Earnings call transcript Q2 2023

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Operator

Good morning and welcome to the Precigen Second Quarter and First Half 2023 Financial Results and Business Update Call. Please note this event is being recorded.

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

Steve Harasym

Thank you, operator, and thank you for joining us today. With me are Dr. CEO and and CFO. Thomasian, President Sabzevari, of Harry Precigen; our Helen will releases portfolio. today's details an Helen on our and provide update on After our XXXX which review and Harry half first second financial quarter results. will

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

me Before forward-looking statement. review we briefly our begin, let

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

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

Helen Sabzevari

and significant to us positive first in we for major the Precigen. the which rare you developments, RRP; our while setting announced runway for Steve, regulatory to efforts secondly will lead extend cash for discuss is is very development provide focus you, topics to progress continue PRGN-XXXX this half the like accelerate two we today. of of thanks you and of to to exciting portfolio One, our disease the joining prioritization a all in with that And key day advancement year. and Today an programs in the this I program PRGN-XXXX today. commercialization, XXXX. other made our Thank of we orphan have morning towards I'd our

go to slide With X. that number let's in mind,

surgeries path need is the are both RRP approved major economically. align for FDA patients, physically in active the patients. But recurring health-wise, options high We burden and that on unmet you discussions in have know given as a drugs treatment is regulatory rapid PRGN-XXXX the remains these to for only no there with been

time, Phase the serve to includes has X/X single-arm which support ongoing be control to will X Phase the BLA marker confirmed We additional pivotal approval. BLA submission agreement the from X/X with response cell on that endpoints during has accelerated there ongoing same the will are months been patients with announce pleased support the study responses, the by And which and study following for support the randomized surrogate surgical accelerated as is is to Phase the an already approval. that of the And Phase study intervention have we to the X. FDA no required in percentage submission, an treatment. FDA the the study the for rate, complete no XX way both immunological specific HPV which T implemented At required

and inclusion dosing have FDA also that's the not initiated, the submission and very important we FDA non-complete to has and the reached single the responders. to token, are label are expand a prior potentially for thankful Precigen encouraged the confirmatory completed with they that To the the we for excited needs to study add but At that. an be exploratory evaluate of arm and repeat the the study of BLA. to confirmatory very on about us to same agreement very the even

us. accelerated that you can approval of mean And what pivotal Phase ability serve ongoing licensure. licensure and the to does Phase much a required path go now will are to can Xs our developmental I here The especially, the for we faster, the for as not through significantly X/X for for randomized the time patients can imagine reduce with because that the move as

We contract to substance to Simply maintain doing a in-house internal gene reduced are allows in-house. we commercial this reliance XXXX, expertise to we time leverage and due therapy manufacturing development that? further on reduced produce lines drug the expedite manufacturing Why are the and manufacturers. To our of for us Precigen's facility in launch. control PRGN cost we've of preparing

the at completed. is the the you is we look Phase what of recognize portion we X/X and of the single-arm a data been on has in and Phase If and ongoing as X happened dosing moment have the the seen -- study has this completed have status the current enrollment X take reported study Phase to also

follow-up have presented they follow-up quarter collection the Phase of to a by pleased treated Phase completion surgery-free means complete the X were data months. still we has second X responses XX% that response. And remain Phase needed data they responders with they a months X all of shown the today, complete And of at XXXX. dose level our in is follow-up anticipated surgery X The patients January no the and patients that of the report and are that are XX XX minimum in ongoing. further that we the from

for very the and received promise absence highest to in who patients priority procedures harmful of in possible lifetime Getting RRP the are burdensome patients need and patients about numerous be system. who healthcare the therapy the their that is this as PRGN-XXXX to can We quickly overall pleased surgical of to our obviously. the therapeutic relieve very excited financially as

tremendous years a to – the to discovery pivotal phase trial collaborators to a at pandemic on as in accelerated path like investigators the recognition I'd of including acknowledge from three our the move this about a for years. approval Precigen effort and and PRGN-XXXX an an to point, team

market us. rest. platform number mind, the that to telling at from XXXX slide differentiated if is platform. PRGN And and what And is what seen highlight I look in With we the this about molecule to been what listened this That differentiates like the have would the we KOLs five, unique and and what we have and our have research. KOL the adverse

mechanism stands generate XXXX a of see this cell PRGN X as slide, promising that this can action RRP. what mechanism very of it's a physicians this of about goes molecule is specifically describe patients problem in the And been particularly in papillomas their infection -- impressed to responses viral As the HPV recurrence has HPV thing therapy very are cause one T action and that the in cords dangerous on that really in the lungs. The site with the root important targets of and and and you CAR, the it that XX is out which the seen promising. the this allows which because trachea to very, is vocal is of is root regions this they even

a is there favorable very Secondly, data. safety

will shown Grade you of the And some mentioned Grade and it's as it Phase And pediatrics for see tremendously. there I. flu-like important vaccination. obviously and is have can and We X, an And the was data favorable safety patients clearly is this that the is in they this be extremely some the physicians the are and appreciate X patients especially factor. from the future that safety of

surgeries. the the number of reduction finally, and -- in So,

I think we heard that patients fundamental even less have them. one continuously from reduction in it's our to surgery,

that And require per months having by able do have they surgery. complete they to now ongoing, severe surgeries and any the population, than And not XX and being which that. the responders patient most more require over three we been year in accomplish way

and exciting quite this happy the So are we for patients. is really

What subcutaneously to attractive a platform that been mean? is patient. with administration. finally this the a of route given very that does These And have vaccines

they go receive had and they their office basically subcu flu now differentiation. patients You to can that injection. surgery, the similar continuously the go imagine to under injection quite physician to a And accomplishment this can very is a now and an

is at the we look with are in this that scenario to the of patient. describing top on slide regard you if see mind, what in So, the six we and that number slide

normal You normal are looking basically vocal individual. -- at growth of the cord a

at the these side, patients remove tumors. RRP patient on are dependent you benign the And are a And suffers surgery-only what these continuously looking then right-hand on to from.

to just Just this a imagine to this to Can have continuously for that monthly to them a breathe. you able of basis child having be takes do kind be able surgery. talk to you on or

is no addressing to accelerated patients be go to I'm need therapeutics and the decision in allowing that for which RRP, can innovative for of are that approval, us studies and the also need. there importance the approved recognizing for of Obviously, of the FDA the that general this FDA the thankful the

can during does to surgery of I the RRP comorbidity, can Due a lifetime. we As of is surgeries, this of care of including and surgeries, HPV spread functions. disease. underlying mentioned repeated result nature standard the affect of root as the worsen this their increase condition disease, in And before, the virus not local current undergo can said, chronic RRP have hundreds the of it and as indication can the significant this loss of these of patients repeated

this this numbers in the of a of you significant and in and slide, US, of of of as we -- part the and as market disease we quality that know see these at can of these and the doing that exact US. of juvenile. US, economic burden And number and RRP part XX,XXX there larger ex projected is approximate don't are life of the for on the studies really the least ex X,XXX upwards -- are are is a adult US there cases there And lifetime much population will There patients. the are and juvenile research be throughout

believe the believe in towards company this, near-term markets becoming So success challenging that on considering estate this at doing we now be Precigen best can environment. By We the accelerate to position that commercialization. we with to path should current the XXXX potential a focused laser expediting this we commercial for time. capital and

of a for we the and costs taking respect the CRO and budget Harry now some external past X, estimates. number but us savings, the realign we to just extending to to further and with on especially pipeline Slide current expand various the are beyond are On get are cost measures mention programs our what our over only PRG focus. realize that important we we to will allows It's actions are accelerate by readouts to years we the SG&A to saving path the cash highlighting not compared XXXX resources spending that and very original other substantial year. the taking specifically to damaging the have, needs. without runway, also to the in But which

some through actions. go let's So these of

of reducing in the reducing clinical be will and translational our And number highlight same that of are that. We of definitely, programs sites the do Harry them. to we will for -- go will and so involved through focus continue our all, reducing redirecting team outside as various CMC research the first are I clinical At the to activities. the cost CROs token, we have on and cost been SG&A R&D

work required in currently and no of We we do force. are reduction translational to which teams, order What for is support speak have there in and translational First as path to address a in our productive CMC cross-trained us? this highly focus involved R&D does PRGN-XXXX clinical the approval. to shifting all,

hold to very, very for and that Secondly, that reduction. time will stress to this part. us the very the any, this BLA. save again, trying in I our is to talent we Furthermore, without allows And submission of time the head we agile have adjust lines on count important the money for

priority In high us. a regard our to PRGN-XXXX UltraCAR-T this remains program for

have As patients we received front you that from response we fast in by and objective at they therapy shown a ASH no rate have track designation have positive of AML almost them, data a FDA. know other in XX%

updates Moffitt very productive plan important two view, We Phase maintain a to the Mayo Xb and is for for quarterly of and part be With upcoming program. calls. the now. will There Phase in XXXX sites study extremely this We and of no in sell plan XXXX. that sites the in ongoing interim our we in new active I further data provide remaining to present initiation

clarity expansion planned We in also give have a to on additional XXXX. site

at our PRGN-XXXX site enrollment this Phase cost for to Hutch very of major important program costs part us. as patients that's which under NCI well unique. the our to of and Fred our regard to the the a or without saving with continue very, measures, In CRO activate to we clinical similarly, plan study second we continue very program, CRADA as And is for Xb as advancement

which to is regard Moffitt, obviously continues at program and is PRGN-XXXX, that an to move. initiated In investigator ongoing Phase X

cancer, way the in worse by as what platform Now is platform to a cervical same PRGN-XXXX, mentioned regard in PRGN-XXXX. especially the for on adding we which

we regard excited XXXX We that for in in to the cost sites. first other the NCI leverage is we reduce year and study giving plan X the for the to the announce are to clinical this to early in will activate CRADA our be side and update Phase

with runway discussions in which XXXX. been can have we our non-dilutive funding number important, a from very of and also And further for opportunities even parties extend

I all, is convertible us the that Harry begun, over our important. trends first off divesting to that notes. will has divested Exemplar as and and that completely have Ad speak the process of we of We allowed pay to know

We and very quarters. with program discussion and TXD are for our regard upcoming to of update also in exciting parties AGXXX we an are our discussion planning the a in to give in number investors

there these will believe and addressing along runway we runway cash have all much that to UltraCAR-T that we for up Furthermore, of programs currently we partnerships And funding we that to funding are discussions and ongoing extend are further. our that non-diluted can means that. of on cash have opportunities this the with the non-dilutive be XXXX

the the and Harry? to discuss financial call So, I'm CFO, with to that exciting updates turn to now strategy. Harry over our our update, going

Harry Thomasian

thank for said to a X day on Precigen, the the the to the information momentous also, those toward company. participating is the cash call. of going And call transition announced This to stage our provide commercial with for on Helen. to focus from as the on slide you, PRGN-XXXX, regulatory you positioned speak a I'm to runway notes Thank we've Helen sheet those today. us earlier, balance combined path successfully has just

going million cash our As us this filed statements XX-Q, in our will in which all costs The retirement year interest with see now was the in these earlier financial of SEC you forward. retired notes. convertible morning, will notes our of we $X save per included

able cash through efficient the in of our early save we addition, $X.X a portion million months. past were of convertible significant retirement to the notes, approximately In over XX

are months I SG&A -- of Precigen a of or have to in Turning decreased with on now that year-to-date we costs we've to been $X.X to the SG&A laser-focused last compared since I company pleased XXXX, I'm rightsizing October SG&A. a our And discussion six the for our million around Since on basis, started today. announce XXXX, first XX%. costs

reductions, period A Just XXXX, costs due to positive same last now million year, quarter these of trend first over looking were head the at the portion second the being savings XX%, to are of showing SG&A decreased $X.X a compared realized. or past count which have quarter.

forward-looking a elimination reprioritization of as the quarter of notes finished runway we This investments, into cash, and XXXX well and guidance Taking as a data Helen amount to methods. are for laid a with us cash account cash substantial million runway. X cash has We focus pivotal $XX.X long-term basis Phase in for our XXXX. previously into of pipeline, providing beyond obtain providing runway the on readout Helen equivalents short has the additional and our shareholders, time non-dilutive us gives convertible as it our the via with cash XXXX extended And mentioned. important runway on strong PRGN of provides and funding expenses, out, our continued reducing SG&A now is

I operator Q&A. the will Pete? now turn the for call over to

Operator

session. the Instruction] question will And first you. with this Thank begin we Yes. Securities. [Operator Butler Jason question-and-answer comes time, the from JMP At

Jason Butler

on XXXX. for Thanks the taking question. Congrats Hi. progress. couple the on PRGN A

look population discussion can baseline Thank Just to of remind was there what then Phase complete approval? you X? need you. us the with FDA I to support and a portion the the show patient rate benefit about like follow-up. And any X a Phase you And portion in would in response X Phase the have then just accelerated magnitude characteristics versus

Helen Sabzevari

Sure. Thank Jason. you,

follow-up XX of Phase responses. being discussions of So design responders And as FDA pivotal approval. accelerated I endpoints, with in of agreed with a the And our we the X, a that as mentioned have regard Phase happy as considered current had months. the a in a regard complete for far combination we are complete X has obviously, for data

exact of of X of X in of and Phase same are the are minimum we is And population, same with thankful the patients the that FDA above. same Phase three is basically that Phase our surgery the that very, patient grateful as both characteristics. the leadership X X fact and our One recognition which enrolled to the design things have and very

the same confirm results And has dose level is X, two FDA have of part the this that Phase of the from our the is also endpoint. Phase we the can which We that X combine reason two all level dose and together.

are possibility obviously, what to, have than dose that Also, part also not exciting necessarily to one also per the on surgery part less and one discussions very that additional have and is label as three the little the FDA, additional of be all the in it we year with can dosing. of had patients the confirmatory of for first that surgeries, repeat can by going as even they expand we have

label T-cell thing data have XX% we our which immunological had XX% think, And the address to encouraged in partial of January, reduced responders the in that One mechanism repeat value our complete XX% the FDA are and in the added of enhancement by product. of showed of those the expansion overall against we clearly the the patient and for And number this and it's very surgeries. definitely the have HPV we presentation action that, the has population. another we that. rate of future we I here for response of responses, this of our patients recognizes excellent thankful actually arm dosing, patient us, drug of can the

what points. and we have the as Phase I for the So, I the again, points the by and with mentioned, have and have Phase and confirmed discussion way same yet FDA X we will end the X are mention end had yes, and -- we the agreement

Jason Butler

terms the of, how responses complete frame? second of And your think or wait some seeing timing in were time then about it dose to at give repeat as given the dose. a Would that long first six- the months, you Helen. how we after within you as XX Thanks, you dosing XX-week could actually should Great. in earlier, least

Helen Sabzevari

for of our discussing question. on If that are the the something complete this the is, ones here that Definitely, finishing is currently later two imagine the then obviously, obviously, that, finished, that are aspects. way to complete patient will you if surgery not design vaccination course requires, months surgery. -- the point, treatment. the you so is by with responder they can we a investigators number of is for are the a And it Excellent they can And responders, with nonresponder. treatment as or after considered we partial not depending and Yes. at the imagine this once or can is a which might we this the patients that something responder can course, this for it's various be

of And is to be different us in is then going will FDA, number because also investigators. us look of designation, have of a a seek This and this FDA design with to it. population. And as and rapid part it obviously, breakthrough the we allows our fashion in patient through extremely number also important our further very the to would the be can we valuable and all at which continuous we guidance a discussions with back things dialogue, those,

that. we forward So are looking to

positive FDA optional sees the an it's this and and for This -- repeat encourages encouraging go not stress even that of would I that part is But results us extended the confirmatory. to of is for then the actually want again, us, dosing. like this to us to it's

Jason Butler

again. congrats, and you Thank

Helen Sabzevari

you. Thank

Operator

Cantor And Kim from next with you. Jennifer the question Thank comes Fitzgerald.

Jennifer Kim

for Thanks my… morning. good Hi, taking

Helen Sabzevari

Jennifer. Hi,

Jennifer Kim

have way the in time to there's is of second progress conjunction, BLA start think arms the especially XXXX. submission. a And And to and but a is just about Hi on your submit after. required quarter, positive should said the confirmatory in more a or I good between want few would Thanks. you data this with that then we phase submission, starting Phase if with congrats line positive you the and quarter what BLA there submission, that lot for or study thinking off XXXX, I Maybe on II the currently? know aren't something point the on exploratory

Helen Sabzevari

Yes. ducks on -- our Obviously, we row of the towards a moving are in laser all and submission. the getting BLA focused first

is why, the have assort you it's The Phase it's single And an and we mentioned clearly, data comes we As randomized. in, label, as part. that's one open we X/X not know, can of the exciting have data and preparation. the and their arm the

breakthrough a our through and of plan designation And a part our BLA. rolling have is strategy. ask also this move to We for

further rapid. So for

follow-up And second last mentioned, as be -- done by of II the the will quarter Phase we is XXXX. our finally,

confirmatory we move of So again, and intention confirmatory are and the and of BLA similar can very we we has trial we the have agreement have all already to single-arm And as trial, fast is regard the part of submission be, to to for our be that initiated, clearly prepared done. a as process to what in the trial, that. be going to just our in the

much imagine, discussion needs to not really that what As you there the done. can be design this of or around is

far for as is, are put submit commercial as the patients forward the to currently soon this extension something But entry for design. and or the path for and confirmatory how of because the will and patients no done. arms looking inclusion soon of options, repeat BLA as it's in these the we As that we as are the the see lower of the the we of is priority the dosing, first us disease initiate as know to discussing that we be possible every with Clearly, the this submit to as the can label as us burden BLA that that the cost. to other we for get have intention

Jennifer Kim

your And look considering responders that and the data XX-month complete into follow-up at thinking redosing, you're all the as does for how ability you Wonderful. play these pricing? Okay. and of current about

Helen Sabzevari

Yes.

and since complete redosing. and response, have required responders they data, data there are not we it goes. are see are So any they Number the yes, one, we the in receiving still as

we the responders, to very obviously, designing This patient. are very, very happy we dosing. In So for exciting, further and point, repeat addressing, we and design upcoming that the discussed pricing the at patients think. months the that the will we report about will partial be that's I what that would market something we to the will and on be address regard are and is the in are be the and arm

Jennifer Kim

Okay. on my just with opportunities. last for Great. And your question, parties discussions non-diluted

this to I about framework what UltraCAR-T mentioned or might -- and think is are that you collaboration, working the I something under? Is trying that guys. discussion, like terms AGXXX platform. and understand you be was -- then of upfront were where a focuses to you in of the X you talking more development guess research or just when the you're it what to I'm type

Helen Sabzevari

Absolutely.

AGXXX, II you also data have regards positive to commercial our and the So Phase prepared we manufacturing the data Phase manufacturing. III and as Phase know, in II -- the had for group had

prioritization that the the requirement had. to the because entering X of program of from re-frain had the program Phase the we However, and cash

that the past some superior we treatment. with into clear have antibodies combination and very data for is XD the and the In field that become shown has X.X especially the monotherapy the for actually as in both approval Type actually of of a the in antibody conjunction with that Teplizumab that years in it

required about not it's level for And attention. AGXXX development, I The become AGXXX And on sure. with we discussion are the is say in the -- of would talking parties. of a discussion research number a has And about partnerships. this of center

UltraCAR-T partnership. we similarly have In in consideration And clinical. view near the discussion we those. it's regard AML the a shown collaboration the in especially research with in or data that future some hopefully, are in to be and of addresses type taking into of potential will reporting we and of parties various that solid the, number of the That tumors, on on

finally, though, didn't I it I think this you ask can And add Jennifer. maybe even

And this We about -- subsidiary to also be on will to we further. are important the in non-dilutive cash think our from I a also divestiture our Exemplar. the extend very excited very have providing of now runway progress started XXXX

So readouts, only to those to are but to with have discussions data that our various further extend also by cash reality rate. not allows now hopefully means run extending XXXX, these our it get even partners run and the rate of all we that declaration will our that cash come we

Jennifer Kim

much pass Okay. Thanks Very it. helpful. very guys. I'll

Operator

the next H.C. comes question with He Wainwright. And you. from Arthur Thank

Arthur He

Good morning. Hi.

Helen Sabzevari

Hi Arthur.

Arthur He

for taking my Thanks questions. Hi.

difficulty, if the has Just before. a question been technical I apologize, asked

regarding more So your you I'm threshold think the favorable? endpoint, data program, the kind data XXXX what perspective approval think from is just what -- you of kind the curious, efficacy and efficacy of commercially is regarding is

Helen Sabzevari

last except I think, of and no from patient is for perspective other is in exists time There of number as a from commercially currently this. there. favorable, see surgeries this the over nothing of you there and can therapeutic that and over over again

a have this it of can with if disease you from if and means you lifetime childhood, challenges surgeries imagine, And this. that

be this currently all patients. case. cured said, unfortunately which to regard, population. had these been we that that not what And is by far the because should was now, surgeries So if they the patients it therefore, we first the efficacy, then In as to And have hope the have have that years – market shown on have benefiting the patient regard be population automatic but disease standing above on to be for if will going you response at consider we the patient we in therapeutic as as are a they And our that clear responder. X Phase FDN with is of lead surgeries alone thing one doesn't discussed that we to the patients regression XX% as have this from complete very even it's XX% that it's not these there. of the XX%, currently you regression are But rates. we the

I the as response. So XX is patients' are we Not by very from complete any have are surgeries. way But responses months a X, have or of and this response. only excited. responses we mentioned, very Phase completed our them the a a And deep required of ongoing none

Arthur He

you deeper little a study. the answer. Yes. And regarding just to the go bit for Thank

the pre-existing for did with make to their level monitoring body also the the FDA, treatment? patient. as any Vector requirement a a the color During did in requirement raised for they the for And of transition antibody the antibody they screening the upon put

Helen Sabzevari

in our FDA recognized We And cells. of already HPV-specific that And conjunction there both in but to And should no had as in already AdenoVerse readouts of actually mechanism Gorilla again, in with And very that to shown prior design, we the previous the pre had regard as is that this neutralizing the even importance I of healthy PRGN-XXXX. remind very we appreciated both regards these immunological in platform. and this which platform as is are antibodies PRGN-XXXX showing. well readouts, we uniqueness included have everyone to the immunity thing or one action the actually data, much Adenoviruse's. little T in volunteers,

January that is that that thing you will other would issues neutralizing the that it once give in PRGN-XXXX, data in slight the the with repeat we not twice. that extensively and down. you're now you limits other basically which PRGN-XXXX have see not a drug One we has increases XXXX. a both that only giving AdenoVerse antibody viruses, there you data in or and at platform And best to with ADX various having this have can or then therefore, showed And is upon for if dosing products comes increase shown used you

PRGN-XXXX Phase on instance, cancers patients in X we have HPV had T similarly, upon that they shown, in will PRGN-XXXX, well I HPV-specific Phase as for our remind a from cells their those And monthly basis. as everyone that dosing setting X repeat which

patients for platform We versus enhancing of retroviruses T-cell And the mechanism there. been the and have year of that treatment. the you keep over platform differentiation of this is this instance of the responses the on part all action other again, shown can exists ads have that that the other

Arthur He

Helen. great, I I That's if may a question. may, ask if last And -- I can

regarding the for that? US, outside current what's So the strategy market your Thanks.

Helen Sabzevari

for UK are share a there. the as with also rapidly the product EMA confirmed currently, have just to same moving we and license the at also token discussions and basically As the the with with drug PRGN-XXXX on a position FDA, Japan with we path with

Arthur He

questions my taking progress. congrats the Thank and the you. on Thanks for

Helen Sabzevari

Thank you.

Operator

question Ben next the with comes And from Stifel. Burnett

Ben Burnett

progress I you in And the congrats my very Thank throw quarter. Hey. will this on much.

Helen Sabzevari

you, Thank Ben.

Ben Burnett

sticking the provided kind a of durability of number Are with to to you And addition what response I FDA those I versus totality in focused is of in I are endpoints the past going -- how maybe the XXXX, that on on different other at? the CR guess they on they look focused endpoints that would XX-month the data ask you've PRGN is efficacy rate? shown? guess rate.

Helen Sabzevari

very I think question. good

meaningful, we months. was go didn't all in the the endpoints number surgeries. we went forward, of reduction a very quite provided months long for part and put we six of or three made a that no for of of we was period XX for time. required we and What is was which that First that which upfront a was months, for surgeries It not

require they severe believe population, patient three And to was did a which as one seen other very thing very higher. I we point which and a we that positive was surgeries went it

elements be durability with our patients. responders, those it So they following in especially continue together, shows we not only are full to of the And all well of months our they showing especially we that now obviously continue response, are and immune XX response. the past all

So to that and that XX-month beyond. response that durability follow-up the of speaks

this. X specific response to obviously, are to as trial. that the that entering have that from was again did we hand the to this a responses On associated and have we mechanism patients these think XX have a the the clearly action the that is other And not with appreciated responses leadership, because prior showed patient I treatment and HPV the FDA this they by in clinical fact full this data of due is generated

important. that become So very very, I has think

without obviously, neutralizing hinder in to this we the And days. event. between to don't put action, It of that to the increased that by have had the confirmation a that because give subcutaneously others, product the us antibodies, plus to antibodies the or of all the the AdenoVerse immunological it usually be in now and mechanism the is endpoints uniqueness accepting T-cells allows, way the ability that's you it's relates having Again fact allow And of also and have case difference considered with trials with neutralizing a FDA of we course differentiation huge platform. this over redose it And XX number the for currently and at which the allows as markers all increase we that this the see tremendously will the of opposite. and that therefold. and

Ben Burnett

have think redosing? Okay. guess, you efficacy really just course I this repeat would do relevant question like that database interesting. would also this constitute dose And you in how a a as, around repeat ask which sense point patients patients is Excellent. course of That's a modify a at very I you're would dosing repeat four I'm would or like dosing? helpful. the And many I adjudicated to dosing, be to assuming maybe that

Harry Thomasian

Yeah.

a had uniqueness with for on this the responders a I instance can various to of the dosing. that And a have vaccination we two after repeated trial -- you are that can it we becomes they when not fact you patients had over obvious PRGN-XXXX scenarios that can single receiving responses imagine period discussion year over because of another deep that require our and for throughout, Clearly these full course also that this investigators. doses monthly in repeat think patients very a that's they if receive we a went the receive and of platform. they on surgery fashion base with situation done years after and responders they received as we complete similarly they think that PRGN-XXXX. That for a for have patients that you have or can of then give

doing clearly, very will us very, we for you and into we this it's in the RRP. on is on arms population. also address that be every factor And is that be another we that can exactly do we can have population address or And the that whole extremely three patient PRGN-XXXX full important This it's And will basis a based imagine also to the repeat this if become months. the for monthly also population. can go readouts this important will appropriate to designing dosing discussions as scenario we you pediatric to and immunological can the address

Ben Burnett

updated Fantastic. the a And remaining study, that just runway separate? dosing great to if the one retiring Okay. confirmatory question cash could this hear the debt. with cohort runway squeeze fully I updated cash or costs and the Is cash is runway, maybe about now more associated expansion include the way on the obviously which just and repeat by clarification congrats on

Harry Thomasian

Ben. costs. Helen design include to as that. include, It that. of does of does Not still there we're some It the had said, to specificities But needing is contemplation those

Helen Sabzevari

the not also Phase point include can with will is I that, done initiate I exact be does remind it's after single to The our arm. again, that can the the and I because a Then everyone, to something does arms we we will with that expanded a design. have Phase at randomized be the III II. similar control Phase is Yes. it have BLA projects arms confirmatory initiated a but want later to discussed or not confirmatory, be as those say single design we a arm

of and considered our costs the runway, manufacturing. have of our purposes we part the for So,

manufacturing initiation by it some see to into the switching the As facility you of does own own our manufacturing the take trial. and our that, account address confirmatory are can we costs reprioritizing of

Ben Burnett

Wonderful. Thank you, so much.

Helen Sabzevari

Sure. Thanks.

Operator

the Cheng with next Brian Thank you. from JPMorgan. comes question And

Brian Cheng

From there need that then you follow-up have filing? couple to And my for discussion up of have between talked on can and preparation how on? are question about work I And preclinical a Thank that taking tee then you. the your talk do work work follow-ups. about the now filing morning. need whether for you before any Thanks safety you ongoing study you they the to in filing, additional of have team. Hi long FDA, this a of

Helen Sabzevari

Sure.

So follow-ups. in endpoints it's safety one-year regards to the similar that profile, to for we the efficacy have safety

Of be regardless as these course, following patients we have on. they -- we will move

So that mentioned as profile will have part product this very the in we are very I -- patients of very And favorable treated we similar of drug product safety and has have and the endpoints. favorable. all a those repeat, very,

part the for obviously, been is FD be preclinical regard but has with has It us has material are a I, point, taken the As of meet that the to going of to comparability in have confirmatory of asking far the this data also commercial includes the discussions, typical II, work and FDA prior point. part to discussion have any to submission, and criteria up we Phase we BLA is our a meet as to This preclinical submission is end for the in what a as place -- already to BLA, Phase all obviously which to similar obviously manufacturing, Phase the trial. II in we in manufacturing our clinical the the seen to using for.

we it ongoing. way So hoping and And review when all we course, moving has towards in approval, submit for components which to those discussions those are rapid will that rapid. our that are the we have of BLA,

Brian Cheng

manufacturing prepare that CMC front, anticipate? -- is your the to side launch, What's specifically we what the the on on of you time at then And Okay. can the your readiness? and needed elaborate on capacity commercial anticipated should

Helen Sabzevari

all in used PID even XXXX. trial by the was April of evaluated manufacturing XXXX during material we own trials because as pandemic imagine, Well, the you provided of way, the facility, our have I of time, can that the in on which, we believe, GMP this started

pandemic, So anything. important has manufacturing that external imagine very of the prepare during were manufacturing, you our shut no can point, that because was at prepared and down. all ongoing they could the one which

for have make of commercially the facility we I share move the that's decided our past this So to facility why for own basically path. to and as ready commercial manufacturing mentioned, license and importance, the our one

We moving on be our as material we will speak. commercial the for material

GMP ourselves processes also will be various comparability material aspects production. be of we manufacturing, obviously facility presented will minimally hope and and profile the Our and launch here switched. are a after anticipate the that have very we to approval FDA, Since our from which to have our BLA. working commercial for ready the of we comparability teams our good that on are produced we We

after our population at facility patient process, in approval the are to further that within capability U.S. the especially closes is We looking for And that this also, has should enough we that. the mention also I during produce and commercial expansion. obviously, believe

facility can -- we we is be it. needed our doses So production sufficient believe for in will be with that, of the that that

Brian Cheng

last squish Great. great. I can the in be one, that If would

Just around one portfolio. entire thinking R&D your the on overall

think As should have you you how are mentioned of what about to the that a the what on take to divesting have and you how the R&D you XX what And next portfolio given prioritize will currently there and opportunities off? about cash you we runway And partner XXXX, you. thank are you think talk evolve out factors And that will multiple that the when potential table. can to that over partnerships months?

Helen Sabzevari

Thanks.

So very clear.

and I had think very because this that that as far -- we we that announced on -- as is immediate very clear this previously believe something it's AGXXX exciting. is partnership

number active this However, a extended parties around is we discussions the Precigen does Phase why not this to go have to the cash requirements very and AGXXX. with asset X of with have

fast do AML Mayo continue that, this recruiting year. to that perhaps two objective the In the rapid to strategy for anticipate and PRGN-XXXX have a sides the and in and patients it's regards job path it -- to our advanced half we Clinic from and has the -- because track it's that of done will an especially Moffitt UltraCAR-T excellent regulatory I much the the more responses, the as in mentioned especially, they

for data XXXX. the Phase So we the minimum having interim for will be a Xb in data

us not only program commercialization. the groups in with that interested regulatory -- program rapid be in but the discussions this the advancement path move now to for of perhaps in in the Again and a right are position towards that our made a and have that are direction, from also decisions and

portfolio the Harry of I priority know stress I and to this want stressed. The has

We of really minimized have costs now the SG&A.

some in cash large CRO extraneous one requires by of you an in by heaviest the that drive as initiating and sites doing of your all immediate minimized we have it opening limit development sites not costs are the a is not the We that fashion. to the developed -- cost know

get it X, of just requirement is you it's our point the another of the We PRGN-XXXX the readout why three decision data. are to to and which of which get saving have imagine taken would four the years us appreciate to so important can The because to as of eliminated it to is FDA Phase I or mentioned.

FDA And our we finish data of has an side. now basically because we endpoint is XXXX. right will are first are which agreed open secondly, complete Phase XX from that X quarter as second we seeing months And all, of the speak with it's -- we the of by follow-up the

allows that. beyond cash extend non-dilutive well productive with cash our runway From beyond is a discussions us definitely that will fashion to and is runway that very we our our And readout BLA submission. have, it So our and XXXX. move, ongoing. our have is the And hope

utilizing. that's which boost do and to that need immunology and force a the hire And retrain move the in have obviously we a side, commercialization. we that not have think they now on that have I'm clinical I are the another to and strength has towards they lot at development, tremendous of they side to what of shown. asset that that, is in thing Precigen our of say, we a and team I have not immunological, other companies lot the And R&D of -- knowledge because dedication on which for is other typical to the have taken rapidly pivoted time responsibilities order Precigen done to especially One grateful

Brian Cheng

Thanks, Helen. Thank you.

Helen Sabzevari

you. Thank Sure.

Operator

concludes to this I floor Dr. like to closing session. Thank the turn you. for the Sabzevari would And comments. any question-and-answer

Helen Sabzevari

Thank you.

today. joining the thanks trials, for First their worked like at to and who have I dedication for therapies for to would investigators our clinical years. patients of in unmet over so our studying new to thank all, participating for the our commitment needs extend team us to Precigen, want several the you working and on I hard last

potential paradigm-changing with our study. today's the stage medical FDA announcement bringing our need. a discussed important brings a of an therapies on believe that transition path of is with our and we accelerated for to company, in X/X milestone vision This today, have request commercial a step the unmet life-changing PRGN-XXXX to ongoing to an alignment Phase closer a us in As patients realizing we approval has and

is up Given decades to as for enrolled waiting you pivotal who fully option sets potentially this again. patients option. that X/X have us and the RRP serves life-changing Phase such for an a first for Thank therapeutic been bring

And operator. it now return I to

Operator

The for Thank presentation. has now attending you Yes. you. conference today's concluded. Thank

may your lines. now You disconnect

Precigen (PGEN) 9 Aug 232023 Q2 Earnings call transcript