us our Culley, Brian Medical Officer; Clinical Affairs.

turn that, the over I'd call With like to to Brian.

feeling A things continues excited happy to I on time We a very business you the items I'm the I'm to be future. join good with to has to development many will us everyone. reflect its about today comment afternoon, on you, that how that lot and plans today. be are good about and appreciate Ioana the reasons track Thank of that going. share taking

on In to our program. recent AMD dry lead with see I space kick developments going I particular, and affecting usual comment the to off positively as how want OpRegen. I'm in events those

doubt recently AMD. use you to Syfovre, agents there atrophy aware, dry to been have the FDA-approved the to available issues first disclosed As secondary of no treat are safety geographic related

on these because I'm is am it cause only going to that is exactly safety of evolving, root highlight small rare clinical side thing product a the benefit. issues but can of still the but effect a speculate not to story that sort a the going derail serious I offers when

that best, know, your XX% any a As expected shots GA all at we experience of may you receive clinical growth. growth compared all in your reduction actually if given with monthly you the in about shows inhibitors or see complement to-date monthly year, a to other

it lose differently much debate whether taking And clinical in enough terms patient of and would are feel your have of was experience, unlikely to other is a in you about which marketing to there the condition. be benefit you why launch due, to when the absence to continue need course, very vision, to any unmet receive the did it of successful was authorization choices, this going so early approved. the signs there product where be the and and high But

whether limited Achilles which risks overcome so up vision from small are utility of you're with its the given safety drugs benefits When highly rewards small the patient, and prescriber individual stems years require observe, perhaps even risks. to be launch or on rare while the its clinical product, benefits clinical was catastrophic the being to end heel demand is be and benefit, But the susceptible FDA, can and can initial devastating of issues, to an highlighted side its the a to loss. a compelling, the Syfovre exists it's extraordinary of enthusiasm, effects a which side, unable may drug

While rather product but must a its benefits, is on risk limited outweigh risk, which not small basis, this to for absolute the case an use that the appears risk.

capable of But vision. which I small more think approved and vision, the if vision key bit risk a the of that takeaway unacceptable driving preserving about incredibly The deeply years prescribers that losing clearly enormous games the of until be product a risks. even may remain is is for are hope the is market opportunity both worth that is demand. even for to patients takes care so several unfulfilled achieved the

investors, finding effective story chapter safer, the or AMD a recent think highlights ideally most Overall, dry three is things. means that more therapy, in this For both. which I

has an evidence it level provided of First, opportunity. prescriber enormous market

loss vision the validate were to was in to projections impressive of widely commercial held and sales risk the Syfovre helped AMD. vasculitis early disclosed, Before dry due of

are the prescribers which for by OpRegen clinical More be you've trial more exciting, effective need despite achieved needed. effective the who cells substantially and area temporary thought solutions. across patients you're all and on of calls, single a approvals heard surgical administration. now benefits, incomplete were Second, complement continues talk treat also unprecedented if our with candidates in Izervay, a of regular about to received to and AMD. infrequently GA me dry inhibitors and and And of these we've X/Xa the appear heard Phase Syfovre These dosed there that leaders be a from to agents

increase in treatment into doesn't and with progression, beyond slow programs, a stop and proposed product with acuity weeks look first-in-class agents years. cases, first-generation a pipeline which in an reverse can, best-in-class so starting GA potential merely to lasting patients Lineage such the even visual ideally some the dry for profile, believe but recent we in in do or begin and positioned with candidate approval and future of of is investors AMD As

approved more its easily larger product has events. risks, we every of While adverse would significantly a frequency benefits a believe a commercially and clinical tolerate benefit low agent risk with

were clinical is the added they right via embrace our treating inhibitors, a experience to makes move extensive assets development to and approach we this has The treating it discontinued. agents but Roche signed new that Roche clinical with I complement for highlight licensing on When Meanwhile, deal with OpRegen. stronger Roche potential benefits. completely larger feel about pathway GA the us and with third complement even was of those partnership believe Genentech. comes from to GA, the

previously, shared yet I'm I've the provide patients. but reasons able Roche enroll to to trial For OpRegen, not Xa of details Phase about continues ongoing

behind Roche nearly are this additional a each As XX year, reminder, expected and enrollment can has which sites at just to them following come primary the follow quarters you days endpoint occurs clinicaltrials.gov. two experience of transplant. online

that we top also is which and will the deliver upon continue X/Xa able guide that easiest will in hopeful Roche able with to data when they be line insights safest reproduce show, the reported early Lineage our I'm that way OpRegen. clinical build trial to not additional into to to data to available, Phase success will be but the the and benefits,

our Spinal Cell program, This to discuss expected, we OPCX, our the recently from next and B response Delivery conducted Moving clarify meeting new Cord submission we that to submission. received Device. a to was use as Cord Spinal a Type FDA of

agency we conduct based today, additional with of back-and-forth with on I'm the on this response, that pleased content to not to topic. do the that need you discussions share

some IND that in this and the were next system final to and amendment response. the submit new step, requested will that through we Our content be FDA's amendment, to be for will clarifications provide permitted

amendment acceptable this design IND on that that studies submit agreed agency OPCX needed. in-vivo of to the trial, In fourth the The additional clinical would remain said, technically on our non-clinical also quarter. seems track in proposed and be no light feedback we the

will that patients. clinical no in in that us bring testing, Assuming proudly back the and chronic the comments further days submission OPCX arrived initiating dose permit study following to by XX into subacute

investors, and briefly Clinical organizations, provide they alongside of corporate a participated SCI and members people the which event the who analysts therapeutic public follow-up media experts, Cord presentations advocacy Related to to created Injury representatives, individuals have discussions, together heard first Annual in live and like Symposium, hosted we see on Trials Spinal and panel in with area trials. OPCX, brought researchers, in June. Investor would to future I the and experience, from The we and what caregivers, want

has how representatives begun regulatory next event have inviting this from been beyond far already expectations, about, by we to can including year, it and response agencies. improve thinking we The our

Moving received next the UK-based eight were in enrolled X VACX, with who cancer data lung recently on conducted we the cell to by patients trial UK. advanced Phase non-small Research Cancer

generate progressive and immune and a those robust demonstrated the of three, response of expect Five a designed immune-related best adverse The data be treated from that we most appeared notable ones points modest observed well and we eight which from response. candidate patients product therapy disease. and patients in immune-related stable were disease; VACX to tolerated the to events were all demonstrated the durable

against ELISpot had segments the responses assays cells. and patients tumor that allogeneic two onto two responses loaded of telomerase durable the which antigen, others indicated dendritic had has been transient

a this UK data the As and two-year Cancer important eight the reached connection cell trial mechanism trial. provide address and all of mechanism affirms potential efforts between to types whom this appreciate and this clinical had in for refractory whole, study. was efficacy of Three an the was and observations of while cancer. to our the proposed VACX small these certain data, belief survival patience disease in We allogeneic the important assess overall patients, complete And the and tolerability to safety was their which sample, a an of endpoint. the at the therapy for collected, Research the This team

alliances development the allogeneic advance continues assets. best path antigens our platform and the dendritic our different VAC employed in of of in engaged way many because be terms for strategic team us BD we our could offer VAC forward, to discussions cell exploratory to system, In the believe be

space. While to not there fruition, in the recently will we exploring come clinical assurance any been that neoantigen have no results partnerships vaccine encouraging is reported we're

path talks, to our strategy landscape So in the determine to for help VAC we platform BD to which may the continue other corporate development this or pursue. inform monitoring programs, best and any addition we VACX intend

to received that as just VACX the others have well be development Lastly, I eligible for as could that we information, avenue, indicates recently and mentioned. funding which serum begun evaluate

For preclinical collaboration of cell is is ongoing ANPX, testing which loss, for program a hearing our Michigan. the with transplant University through

those lung from our anatomical survive I year. of after transplantation myself the objectives in always do evaluate this been program destinations to collaboration to the are engraftment findings but this this initial on locations. an how from can cells the Our and don't plan later assess cells update study this to today, on provide encouraging and have we of ahead initial certain get

to decision have seen, We believe platform year. just you these hearing And the that validate space making loss loss days AMPX loss. of expand loss the acquired, gene another for early-stage will acquisitions the program. a few recent to some serve provide past competitive hearing to was therapy our As hearing company hearing in Lineage may into ago, the comparators acquisitions in

kinds I've patients defect. cell as this therapy previously advantages specific to certain while because cell, said, entire of And select one-and-done have gene the larger markets, cell I offers of replacing the therapy gene advantages means We can matching treatment schedule for you think a addressable of don't therapy. have think therapy, carry who genetic over the

to the So want a we reproduce be I at value will to retinal for to create wrap for up in will which ways of of I findings the investors this our shareholders. of structure. is working Roche part Lineage improved believe few the independently one whether of near-term call, the moment questions mention

support doing be and will help to their So everything that we conduct efforts can to study. we enroll

awareness and overall will OpRegen development. employees OpRegen them, In And be working which plan manufacture be thirdly, we is this which expect process and enable to data transfer meetings to program additional it. to our always continues the OpRegen Roche I/IIa our Phase of to the closely in-house, to medical updates of year, production to Genentech for partners' them from for increasing helpful part of with commitment presented parallel, to demonstrate at be we some our study will which

the getting end amendment pipeline the OPCX most will the our the submitted item be before year. IND of respect for With programs, notable to

reach areas other spending portfolio. our while across we we from those to make milestones updates try lot milestones, control. our from always business, each progress have as reach a of to newsworthy to under also our keep do try of very expect also and We aspire quarter hard to we And

transition, a as now a to the financials. our serving over Jill for that, will of with discussion I So call hand

to with outlined. Thanks, Beginning report Brian, near-term conduct Brian and smart everyone. I'm we our continued to balance just good pleased well have our spending are and capitalized with afternoon, sheet, to activities, be that which the

which as amount and totaled any for expected current and of grant for or is $XX.X of Our plant receive fourth reported cash, payments cash quarter million, XXXX. the may into securities we note, revenues, the June of period. this marketable development does any not XX, equivalents Please operations XXXX, to cash Genentech milestone account support same business during our the Roche which

Next, quarter operating we will review our results. second

and million revenue by XXXX. million, to is in decrease was collaboration primarily from for revenues the Roche Our Total from million of revenue recognized a as net research generated decrease primarily $X.X fees, revenues grants. approximately and $X.X royalties, revenues The from compared driven were the $X.X agreement. period same lower deferred licensing collaboration licensing

$X.X increase for million, of decrease development operating administrative of period million $X.X for and program-related general same $X.X and in expenses $X.X primarily R&D $X.X period research net compared higher program. and $X.X million Operating in million, and this expenses expenses the $X.X the And expenses a expenses. million same expenses to related support XXXX. are million by driven of to a $X.X XXXX. OpRegen a Total in in to nonclinical as the as were is million comprised increase compared OPCX expenses were million

in the stock-based compensation This decrease $X.X expenses parties, and services decrease million million for compared incurred to primarily driven period for G&A litigation XXXX. in of related million, expenses reduction $X.X the $X.X overall was a costs same third by and were expenses. legal in million net and consulting costs by approximately $X.X lower

in securities in and driven expenses the by to changes our securities. period included related $X.X This from period of Other income same $X.X million, $X.X the rate other exchange $X.X marketable XXXX. international marketable subsidiaries, interest of of and to was expenses for an million was $X XXXX. expenses increase income million market change primarily Loss debt for compared as fluctuations from other our million value compared in operations equity fair million to same

was we the have or $X.XX in well spending per to or same $X.XX in loss has us $X.X to the for our loss net years per served to compared million The continue net share and as past. a share maintain period XXXX. we Overall, $X.X million of discipline adhered which same for

to spending to progress discipline our uncertainty, will our from plan for As us their investments that we to the biotech markets meaningful shareholders continue make our believe and important of continue in to programs. maintaining maintain value milestones, face reach allow create

call me let Now, the Brian. hand back to

pioneering has few analogous up, an which but large wrap commercial we To Jill. Thanks, opportunities, believe Lineage competitors. is approach,

stem therapeutic thought already by generate types, certain cells kind While starting were as using best to a as cells types, may do the to represent cell have in but ability themselves, generate other exceed shown clinical vastly can them from them and cell value to isn't true outcomes once reality occur efficacy that new powerful not of in and which stem material using including cases, the chance of medicine, and alternatives. that the available the be

found disease, medicine. GA achievements X cells But reported oncology therapy approach in success the in and our in with stories the maybe as Type cusp as in or the an can application such in suggests tools, in best diabetes non-cancer data of own indications dry recently understanding of replace that restore be as AMD Parkinson's cell exciting of Most well and to-date and era. differentiated a advancements on transplant

biotech challenging conservative advancing environment. way. we're disciplined responsible believe in Lineage in our programs and spending, with and is We've to making decisions a continue a good I been our

to clinical year Roche support And to OpRegen. development Our particularly work will them be with of will in on of the things one collaboration be progressing extremely further and Genentech is this the we well. excited continuing

to as and cell we the look in your As always, become therapy transplant appreciate support Lineage to leader of the sincerely cell company medicine. position we

I And Mandeep, questions. with are Jill, that, to Gary and ready take analyst

comes now your ahead. questions. Jack Please is question go Instructions] open Allen floor for the of from [Operator The first Our Baird. line from

more enroll the over Could Great. course the activities do it's their the to trial? lot possible? the aid OpRegen. to you this about you Thanks study expeditiously execution opportunity progress hard help a speak made about quarter. you know with team start, maybe your the taking talked time little can but to GA a for question. I Maybe know, about the bit of any on Phase all you can Brian, do finally Xa as to what I specific help in to as talk partner lines, of this Congratulations

we limited relied on used can It's specifically, same able when to-date, which Genentech that clinical is I'm the centers, share to X/Xa I Phase has but what in note had the study.

certain contributory relationships characterize nature could respect specific understanding would more not with frontline to perform, the familiarity that we that contributional and But there's those I activities So, decision-making. be in much beneficial. as the know-how, or as

And paying the studies and OpRegen is Roche as study conduct. clinical which you development already future this for know, any in they of

any So opportunities is of contractually us what we we OpRegen for any program. but the helpful the furtherance try don't burden, beyond of to the expected in to have in actually look be way creative of to go

here? dose talk OPCX a about Great. new hear I you hear here. for as it's Great. OPCX, maybe bit back active to and you're were maybe guess to amendment to the that much maybe It's about more understanding as you then my and great IND an your talk a and planning device Can Thank the -- longer-term you've maybe the so you a with you into can little can patients to larger X-year device study. few a on this least to step aspirations for little that previously, from FDA bit And forward. that feedback plan going move X- role gotten then the at with the great asset active or taking color. that quickly, helping very in implement you're progress

question, to receive to intend outstanding is and can which we and if conduct what OPCX, is In order they The will determined. study a which oligodendrocyte want that question It is need larger benefit we of it. answer to design premature to The manufacture. the we most cells, which patients controlled answer the of magnitude answer about enjoy determine us important study. not has to and been

of a conduct larger we there want to However, complete are and that are study. prepared couple able to we steps before that

easier it demonstrating you're beneficial fewer of even new which to system. deploying One perhaps we utility It's think administer those be smaller, of, and on and safety parts. the delivery will aware many lot a that and of It's efficacy. is well the has advantages component

to thing introduce new cells, second The that at which we need Lineage. to is do manufacture the we here

As When you control -- are aware, and talked manufacturing made believe and would this. with go back to achievements I propose they I've on that's have the scale, and about are the team and OPCX elements in of those the be design then study have complete, others and purity. larger two the we manufacture to of FDA extensively with where want reproducibility, we really a of that able the comparative terms the so to the the forth

can spinal gain is would which cells help this but that cord. cord a clear receipt when they for mobility straightforward then otherwise answer relatively We of critical of get these we hurdles. conduct think study the and to to after that that therapy not is, And to I experience we would are larger couple question, injury need a their spinal what past want a that those, individuals

on much progress. the so for you color. Congratulations question Thank and the the again Great. all

Jack. Thank you,

comes of Wainwright. ahead. question Joe Please the line from Pantginis H. from next Our go C.

afternoon. the Thanks Hey, taking everybody. questions. Good for

you and envision between there question, is Syfovre? but intended, OpRegen Brian, do or or first pun I my complementarity [indiscernible] So potential any no promise

one talk my our question I've the that of years how and going in them. to the heard could is a to addition instead five jokes or certainly a be I'm to complement in of therapy about and here Gary lot used to compatibility refer of vision inhibitor.

Yeah.

a on Joe, of unmet for obviously, the Syfovre, clearly, So based launch need. I think, initial huge there's

the And no can space. be reason there's used allow the used in and plan agents be two OpRegen a big complement that first either or complement inhibitor, a conjunction So the inhibitor approved versa. and in vice co-administration. potential that both OpRegen that with think We up a two might technically, they there's products, effect products, of follow three from that effect then with benefit synergistic

both but think if at we'll obviously, to coadministration it approaches it studies dry need don't AMD. conduct point, will anything, benefit will some we impact to -- So treating

Thank other and doing should the inbounds view over And to helpful. guess, of VAC sort to it that's platform scenes wanted are having than platform. a how No, as of switch you. you I or platform? I behind concept what then the marketing we percolate to sort the

you their situation third-party scientific able to able Do help the it? is Are to percolated. hand do can where potential to be platform being any experiments? NDA have and be of So, to you particular cells a sort doing out work an market how the own

a is it is prongs. viewed answer The that of being number different through

pan-cancer combination of has cells. use you from one for about could can surface like the that more patient which or antigen another TRC of you be different basis AI centers with thinking would and imagine purpose some individual done machine working again, are an this of broadly. to range field antigens, the imagine the And collectively work use more to a academic could that idea you discoveries of serve So, those might of that could of on coming could for at learning the the or rationally either on out that the party or select been antigen harnessing presented more dendritic be antigen a that antigens that

the as dendritic dendritic we cell we are of first to which prongs think a the costs from which other essentially the beyond prepackaging that production improve system, the have immune We cell. the into there's cell a of considering, it because clinical include that be antigen step lot the dendritic is room system. the we viewed drive manufacturing. the and goes can We there a think are a tool perspective, with And still that that prong of down is

the be concerned right nanoparticles designed in prongs antigens those those not the previously that for rather way, system is all tickling So, utilizing lipid if their could than of is immune or presenting your beneficial. of individual antigen difficult permutations. tackle system with you to extremely It nature's quite all are using simultaneously

and the But having with say and in thinking visibility beneficial are the derisking elevate and various each that with exploratory partly of these of be in are BD that parties, isolation people about could I talking kinds and they when prongs conversations, that have the about which then supported the partnership provide some lineage. and partly help altogether importance of VAC program could program supported multiple approaches, by by which by us perhaps

Appreciate a the lot. color Thanks Brian.

you a Conference. and Thank and at you you, and Joe, -- cord thank Spinal also moderator appreciate Annual spinal participating that for as Xst We Cord Jack others.

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

Bouvier Kristen. on Good Jason I our two have taking Hi. This afternoon. is questions. questions. Thanks for for

Xa are being how enrollment by the question Genentech. of thinking subjects about the not information and on that you is number projects Just have And managed Phase second to programs patients have Thanks. earlier-stage rate going the yet are prioritizing any of the enrolled and many in trial back left? the or are you sort that Do any out been how potential pipeline? of

certainly are failure. success, is balance for level lead presumably our just to kind other I disclose with of is planning will the call to one planning their projections. enrollment, to planning that for balance and trying what for unfortunately, need permitted between are With to success. and strike one granularity respect not If to own We're share within that we or isn't a we that will estimates balance, and everyone, you programs, make respect program to say which of

success company by AMD. part success elevated -- it is that be So OpRegen are in straightforward that pretty dry and that looking is build -- the here we future will the a to of

it's best also in invest abundantly so pipeline how we one industry, clear we that ever environment programs. biotech of the the irresponsible can't in is been be not However, our this has that for

staging be multiple assets. they i.e., are They And have in can appropriate an clinically to or are far development. staged intentionally along are where adjusted So that financial to how we level with today respect of they preclinically, commitment. reflect

we for to would So our on initiate R&D and done return with decision exciting were early I get approximately previously what there point are high. I to loss to testing $X to quite the spending. our acquisitions investments million example to the And areas And that I the the there shared that some that is think that business preclinical ANPX value best essentially spend relatively our into program hearing stage single-asset and amount that program. believe small of some were was

be program. thinking just all or partnering, from is forward we it's that should data we of discipline to hope a asking and exciting our that the should be while and to use Is about ourselves we're So And move carefully something ROI evaluation critical we platform. always we the will stepwise something at others while, funding? OpRegen the spending way as future sort manage it across want that if wait it with something we look for what grant we

lot Thanks Great. a for that answer.

you, Thank Jason.

go of comes Riley question Securities. ahead. the line from from next Mayank Our B. Please Mamtani

the on [ph] for progress. Madison the guys. congrats taking Hi, call for Mayank. on Thanks and

take? the quick secondly, days it be for And then just sounds you will I'm XX amendment in how long move guys Thanks. as it responsible clinic XQ be submit would actually past, no transferring partners like a OpRegen, process transport Once you long question. your your into you before will on in IND wondering regarding how there? Just longer production that capacity you're to the

the A when are clear a contracting time minimize you side, amount side. a legal of the for questions, the OPCX, open is actually getting between to site. we of to site the lot regrettably to time and respect site Madison. opening the look With the contracting always we through on and Thank the process and

good I about around turning their think are documentation. generally speaking, sponsors

each own animal site its challenges. But own its poses and is

no we delay. to have do as benefit in start having much reason think we would to any I we trials way a by So quickly. that as can these

period until So while but to that we be out of there sites, And can XX-day very open. to be have an everything won't a study to of after going know small ready. clearing able that number fully with are has start frustrating, do we occurred, this parable quickly many to you'll centers will we very be at are others a when IND engage there allow that's expectation an you some but you path the

advance have us, being multi-center blend. us But a to redundancy the parallel possible extent to it's the of different going So done running the hurdles. you're ready work with for a for When and preplan in and ground period. best to path hit answer trial, is you that to be find XX-day

I how the therapy to idea never it a because cell to pharma takes to respect it long a production question, no before. transfer have we've partner, second With done big process

However, we to ability teach manufacturing achieve train abundant cells and reproducibly and and manufacturing the faith production as in everyone work knows, have the consistently on to probably collaborators team our been failures world, their call controlling around the seen laboratories process we our team. and is by difficult extraordinary of success very have and in but have in-house many the skilled the there examples many over manufacturing years

to quickly. differentiation protocol being to those One very a spoke examples create of with ANPX I able

OPCX purity program I of me, how with were misspoke, example of example to be Another meant case. third A previously and OPCX. able in which achieved well scale the OpRegen improve OPCX an that they enormous and -- production, scale excuse I the the would the they would be

paucity different of has the the Genentech So no to three that resources they reason that this quite those manufacturing think programs, capabilities abundant of in Roche have opposite. expect I have the illustrate team. are a I capabilities or And three from capabilities regard. and examples which

a a simple not straightforward you you So into while send somebody, don't can't them mail document. just it and task, it's

to next it we and very You when really to the completed, would pay I going to be am to great our best attention give partner process tell several you need it think unable sitting I with chance really possible repeating will through success. that times. be of them closely the to work but

it. the appreciate I Got color.

you, Thank

Our go line Maxim Okunewitch next the question Michael ahead. from Group. comes Please from of

progress you the congrats Hey, this Brain. question taking quarter. Thank and for on my

Thank you, Michael

ongoing the with which important full just if platform to those that partner, from a as about see program to additional the the to at I'd both I well as think ask for you for us your to VACX analyses as start prime little VACX could the bit analyses off, particular and most whole itself. you of the the be like consider validating kind study UK of data program do a

question. refer to for to to Michael, Thank Hogge the will you, Dr. you. I respond

for investigations see way skin So at at keenly administrations. from influx looking occurred biopsies We're of to administration the looking to post look data. six We're ongoing administration their cell at what of site type lymphocytes. first the all tumors biopsies are tumor interested to in infiltrating up the those

that profile if time. So that'll over changes interested be

may or indicative immune looking we're and we're interest these laser in certainly look would to if we of well least interested to antigens be baseline. potential ThX cytokine some We wasn't of at shift have different a a a anti-tumor a that And all was there see show ThX Additionally, the that there that panels. profile looking response effect at as at.

Cancer report from analyzed those we are and data Research wait So UK. to being

additional one-and-done more therapies once as would out the pretty making ANPX? way I any you Do it there have see for gets some look into do then for attention. -- And therapy clinic? the towards significant with you go indications you in having additional specific that. disease for to in you going might have this you specifically the And then Thank just Yes. development color about paving to on right. space, ask gene like attractive auditory the All

by use difficult collect refinement clinic. driven approach the patient data I indication Michael. initially of of aware aging there to be impairment, evolving new best be intervention. that of such a and which types we're of the are about And more this population answer. into Thanks, see hearing quite a and to processes. definitive with of and how have physical, many for two-part be we The some them them the some It's incredibly us definitive, then reflecting the intended of the we pre-clinically degenerative some will chemicals, them

in of to to establish economics seeing hearing refine some some those through to what approaches let's have to is the think, beginning clinical The if loss, going look come the have I for going to patient it, that we're some for and of our other approaches going notable refined and aspect the like is use program, right is endpoints get need what credit are of call a are because what to existence addressable it's earlier some beneficial program going because, to program, to a a sort ultimately, that's of preclinical which market, to today very is questions exercise, we're an of need about sort success which valuation population.

area we and that to trade-off of commercial we with market threats, competitive point can we're it's for into certainty a after. to that and So going go incredible or new the patients an have dearth don't established a what with while other paucity exactly we know is exciting mature say

forays of particular, I to as hearing crowded available of replacement repair earlier, sort a options able lot is that gene some gene than in but I'm many So forced entire genome through the space there's one other into be information this is of loss others, wonderfully leave loss And seeing, new rather the therapy. the that of genetic an specific genome of this to a can transplant area going into of the going be area, to address in in if ourselves approach or is a through the in to think the new therapy that described to even of that because compared it following deficiency cell. we to replacing a learn hearing from and kinds define delighted early mature I for space light partly some we are in

Thank you. insight. I your appreciate

Thank question. the you for

Allen from Baird. line from Our ahead. the Please Jack next comes go of question

for follow-up and again taking the the questions here. Thanks Great.

are Roche's question just of of peer mentioned I thought one my Phase You drive about a a asking have you to the my response lot execution know in was Xa OpRegen enrollment of a you study. to patients of of Phase X/X the experience historical I in guess, enroll sites you it utilized collaborator. to sites study? as could being speak your any by the ability those with relates context the to that that as question

things likes incredibly courageous and therapy. early there open first in was this I One that part were into because these very enrolled of study that some patients time part because to slowly, and to few sites highlight were very the very receive in ago this the the forays

had end additional taking control the sites all of within I were By patients of period of the had weeks. to this at enrollment. and We think very enroll, opened maybe study, able eight we were or Lineage a six team the four crowded last

at site variability reflecting but individual that of at occurs pace level. which the the study just enrollment, of is not level also So tremendous

able this as to to at kind, an I different think you're In are it's that think -- I go from gain favor. well the they of refer pharma of same I accessible this so data is time, to a believe and of sets would much study. about like prospective that has patient some and optimization or to to its talking So information possible a Roche the that number there factors can the the the XX credibility the our program that rather minimize first surgeon but in than particular, is being the study, possible, because extent today, variables and be between conversation and center highly as

in and horsepower done obviously, in doing with that start there used expand time. a than have quite what previously. in us had sentiment to that I. with for Phase this we some the were run I just more so, I expect out sites by think not will the they Roche it's elected it's trial is that. general to is finding although, being available information that specific the of lineage, delighted had and hands have was over success I there we don't that about surprising more we our Genentech that that encouraged I'm that And But experience

great color. follow-up. taking for again you Great. Thank the That's

Jack. you. that, appreciate I Thank

the Our H.C. line question from go Pantginis of ahead. from Joe Please comes Wainwright. next

guys. Hey, follow-up Thanks as the well. taking for

looking X Akouos takeouts the at you're and the Decibel. Can referred sort a little describe, want to when a looking you what's So correlate of, the and you're of program, bit now that I at more here. dive to sort I, in you that And AMP wanted planned? little with models right to of,

on focused were AAVs Now They which necessarily their do. to. in they are you alluded don't using gene very of as need specific targeting you very therapy, and mutations,

So what look animal they of were able you. a to models kind broader hearing to like models, address Thanks. in Otoferlin would be looking models to What concept? have at do or you particular loss

the even update and And on of plan focuses It's emphasis our is a question. this durability question. on cells Joe. We Thank the at more because at year. cells. is ANPX point, our an delivery time great understand later I this our that you, suitable the do of question the probably our primarily to provide and

aren't where functional, As everyone cells not going that's to present, we knows, if need they're your to be and go.

we clinically relevant of various to them ensuring this where which progress cells amount the are we done quite where at are are which forms in that conventional our and functional to comparisons that the really stepwise can on models. space, So get after want are in means go rodent we're using models have ensuring a that not present designing the level here, still that of they or own we are time the tests studies been main just We focused space. and

defects a will you're a can that. DNA to gene to are having that needing the other outcome to so a extent easier we therapy do folks think therapy But update, doing thinking genetic that across I parallels able that it repair companies have from fix have gene be do specific begin they models then defect more clinical to we're can to the about and and show what draw when to think But what some doing. I fulsome that and be of

a by into need hearing. responsible forced the be to characterize we single use what being would such gene difficulty of aren't I forms deafness not we we can effective would as approach trapped of cruder the segment because or for Our that have that narrow of absence do

that's to appreciate D sense. I on That Obviously, the durability. words, your And experiments makes of great going just I'm to just one delivery. that. the look and you at need focus

techniques. standardized very you're essentially you is a relatively much dealing limited AAV volume surgical at looking cells been what's So smaller environment, than and are with

know really something to this we'd unique forward-looking, tally? to too that pretty is is consider, go I even that down is or or more to cells it have there Now early

where that, because, one vectors viral We appear than eye. an larger cells know You're that's and And viral can we contralateral other are chiasm setting excellent asking that interesting across question think the extremely the of place the the of eye. optic much untreated in travel course, vectors. is on

So arms control in makes that space a bit challenging. that

hand. a ear, to capable it steady delivery is the needles and -tiny what extraordinary with learn With tiny respect to to is

eye with be, everywhere So have as the some we deliver, get because it's cord you the spinal where to needs as delivery do challenges to if the the challenges work. correctly it doesn't to not note, we to to have stuff in or the or do going

in year. So is some I perform these findings think this I our is, helpful of at generally update speaking, methods we what we will interim. of preclinical not invent share to that our needed think that particular, I But later in do have and If -- we'll that in at anything studies. can have order to that say not answer the we least new some

can't Thanks to does, hear I certainly wait Brian. lot. about it a No, it.

Joe. you, Thank

would the like Brian now over closing remarks. to I call. call analyst for to Culley, turn today's concludes That

work you, great continue hard this doing. great exciting to would successful. Thank to afternoon. just like have you. thank And in everyone. make to that It's company have interest such and exciting and interesting all a will the say things And I we're to we

Thank gentlemen, you you. does Ladies and conclude this call. for today's Thank your participation.

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