Earnings call transcript Q1 2023

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Operator

Good morning, and welcome to the Precision First Quarter 2023 Financial Results and Business Update Call. [Operator Instructions] Please note this event is being recorded.

I would now like to turn the conference over to Steve Harasym, Vice President of Investor Relations. Please go ahead.

Steve Harasym

Thank you, Ryan, and thank you to everyone joining us this morning. Dr. are today me With Helen Sabzevari, Harry as as of and our CFO. CEO Thomasian Precigen; well President Helen an our across quarter our which will have will XXXX pipeline we provide Harry programs update financial on results. and our highlight review upcoming after progress milestones, first the made

Following remarks, open we the to Q&A. our prepared will call

we like briefly to Before review our begin, I'd forward-looking statements.

statements the risks by statements. SEC and will and as recent Investors cause in or are from our those uncertainties. uncertainties harbor our factors forward-looking in During safe present are could statements. read cautioned expectations current filings statement for to forward-looking indicated today's as are make contained call, actual risks on risk forward-looking various outcomes and of Please a most we the more the that well to subject based discussion complete that results differ

would I call to Dr. to Helen? Sabzevari. the now like over turn

Helen Sabzevari

thanks and Steve, to joining you for Thanks, today. of all us

lead want therapies and that an potential are our innovative update to Before clinical the transform patient approach to the foundation programs, that to clinical on have I principles X outcomes. emphasize of provide our care I the

need focus are that indications we high for have approaches First, new which therapeutic urgently unmet on needed. and

designed also new enable and are but pricing. of gene cell therapies recent novel Second, but to the health clinical and limitation we systems is benefit to modalities, prices. that breakthrough committed only and also of disruptive cost-effective can manufacture in more on we create they therapies, spaces those and only not by payers. strive significant not impose delivery modes many develop differentiated, pricing that substantial burden access key to a provide, to especially are financial barriers innovating Thus, by the treatment therapy the potentially

that revenues generating we us address to possible are us quickly build have maintaining to sustain our as long-term our pursue potentially ability approach cost-effective patient finally, will shareholders to we fiscal a that programs we unmet more R&D as and and our committed commercialization. past a expand and to and moves product And This Third, rapid needs advance executing value believe allows discipline. rapidly for pipeline. model

we later XXXX, into runway review which allow in we would will capital progress clinical the continue us demonstrating call, Harry development currently anticipate have As late across our portfolio. important to

highlights I'd with of capture our year. in and we first Now, have what to provide quarter of like portfolio the accomplished this you

platform This platform. platform with that I'm is familiar be first inverse audience sure ad are this our The is platform. gorilla I discussing unique And a and of our will adenoviruses. many differentiated uses that

that first and around epitopes introduce We meaning you be have many vectors all, up these a unique to can allows; deliver. genes these you XX gorilla a full kb large IP can vectors payload of basically, many And capacity, this. put combined, that can

enhancing Secondly, and and is such other of platforms result as concerned, that, AdX a redosing very complete as system. lentiviruses as importantly far or ability with of as the the is retroviruses immune differentiation

this all responses, to The therapeutic we directly platform, our within very is Sesplatform if the and and while antibodies keeping this from and of a what giving makes recommend your By drugs, enhance is T unique done drug X this brought the this. website can cell others. at neutralizing which seen at have highly have please you from Bay, go you system by I the utilization products. of immune are platform differentiated you educate take video own way not these look platform, actually works

The first I addressing one will PRGM that our be XXXX. is

to basically the local presented, in PRG of surgeries disease is X over of of patients And our the currently which thing rare cause adenovirus population PRG course also for a data continuously a PR that in epitope no system done There their vaccination the lifetime. can disease. patient. the vaccination a with refer and this that Phase these patient Trakya. for XXXX therapies have complete courts of this papilloma expansion as X papilloma and of patients the that this gorilla in a These all, threatening and this contains the and with XXXX, surgery a of works that data. only data we very is of immune January favorable showed The In they recurrent we regeneration XXXX. acquired this in XX, for way population, first year, that of patient in we which repeated is respiratory the X it's be safety papilloma to the generation HPV is their hundreds is in some

not shown R&D have of had And XX seen after our that These up whereas they T corresponds showed more the in very X what of safety favorable have not At it January did X of a after was some response population, DLT any that conjunction, enhanced X, require any to to of and symptoms the very responses when mechanism same receive you patient cells action in them or how grade than in a We in presentation follow-up. data But flu-like exactly patients to the Day rate. have the and complete year. kind data surgery months nothing in profile. XX severe similar at the token, follow-up, X token, we on this the same surgeries XX% vaccinations, months per subcutaneously. we

So we about are excited very this.

at the is for to our upcoming are and the fast rare the RRP productive very I'm new the and attention especially communicated, shareholders coming which we approvals the have of FDA, for FDA coming But for results. highlight seen token, that same drugs. given is the regard committed I'd FDA, guidances solutions and the we in have and communications the from months, As diseases, the we like is on to recent the to that are and in these share this months, continuing, in discussions in with are sure

upcoming we XXXX. are looking regard So with very in shareholders we communications in months the our to and PRT in very, excited, are to forward

drug product the PRGN-XXXX. the that currently our AdenoVerse using Another trials in clinical is platform is same

this secondary combination the in communicated of Phase that will others. beginning this. cause of market as is HPV patient cancer such The is what patients. in you AN cervical that -- with on targets population cancer, rate world to the HPV-related XX%. of cancer, cohorts actually huge need for achieved patient -- if line X% at cancer PRGN-XXXX And a The neck is the XX available cervical and year, the inhibitors at in neck, checkpoint I addressing of checkpoint related, best to on cancers full head with on is currently is and data sharing totally look indications all we head response and HPV the which have a we be and HPV-related the major PRGN-XXXX huge and and XX% the XX, inhibitors this

the the cancer, will This stage will So coming be is is that on. which for innovative all both you that understand cervical excited head in up IV are the presented therapies, the with And data and patient a data we about presented. really be population. need neck can cancer we comers, and believe PRGN-XXXX

be presented will now failed And other all only response, they ASCO that the checkpoint and excited one stress, these our investigators efficacy clinical and will will safety And cover sharing be we that the should therapies, that thing but are inhibitors. including data ASCO. at the that the I also patients have dose not the are that preliminary at

actually neck in we And move I head Phase important very therapy all done for have is to these have it II currently in would is arms a care. is you how what we study line. front it to XXXX in is the that And a X into that that. We setting. this PRGN-XXXX adjuvant look for token, of front-line neoadjuvant in new the therapies TRG ongoing, position So encourage of is the exciting. same and therapy move front know our in to standard positioned and At

this. of finished monotherapy have We the on

that combination prior standard basically the and be very, will the especially population followed care they very excited therapy and is this Titorda upcoming up important tell which starting will in their receive I'm you patient our of in products be for to And address with then responses, the will a months. that setting. to And enhancement drug immune will that of

think So this exciting the will but we is -- only be reporting I onset an by the on year the this early the interim data that we stages, at of quite will addresses the disease. it And latest PRGN-XXXX. also addresses of have not that program promised be as end

you give to what So with of our that, done. and like UltraCAR I'd we move to overview have an platform

that believe overnight in patient And T platform is the clinical trials we is car the day platform classical are it's Ultra only next all modify you actually differentiated you of them T autologous the patient can all the actually bad. that overnight. TCRs unique know, the fact other the cars, of from As infuse our and currently a cells you that and the you this truly have We ongoing. cells modify

AML or a These is for left. The in addresses patient the that limited other very, is in that with kill which well IL-XX time membrane-bound is time, will the manufacturing patients even target which gene CDX, PRGN-XXXX, Ultra-CART switch. CAR-Ts is anything these all patient a cell other first as not and not patients. have there our includes And the failed it population this the this truly for one have as enough therapy conventional very therapies population

bay. be only Phase on almost objective of of that but the they you FDA that also arm now the that cost our Phase in disease multiple At with And and also not the and in patients favorable, patients these the as manner, that sites, the the expansion overnight a we Currently, the they it patients. orphan at data we on this against the and the have very has the unmet this time why to opacarcan showed favorable believe their lines patient. And other ASH, period a track of but fast platform the drug is given in preliminary our safety from important? not reported patients that the to The XX% but Because is also all can prior. showed effective expanding are only persist keeping we only we designation responses a can UltraCAR-T only expand it the us the in I safety in failed redose manufacturing, redose not tumors Ultra-CART ability over Ib. of need cost-effective designation

regard platform, In very, in data and XXXX will presenting our therapy. the on is FDA in UltraCar as have we both month arm. our look and cell be Phase intraperitoneal forward to very we recall, is of that. you expansion we PRGN-XXXX, X this and IV trial, -- also field and important we our and to cohort, the which And as The also cancer, gene for And on Ib membrane-band XX it next promised, ovarian sage. targets lymphodepletion includes arms IL-XX directly open to KL us allowed had this

We also only we of show data, are have a in we January these can dosing at in efficacy that these -- will finished and this these persist early be data. patients, excited the The -- expand mechanism but in of as not promised the about action ASCO they all. preliminary can Ultra-CARTs presented because

that on that very, patients we additional efficacy cohort arm that, be the aspect would be based in be is that XXXX. presented that well XXXX. see But and at we in expansion, which months, dosing that we receive safety will And Phase our to phase, IP in and And is expansion moved both very data will start one the exciting. that in on at expansion based the added this you that with very be to will will will presented be it we ASCO, split this important will And ASCO. an have data also IV on the going the and arm reporting upcoming as in Ib will also other a have

the a our be to look go presented So and at poster sure the by please make will you data that take ASCO that investigators.

as that the UltraCAR-T is PRGN-XXXX, on third The our would generation it's like our PRGNXXXX. refer of to cost. to what I base next touch And we

imagine which that systemic now lot mean the And that, in general, with It's conjunction become in perspective, people What especially you're toxicity can has moving evident from of do other has therapies, of checkpoint simple. with given, of already we combination by and that? In the be CAR-Ts. checkpoint and but this next-generation our expressed the on of fill a IL-XX, that are tremendous inhibitor. you also that inhibitor ultracaut a It cost to also caused, interest, expresses a down use mechanism is expresses case, solid Bolon done or both regulates is intrinsic the setup, an our switch quite cat when what membrane-bound you checkpoint classical inhibitor. but is which in not have it design that we tumors, has that only hematological and adding

it makes cost basically of the and checkpoint obviously, it irrelevant So inhibitors use the of that. systemic for

by And umbrella this step goals. this be having year made end patients. that of it -- the as triple-negative And one the as as this patient and quarter. tumors, be the of library hematological Ultra-CARTs will in closer first in as patients We one as you being enrolled for such dosed indications seen will parts this and press put addressing cancer, to we have most interim vision overnight as as this breast trial. ECL speak PRGN us only we it's trial, having with XXXX, we has the of needed that in brought be the data CLL release, our well mentioned, as basically as are for not presented an And important such is of excited, of this was the an as the with a diseases part are we I solid have various of our can have

after rights regaining And finally, our and for PRGN-XXXX like what CDXX to I'd is BCMA. stress the

be this validated solid And very we one, excited and indication. has across roof. of be various for targets now have in shown various token, exciting the very will now patients treatment for our that to effective ability that the for can both At validated redosed. these about car that with these cost offer for ultra same platform, shown hematological this are they combination reasons. two, We we their quite platform the have indications, under in already of this that that are is Number for we And tumors. paradigm the both same having change the believe ultraprator

Precigen CDXX BCMA. at also this we the been address rapidly. teams has I aim year forward to our end and is by Phase And then of moving And will be ready our for

the can platform what CAR-Ts in first that but That's drugs in are we in is only take to between the from products thing So we are And the also not as there. forward path the perspective, important the aware the the we taking are patient, These our we but the a be approved we for being currently drug excited good and is there far these important, class. validity most as the market. and very The are that targets, sometimes of portion classical out market. class, to believe best class. best the of that a have

the And In and part especially also our we regained why programs with token, and we our IL-XX one been for is rights excited a these and molecules of IL-XX CDXX best past And that, this important? combination. with controlled and of same considered is role the decades. immune that moving the rapidly. enhancement of are has the always as in patch rights the for of At The Gorilla regaining BCMA, very responses IL-XX why sewage. for

IL-XX. amount we for very with of However, been highest current always in for the our company issue our who the especially combination biggest clinical very IL-XX, unique for makes with the future. and and are, has now This switch has only the the with portfolio, absolutely we believe, it molecules appropriate control the control data

saying and the And IL-X center. head recent has potent but our neck one and now molecules have the been under that most role roof indications, across the of up the in have same that shown become we I'm specifically of Why data various portfolio. with

months about will the are be upcoming half year. and this that, We we discussing excited the of in and

So to Harry with address to that, I Harry? like report. transfer now would financial to our

Harry Thomasian

appreciate on call. quarterly your Thanks, the of Alan, you all to good I in our participation and morning update.

quarter, you containing notes. updating an a progress footing minutes cost support progress make spend I our make on first on convertible start to the to our few on strengthening financial want continued the continue our to I'll business perspective. During we financial while from a with we've objectives. to update

first at discount an we face $XX.X the value convertible to During quarter, repurchased of million notes additional par. a

convertible remaining was of of As balance March $XX.X of our XX, paid notes the maturity which will on be million, July or year. before X at this

retirement to continue million which has value cash we've will To prior date, of million. We these $XXX.X saved $X restricted to retired balance close utilize to and convertible the million our of original the face maturity, company our of $XXX notes securities.

at we matters, efficiencies goal rightsized our started G&A I as ago, G&A a time, litigation years a we towards of focus approximately reduce through that when settlement or spend. older Precigen have Secondly, well function believe settlement as we to Since progress X.X that set on our costs.

XX% our same spend to that that quarters pleased for We G&A expense believe remaining am year the our announce this period to year. approximates year. decreased I first has in anticipate last first quarter this G&A compared of we the by the what quarter

also in to research increased reported year financial comparison see have information, the in development our You'll our costs prior quarter. and

been interest the of capital to costs, towards drug redirect and able discovery. in our With we reduction mission have our G&A

trend candidates. continue of further this with advancement our to expect We product

to cash Turning our burn.

for the year the was million Our ago current million versus $XX.X net cash operations quarter. used in quarter $XX.X in

of from prior than positively last owned third positive in was of sale reduced more year's offset quarter the Our business quarter previously costs. cash cash G&A by burn TransOva flow interest and its million approximately first our the XXXX. to in a impacted These costs $X

the spend the while XXXX. R&D first still of quarter able addition, In were burn our reducing for to quarter we compared increase current to our

in our equity the cash our This guidance combined on provided support and provided debt. you our early late is runway. of has a with financial XXXX. our solid our retirement with priorities for to your offering summary, discipline, thank of of runway cash program Precigen. public January support into our In previously consistent I

happy you that the queue, questions. questions could would now to from if We'll Ryan, take great. let your in come be be

Operator

Thank you.

We comes will the JMP Our begin question with now Instructions] Butler Securities. [Operator question-and-answer from Jason first session.

Jason Butler

how first for enrolled us PRGN from you're you see present all on details XXXX. we more the on data the should Will of subset? some or Two just one going rationale to ASCO? the Rollon you us for the the And here congrats think secondly, mechanistic Helen, me; color for can maybe PRGNXXXX, give give And Can a at then patients we progress. follow-up? duration tumors? about In in data some on solid on

Helen Sabzevari

Absolutely. and you, regards Thank expansion will also I for the in In the to checkpoint with cohort data there inhibitor a the XXXX, on full -- Jason, Phase questions. PRG for be only presentation be And also the not action action of I'm scientific that and safety, the of the you brought glad the presented on the some point, will of up. that mechanism and mechanism efficacy. to the

think be on very what presentation will I unique. which responses, there objective exciting only is is not

cohorts we be well in cervical failed that as in in show name that majority in patient to XX% up will have presented. this combination we patients, in XX response they is, have As population way, there the But in this by be a rate patient mentioned, neck. the I as the scenario, on that both best case checkpoint inhibitor. population also, head And that and will

of In the patient durability our the really have which investigators I they presenting and on and is trial as in the And have these we addressing inhibitor is then And you that can raised, at because to an a negative the to show patients then what point to on patients. stopped regard of we checkpoint patient number the other and designed, as excitement this part of as the such negative a is There part PRG their that covers. on way population currently, triple same PRGNXXXX, basis. is this an expressed actually I various same responding And BCLL to be triple from our area target the of the in is inhibitors, it think token, because responses, is XXXX the then will exciting solid the that you here well world add will -- responses. when X checkpoint think hematological the hematological the settings tumors. for range need especially CLL,

truly out therapies failed And have for really car As for to no patient. or no any that they know, point there classical knowledge, therapies you CAR-T other really, there are everything. my programs this this patients at

reason they they of microenvironment. And checkpoint cars, they read of the And be are shot. of makes combine number because, of tumor day, reasons it lot to now as for first T of conventional is inhibitors thoughts, the addressed. a will is And inhibition. the addressing the of checkpoint with end of the all one result, at through Therefore, to inhibition know the they They have So for it the cannot these the cells. we TCR, that the tumor off-the-shelf design and part those. issues a pace, unique. T to cell need be of subjected microenvironment the entering all, A needs they only that the are the

an that's issue. So

to And overcome tumor challenges. microenvironment this have secondly, they

the our us, is is that UltraCAR-T. toxicity checkpoint Why So to there and is us no designed inhibitor others. inhibit ultra-vectors or we our important? can Because incorporate within signal directly have no with mechanism just systemic allows we to there that

your any will away importantly, further, but more systemic $XXX,XXX -- add, you added $XXX,XXX So to Ketorda now also has the that to price T. instance, and tag active to that need it's another the price UltraCAR-T stay from for be conventional tag just of own CAR don't you get from toxicity,

that's the happening exciting unique. irrelevant. combination this makes now. very addition And it is same token, what it's a And have platform the we So think as at why very allows of the this that, of that result right is we the

Jason Butler

are details Great. the all Appreciate Thank home. you.

Operator

you. Thank

Our next question comes from Fitzgerald. Jennifer Cantor Kim from

Jennifer Kim

certain since to I'm you you in year. in in is present data anything to here. there this your an questions Maybe I with that look? have I that dosing. I on start mentioned my I tumor into and in you it some trial, think you et that And Could plan more cetera? wondering, want terms question implications you're is what what to detail that on of this And tumor think XXX, comments types versus second of heard flagged what split something of entails few Are there interested on you umbrella go XXXX, solid heme, also interim that? a initial see then pursuing sort the and is, for

Helen Sabzevari

Thanks, Jeff. absolutely. Yes,

for I perspective of So in and regards a to database. completed. The of will the PRGM we be will the of I we bases of XXX, are by At what the how maybe I some is doses we And should we data Currently, this be just we on addressing end said preliminary a some Phase year, maybe sort end of give the full cohorts, the be in in of year, and that a make sort that will will that more clear. view from I. Phase XXXX. have perhaps color expansion the Phase going some a

So that's and PRGN-XXXX because of definitely, far the trial how of to going a we in give data. And we will we of want preliminary. going on some the regard discussing started. be is complete on set data views But just as the more as to is the course,

finishing be year. Phase year. by presented not will We This I all will completely be by this the next

this ASCO. going by now the our dosing. investigators. -- And ASCO, of in right details split the because presented at very In that will the will to And because interesting and we the to the have but embargos, regard that cannot data be is be some PRD we XXX presented this be the

deduce in it what you after very when observing with important the really new you IV to result do open. why on route both Phase of as this a by also also gone and perspective lymphodepletion. also have now is a the the when we And arms. not persistent have the and how was mechanism the that the of to preliminary we the IV that, the lymphodepletion And see in intraperitoneal that but car, we will the and efficacy that, top the expansion way, with of You and out of regard lymphodepletion, X it works so give the see it's points makes unique data. exists a arms give And -- without infusion Ultra from our ad the on how already Ib only and difference, you versus

permission on to As we read ASCO in also of is split done. be FDA know, be ovarian I, see we presented by to can what that going received can else the at But the and exciting will -- that way, be you totality the now patient the data, the is dosing from And those, population, that. data based are actually the these all also to regard Stage cancer.

And split are patient patient of cannot ability the number population, the our that So tumor upcoming because nothing large a ovarian that of cancer, of the we what make these is XX% doing can make in same because enough you the even platform, this of imagine, nothing as doses in can years. that, for the can a an can intraperitoneal intraperitoneally the cavity. with response and rate and has many that you moved needle the of remove UltraCar surgeons that receive dose a and you dose infused a patient is patients, within totality that is

But at you address same to metastasis need that. that body. the address is you the around the So token, need to

discussing looking to will that's are this IV as starting And be and that, we the the very dosing. receive are next in patient this which forward so the excited we the display design, and this dose, intraperitoneal the be would dose, we about. will And few months,

Jennifer Kim

asset. Any question XXXX? remind pursuing of FDA can one you possible and the XXXX outcomes discussions? for strategies on Okay, timing more on great. And Maybe that you're on updates the us the

Helen Sabzevari

Absolutely.

dose clinical should So I has of in we very is reported the want been cohort of release in Phase that of I buy outstanding And done the any now to in exciting. one full this we only XXXX. today which just chance XXXX. And we expansion the to I is XXXX, basically want started the Not on enrollment. the I because I thing really those mention in forgot Phase been XXXX, follow-up II has that of if stress, the data finished but press I April II X have everyone, our started Phase we had January trial what are and PRG in work remind Phase patients, XX-month the

see patients get moved now not teams XX and rapidly only in to you I Phase how can the So our the have II. have the Phase

level has in are dose received XX and we about So Phase the that that. really the a II, X total patients excited

In the are a regards very to FDA, interactions a we productive the in discussion, discussion. continuous with

course, shareholders outside our that has answer. with and by us giving investors to fact and respected FDA the finalization be complete Of communication the of the our and

where safe this. to our we at of discussions. been in months past advanced encouraged discussions especially efficacious drug guidances in and for traction we basically rare by And are regard it's view and needs products a faster the that in and has a exactly especially for in innovative that few the the OTAT Marks treated very productive. with to and what very the Dr. a FDA. be allows more are unmet And It's So the being are changes mentioning new guidances the diseases, are how

as finalization have of be mentioned, we the the soon the FDA. have we as strategy by communicating So we will as

the point the confidentiality at discussion. time FDA have and the to respect lines of of we However, this

So say is please what I tuned. stay

for it's exciting be going year think us. to I an

Jennifer Kim

Helen. you. Thank Thanks, Awesome.

Operator

Burnett question from next Stifel. Ben comes from Our

Carolina Ibanez Ventoso

program. the on Ibanez our all progress, Carolina for Ventoso XXXX peer is A question. this and Burnett. the for thank Hello, you Congratulations follow-up taking on Ben Gen

results few remarks months. additional I in a think said to prepared your you plan you present Alan, in that

If before that you out number you some this update. in then that? get XX patients you you present follow-up of could if that? have can what are see feedback expect data to a results of terms confirm we we And until a wait the of or may time already FDA to clear involved And going in

Helen Sabzevari

Yes. Thanks, Katherine, for the question.

we January in We the patient. a of PRG regards the further Phase very response, XXXX, I responses. of complete shown Phase in safety be to would of the well patient by expansion First cohort all, I data. of solid as presentation as totality actually in as no XX% it, It's the a the have in the and presented there full

that. next the they finished in the of context II follow-up the of when presentation, will of be full basically course, data have the and So Phase

As excited. I are mentioned, we

it's We will the of obviously, patient XX in have XX months enrollment first follow-up -- patient, followed have there complete. II the being the of Phase the be last from a they our patients finished been -- are -- they to and

I of the for of has is talk of you injection our per flu have surgery, have in day of requirement more view with at have or in mentioned, out in more. of the And the patient When uniqueness that we number have required These gone unique. safety and the XX% actually much surgery X like a them been and have which severe investigators most the very almost side and subcu which, they nothing safety after obviously the way, extremely efficacy are data, patients XX% a bit that that of minimum about shown some data, maybe have discussions reaction of but than is a pointed we required population. a we that our not year fever and enrolled which is the than in And patients rash FDA, the patient X, -- happened, for And the population by but patients. just that majority eliminating a surgeries this the is reducing favorable. as shot that. of little view just more that with the is It's of

course, that we months. of to but with ours, So and didn't or We trial for of reduction go end FDA, the them looks are the if have addressing like can have considered endpoint response gone is points, be robust. extremely does XX from course, just for perspective what in that, discussions that. what the requirement the currently there we number which after pivotal no of surgery the is, of complete with we surgery, and made the of -- The

with out surgery also So that a that communicated disease, part a for rare has population And a we no and are of changes of except of by have in is having view important. And them, the the coming that this current These FDA other in been course, discussions options very in they and durability continuous is patient are front is that leadership. the a the also that FDA. rapid view guidance approval.

We soon have are again, FDA. we the we strategy the be with we excited, will And And respect some the that that and approved, are discussions. the confidentiality, discussions need communicating to confidentiality the as continuing we as have of to as course, outside. mentioned, we place and I

Carolina Ibanez Ventoso

If related to Yes, another I understood. program. ask this may helpful. follow-up Very question

need this of for you results periodic, in annual the So example, vaccine? is booster so of a what with that all accrued the light expectation far, for the an have

Helen Sabzevari

Yes.

completely So, have currently, the pediatric received. the be trials the future that's which that not on follow way will excellent Definitely, our for has be there part surgery, this they they end file we and addressing an that patients and the to also on patient is be and of be strategy will option that because all will the will And boosting we patients of vaccination, population, the this reduce that a population the question. course, didn't safety with in have been can Currently, for market. as commercialization be and another address of that population course, the of address is view these it in that will imagined will towards patient which requirement part PRGN-XXXX, that patient the trial, the also platform that a this for path definitely. that's be

works. those are sure, the within for So

Carolina Ibanez Ventoso

Okay, excellent.

Operator

Thank you.

from comes from Arthur the question Wainwright. He of H.C. line next Our

Arthur He

the XXX two One the you And Harry, had down or dosing of Arthur. the have in how this XXX, need. is I remind for repeating on can is a part us I the follow-up Could physician the terms dosing. the well. as that be repeating questions. by patient judgment

Helen Sabzevari

Arthur. Thanks, Sure.

repeat First population why that? with patient And in the population live. few of is a discretion the requirement. we the currently think they mixed is getting physician. dealing is that we dosing, definitely different to the XXXX, phase regards the for unfortunately, at expansion this So are And a are months, to to patient of have I all, with regard in

have to had hospice patients of We this they out that came the treatment. have receive

how the imagine sick been. have So patients you can

need say, and oncologists -- because that and the extent stability disease the of aggressive So not month in moment might the at a a they are and have that, of every need based might make that their this on judge can the call or the that having clinicians the disease, the X we or more a general, months a instead faster they regimented upfront. of patient well, best much

or why might disease be hand, win their there and not is is that other immediately, then can the require patient the signs they signs and early see enter they clinicians they might patients on stable the Then this of accordingly. if progression,

So And thing is thing. what Ib, required. same that's again, understand disease I'm why investigational and disease need in goes PRGN-XXXX currently, amount this design the the Phase stress the is course of which it's with various the going instance, the one for because, -- an patients the and of to for to also level of

the have eventually drug Of drug, get the the disease X. these are And and move stage of also Stage cancer the are all a PRGN-XXXX don't safety in perspective this goal ovarian we allow going the our with a bring of reality, X, to it same front where of the able that thing. we is all because from stop course, to start to the patients lines to to be will But we to therapeutic is for investigational Stage a earlier. we in to in of -- much We in need IV. course,

have see X, will have will therapies. of they be that presented -- it You and said line as patients have X at ASCO, we you

you that patient of can with done way. that mind, might are have the than of imagine design have therefore, failed different is requirement therapy. that this lines patients And X in a those we So what it

can Phase is to a to of right for down the stage As what get the from the number the of we different we disease the can those. Ib, now, and we But design is, course stages then important according narrow have basically then can read one, disease, we dosing. various data or according further

can that in we without that. and will think platform only the PRGN-XXXX I in -- patients. costs for the do expand that data directly are the in show And ASCO these We cells tremendous can

Arthur He

Sure. Yes, a that follow-up just on part.

one for used dosing? to the So production you how used of on many dosing, for be from for the repeating get doses batch the product average, can repeat

Helen Sabzevari

Yes.

the have. is can a of And as, we I originally more material I we be you tell well think can get, a part you produce than process, can we then for used this obviously, manufacturing from of number our course, can number again. this is that needed later of freeze on, that -- as but that as we to always can doses

So to currently, read been the we able material, have basically, with original those.

Arthur He

us BCMA strategy on Okay. X what's rights And broad my target. for you and give question Could of CDXX a the is the last picture targets? to your regaining those

Helen Sabzevari

Yes, absolutely.

we they What is farmers do Novartis, to Kite, -- know works. strategy our that get this, at for this you it we this patient shown is we a world. that, use been are even price do the access a the works. have beginning this? it's know The has this. everybody that you can struggle similarly, biggest of for the hand can platform manufacture -- the field few everyone not see to from really in a So that. cost. And the CDXX seen a patients They and with but struggle have stack how to I the only afford order BCMA has mean issue --

to ask thing for scale CDXX our platform, us it important. platform, in lot first people show question all, was regard put A first of was So our the to of very targets we with to do. patients. the clinic, platform that and tumors the solid make multiple now does hematological, ask what it in sure it's sure that across safe make many And

have this. shown We

shown the capability. So its -- platform is has this

one else have exactly no again, -- And way, to not I able that should changed knowledge, done. platform by when been we has Sleeping platform to said platform, to to originally And have what we and modify Beauty what we commercially fix bring the patient. the nonviral this a have my viable, overnight a only we scalable be, it that's

and that application did we is BCMA and to what these are platform we change of across because Dronsitive now. important And indication -- plus paradigm the can for why we CDXX doing that. to do assets AML, these we it the validity can ovarian with of So know now the we bring us was our now after and regain targets,

a the also we have do you of drug and first there in scaled better. I the believe and we we think very to and can the to as even And the about how do the on after up And best progress. availability seen this much. though, Congrats just then commercially class we are being Thank class products this we about it's there, out are yes, the and you has can our market. but showing or viable. said, platform ability moving And costs, in And rapidly now. the not affect It's that's first can you market. be why it very

Operator

concludes now to for gentlemen, remarks. closing Sabzevari Thank back you. session. the Dr. Ladies like conference time, and our this question-and-answer this I would turn to At

Helen Sabzevari

Thank you.

indications really Precigen, all and to is are programs making in exciting trust of We've on once our ongoing while need, to we their point, whose to the in which shots advancing programs. that strategic I on multiple time discussed honored faith very us and support Thus, rare a thank aligned Each and As is demonstrated patients the and progress business goal diverse stand outlined provides unmet shareholders also acknowledge clinical our them today at strategy clinical and our clinical next putting principles are objectives, it multiple focus our significant is discipline for a again to with organized to to Precigen would of in GOL objectives. call. I'm the like a our for clinical oncology start and pipeline X everyone their I the to this our meet mentioned, our this and sincerely who of At financial meet I foundational diseases. progress. essential at dedication

toward economics therapy. can realizing you, safe vision the look make with updating to effective that we I pricing for in Thank you our disruptive progress and of patients of again. improve outcomes months the forward as cancer and ahead therapies transformative developing

Operator

Thank now The Thank you you And has may for conference lines. you. disconnect participation. concluded. your your now Precision of

Precigen (PGEN) 10 May 232023 Q1 Earnings call transcript