- Earnings call transcript Q3 2022

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Operator

Good day, and welcome to the Precigen Third Quarter 2022 Financial Results Conference Call. Today, all participants will be in a listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note that today's event is being recorded. I would now like to turn the conference over to Steve Harasym, Vice President of Investor Relations. ahead. go Please

Steve Harasym

update and our me operator, XXXX and for us Harry pipeline our provide joining Thomasian, have review progress Thank across will upcoming made Dr. thank results. milestones. Helen financial With our an will Helen are of and CEO; quarter the Sabzevari, today. significant CFO we highlight you, programs Precigen. you on anticipated President third Harry which and After

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

read we that Investors differ a will cautioned Harbor Precigen's statements. are Before of note and make complete in could Helen? -- various and risk that indicated statement press well statements to Dr. uncertainties for we forward-looking in please today's these factors and call, turn risks release actual expectations I contained Sabzevari. by that filings more begin, our the SEC during forward-looking subject those Safe current forward-looking are will based as to could now as from to uncertainties. that the results discussion are call cause statements. risks on such recent actual Please most the

Helen Sabzevari

you way us most our significant of and greatest the here at for for Steve, is you our offering report and Precigen in focusing in portfolio on I'm Precigen, while Focus increasing strategy is value efficient progress the XXXX, potential that joining on thank to pleased to during straightforward. Thanks, the quarter shareholder today made today. possible. third mantra the assets

and potential we markets for high are the offer The developmental on need. ultra indication with focus we pathway. First, an accelerated regulatory pursuing unmet

treatment higher decisions therapies sites seek also manufacturing, of development The from focusing operations and to we to need provide and continue especially a access create away by decrease patient figures consistent with making concepts population. suffering our multiple move difference. to are from early of manufacturing patient a dealing our costs traditional with into when where to big as at to centralized ability Second, population decision-making success. manufacturing We makes earlier product we therapeutic research, pursue probabilities broader we diseases

differentiated we therapies but about is as Finally, and paradigm talk in proving in utility, not technology potentially also we only advancing on development. pricing their I their be change that UltraPorator in are how with are the the focused to manufacturing our changer value-based era we when that game new system. overnight future manufacturing comes a are want distribution. a it care of enabling We of to requirements our meet local products entering that be ready healthcare and and to will believe

Another towards resources is cost I we now Thanks area focus our are the of efforts, reduced and programs. our on you update to clinical commercialization now of SG&A will clinical have our allocating and discipline. fiscal efforts. further

at a for for AdenoVerse patients many function. temporarily these spread disease with problems the patients RRP. the immunotherapy Recurrent treatment recurring time in unmet medical very condition for Papillomatosis and remission. increase The severe options these for a has option urgent breathing and of RRP First, surgeries platform, surgeries of need significant the There virus, been as designation surgeries the can can or with life cost. worsen is surgeries an including overtime, of PRGN-XXXX Comorbidities, as drug hundreds the lead as recurring of do the our RRP therapeutic is with to the orphan it only Respiratory RRP, remains on requiring only These immense not actually leading the lots to such local PRGN-XXXX. PRGN-XXXX the symptoms devastating burden Furthermore, patients. of high orphan need treat

March and XXXX, on dose Phase are We program. complete this To escalation COVID-XX the patient study highest we the of dosing patients' dose recap, There the course first the clinical of progress X during profile four dosed XX dose-limiting in rapid in receiving heights treatment-related and and follow-up pleased are all than expansion extremely pandemic. Phase with the have PRGN-XXXX full has cohorts the Enrollment an with administrations. demonstrated with adverse with greater XX-month subjects been PRGN-XXXX and Grade completion. X. treated treatment with X no events toxicity excellent no safety near

at JP what a We be opportunity are efficacy will Morgan safety dose market to cohorts drug looking forward from timed of believe R&D we believe significant and in data Conference. We which the is early event Healthcare this coincide in RRP. and is the there January XXst compelling PRGN-XXXX to Annual highly the expansion virtual escalation XXXX, presenting with for

cases. Our numbers of XX,XXX the patient population and XX,XXX. approaching of case EU are could there global over We bring is juvenile substantial U.S., the population estimate EU outside that the feel to and U.S. adult

market on limited due These numbers prevalence awareness could a over We the to disease reported of lead pleased date our II details of estimates, enrollment plan I'm the opportunity EU patients alone on U.S. also Associate enrolled the with provide is Dr. Senior the a $X and Clint the and patient of opportunities This at that population, Investigator burden date. rapidly for to believe market Phase of presentation. study that same and for XX clinical disease present would in preliminary this to disease. At billion. further patients Lead are PRGN-XXXX Allen, report time, presentation. understate true we progressing trial Investigator to NIH the and during the the will

various with the medical Given need evaluate path we this patient unmet have ongoing in for high FDA. been the to population, discussions regulatory

anal first Phase population data Phase is diagnosed in presentation newly combination ongoing. XX cancers. including update checkpoint in cancers, and and to HPV-associated monotherapy I in ongoing potential data both has squamous in Based our a partial in dose immunotherapy inhibitor XX XX I the and patient encouraging patient is thus patient estimated XXXX. and HPV-associated All to Interim demonstrated broad checkpoint malignancies, II are were rate, arm the monotherapy with cervical, an completion are multiple and inhibitors. anticipated on prior a hosting an cell with data neck the patients address enrolled, that encouraging from including respectively. we completed recurrent safety I the follow-up X and half failed previous cancers to metastatic all objective on patients nearing combination efficacy Patient Phase Immunotherapy oropharyngeal or failed and attributed a on therapies, the Phase six response XX% with far, carcinoma X% in PRGN-XXXX or looking of of head follow-up enrollment AdenoVerse and investigator-led in and treatment. cancer. for Stage HPV-associated has Enrollment complete patients forward arm We responses which PRGN-XXXX, Now our

. David Cancer completed enrollment Phase dose Phase the December trial investigator and Solomon in UltraCAR-T escalation our Moffitt data to on will refractory ASH turn lead I safety for AML efficacy cohort of of the the patients. now relapse at the I in We PRGN-XXXX Center study Dr. present Phase Let's XX, for I/Ib study and PRGN-XXXX XXXX.

study. are of the patient relapsed/refractory patients of We by new with are at at in this in population. successfully the has significant represents And and expected PRGN-XXXX the first to Minnesota, encouraged potentially which site. first as been sites dosed to Ib to was The presentation expanded this Rochester, the several expansion forward to the study Mayo of of AML, Phase looking benefit a multicenter part UltraCAR-T results date Clinic patient this extension

well proof-of-concept us Precigen centers announced, with as important as Clinic to a for game Site This scale study. across we track refractory FDA Additionally, at out patients and field milestone pleased immunotherapies, AML. centralized phase as for as is an for been UltraPorator. manufacturing UltraPorator clearance the the the cancer a previously in such granted we for expansion PRGN-XXXX drug US. partnering changer the has dosing the well in are that to the received as advance Mayo major development. of of as additional relapsed orphan the field, as its the UltraCAR-T fast designation demonstrates designation is is repeat overnight incorporate renowned institutions this are it activation with using several progress of for

for and arm. of the to escalation complete as Phase Now first in our lymphodepletion X well cohort as CAR-T is in ultra dose in we Enrollment ongoing, is data intraperitoneal without X be Patient lymphodepletion cohorts for follow-up the IV XXXX. the PRGN-XXXX, arm advanced the cancer. ovarian intravenous expect in the presented treatment of Phase and half

This week study. the response therapeutic the is during and some I we population cancer repeat in recall a participated You in clearance to an in or There in extremely dose quarter have that ongoing report pleased been at our current has with less first announced is Enrollment panel that earlier are may via important this in opportunity a patient to Site believe we with study for in remains clear of activation need expansion unique the we tumors. that address platform, cell study unmet in the is limitations. IV XXXX US, We repeat and call, infusion. significant and in to prior gene these there our space. at for incorporate a FDA's CAR-T received this therapy, second rate of to with dosing advances of decentralized lymphodepletion point using major Dose Xb another prominent treatment. progress XX% with overnight including patient Level And ovarian the UltraPorator. cancer City Phase X the minimal this solution at UltraCAR-T innovation in centers multiple is infusion. the manufacturing have yet it solid UltraCAR-T figures scale-out our validation with IV of

and look PRGN-XXXX on addressing XXXX at I and checkpoint X/Xb CAR, inhibitor uses regulation in eliminating trial-in-progress third over the IL-XX Phase PD-X solid PD-X Harry, The dosing UltraCAR-T is and this tumor inhibitory kill combination. is expression study a, our which forward track the trial being December down initiate financial Finally, XXXX. in call in hematological UltraCAR-T a effector quarter microenvironment need on Intrinsic to tumors. advanced the a and evaluated review XX, and tumor switch. to will PRGN-XXXX Harry? three now will We genes our solid highlights. for treatment investigator-led an the our who hematological incorporate presentation of of intrinsic quarter. next-generation is at ASH membrane-bound turn RORX+ the blockade to in PRGN-XXXX, of addition to technology umbrella the

Harry Thomasian

to like the and quarter progress strengthening I'd we've to balance start all Thanks, made Helen, the by good and on you past sheet. over great of our the highlighting call. afternoon

announced, have open convertible outstanding our our market XXXX, notes In during that balance quarter of of we repurchase notes, executed debt of through regards million. due average the the to and volume savings million bringing repurchases, the wholly-owned consideration the from for third quarter, Trans the subsidiary, Genetics price ability to and to future the activity a the retire date, $XX as savings convertible have our interest weighted completed we sale the to into us approximately stated operating during today our Ova over proceeds As of was third provided The quarter $XXX The sale on third of we million. like previously through are par discount $XXX those July I'd the Taking notes. results convertible realize XX.X% opportunistic time this of today, outstanding maturity year-to-date. some also cash aspects $X.X highlighting and for certain par. will spend to retiring our of million.

Ova's case results the beginning As quarter. discontinued the as historical Trans as are second a reminder, reported was operations with

relates previous on These it over to the borne a costs. specifically fruit. have variety As we couple have of years, calls, reduction of initiatives initiatives I've SG&A our stated past cost as pursued quarterly update

we can to to and in of future you on programs those in the these able comparing such costs reductions quarter-to-quarter advancement our prior and now have our potential financial the of year-to-date respectively. focus commercialization expenses and are As X% year-to-date, statements, programs. X%, on continued costs, the Based SG&A decreased overhead by see our

non-operating was notes, year the for September nine the lower for and prior three expense XX, our with convertible the retirement As XXXX, versus periods. expenses, months interest ended of cash

year through fourth will significantly and the this half at remainder next our first quarter be lower year in year, cash the expense the notes. of maturity interest year remaining of of Looking the of this and next into

with to we fourth look the Overall, have strategies continued with and take clinic. our we early cash With of equivalents, This is debt, the restricted of cash, success product was of of happy million. sale remarks us cash than candidates our and $XXX.X to our are stronger Ova and sheet earlier been retirement this successful through That quarter provides cash the implementing much in to We Operator? questions. the part investments Trans concludes our moving it for date, year. quarter ended today, short-term XXXX. we now into runway your forward and prepared in third of the a balance the

Operator

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

Jason Butler

for and Thanks taking on questions me. Hi, the for Two progress. congrats the

us color specifically baseline can all, the Phase into XXXX, of on II First of their on then the safety more And the -- enrolled Thanks. terms secondly, you for on characteristics you and about so in any patients patient far. procedure who trial retreated any successful? just us can say the surgeries. you was can XXXX, give And give baseline color was anything

Helen Sabzevari

Sure. majority least Jason, actually with have They is surgeries than XXXX, them of cases. we PRGN- treating more, the been patient in that Well, severe HI, the regards much are that. to have the at patients and more population but the three most

six requiring been on monthly have them surgery. report to weeks four continuously almost And some a of

as dose patient, consecutive both was will we early no cohort, did -- our not the trial And the a the but we about that the treat. someone on expansion have there population actually the disease, be I reporting that if patient discussed. contains we as it after which, the on except we on way very most in And of we that patients data is to upcoming very, wants also mentioned, escalation, -- what excited really on will mentioned, this but I surgeries. obviously, to is say the from So will in safety, very is a treatment that difficult for go perspective show are an

what very to. this to by I've they a to hundreds have And them, have disease while And to are very well, the after just of treatment patient followed and as and continues a And we can hundreds patients continuously. and this very their no difficult the has look have doing surgery our absolutely surgery really point, recurrence this well, had up matter imagine, excited. life. -- is is as the been as throughout been of dose. you And forward is is of very, Some have this well, the redosed treat. removing a to dose PRGN-XXXX In the -- received and these and regards we doing -- infusion, IV first mentioned, patient actually second patient back and it and well there

prepared the some going year. as mentioned and coming in the a meeting exhausted CAR I are manufacturing half sustainability very we and field ovarian. solid a of tumors T the cells was the came the has are around and tumors clearly point ability very not not it tumors the City in remarks, are that cell the solid into this mentioned nothing back gene of to the excited reports the that of just how I and renowned at basically really people for for So at And overnight it the current address anything from including the first as these in special the able our the discussion solid this actually, therapy and such next And of actually in with was panel for field.

especially time So, with look And it forward us. year. we to for is a the the presentation tumor solid exciting next very -- indication.

Jason Butler

Helen. all Thanks details I appreciate the

Operator

The next Ben from with comes Stifel. question Burnett

Ben Burnett

just kinetics, into will And you AML abstract also expansion for on Hey. two some for -- some your you was the a all it made ASH maybe talk I it around separate two much. went Level about focus product a the folks multiple Can I the and what decision get dose what Will ask program. be you at discussion patients was and question the very clarification. remind Can doses, will into program, about doses? runs? Level there's I manufacturing And efficacy? just on AML it's for just but in UltraCAR-T to Thank -- expansion to wanted the to X? maybe once decision me X guess and be split think

Helen Sabzevari

Great. Thanks.

PRGN-XXXX for and the X that really Level on, based was first we all, all, on decision reported. of dose First of the efficacy

Level If X, dose at XX,XXX already XXX,XXX basically that talking objective ASH to and year, objective you XXX,XXX per between responses. are kilogram. responses, XX% to the And X million -- levels have about last dose we recall, the to or we XXX,XXX already X we in XXX,XXX shown were

that So, was very infused low doses. around The maximum have XX we dose million.

especially also therapy, with seen not So, of because which both of not this millions cells, need these and hundreds of to toxicity and the of platform, ability the cells of billions type exhausted, that outside. don't very severe that neurotoxicity of we CAR-T. the the cell leads infuse other and and some are the do they been B activation believe We has CRS require to

was positioning and efficacy, number So, clinical third sufficient the the orphan re-dose and for and us we we on reason track based for we and in position, a data, dose well go looking the in after going efficacy would patient very believe from stop that as main this fast the a to at the we dose escalation has at data both and larger there. very rapidly know, you reason, for especially designation efficacy. and Phase we patients but larger are after drug, the a population as especially as to And our of with the safety And efficacy, dose that have include it's to therapy decided that both that. that and data the have good then third ability still X expand still the be the on safety, encouraging level Because with efficacy.

kinetic these of expansion. ASH cells last cells that We reason the was incorporation our our expansion we faster and has believe, through therefore, And course, we of shown dose another of third was that, year. Level Dose – lymphodepletion that to to the the the that also expansion of showed sufficient also of much had in led go

with we number next on Clinic that months. board will really of a are few the come other now having and be So looking Mayo clinical joining us centers the in forward major

obviously, and first looking in sites been able field have rapidly. what able you cars recruiting manufacturing to sign patients and really the this a This And time, decentralized these being I are ultra the enough. for that do at first the various We manufacture stress because it to in This time PRGN-XXXX and is first is is overnight. cannot exciting paradigm it is us sites. And dose. really the have the that And a this one side here. now you not about the shifted is for re-dosing anymore. of the This allowing asked number what split and we if

obviously, there are do number currently, can that this. you a of ways So

You we you you back working have process at that. move generate on And then that and also and split cells can that at can towards T ultra dose the and want. your freeze it time the been once cars

is need But not number cost shot platform lot and what the current, is as but it receive the allows impossibility of points concept work the is a And times if for unique the multiple patient, only development the makes other per concerned. ability as it. companies, far is at of treatment unique and this is, a almost I are is $XXX,XXX, those shifting. think for different. And different they at cost of us, to to receive the doses, the this this the So paradigm able Because Why? process ongoing. to re-dosing $XXX,XXX provide which basically the is we again, as

Ben Burnett

initiating super I for gating UltraCAR-T just RORX to That's can on that? what's And if helpful. just one I XXXX guess ask Excellent. Okay. dosing program, patient the more

Helen Sabzevari

had committees. Moffett the lot in very been that be to and their for various a open. has that going It internal frank I'm So changes processes and they happened has of

set is passing manufacturing basically, our place. are Our and investigators ready. the just The broad taking And is that there. the now through and product committee some of last it's is bureaucracy

Ben Burnett

Understood. so Okay. much. I Thanks appreciate it.

Helen Sabzevari

course. Of

Operator

Arthur [Operator Wainwright. Instructions] is He Our from H.C. next question with

Arthur He

RK. Good and on is the Helen This Hi, team. Arthur for afternoon.

Helen Sabzevari

RK. Hi,

Arthur He

Hi.

patient the the remind you dose my on average, Could And is date? XXXX first the received for the cohort? the many for for is question first -- the XXXX? dose regarding level us So how expansion what's

Helen Sabzevari

Yes.

XX our the infusion, the to apologize.\ basically So or and patients our infusion subcu the received of course to dose Xx XX levels be it's injection. four sorry, not I

Arthur He

Okay.

Helen Sabzevari

sent ALM with the So of four to and is the that times them. five to course

Arthur He

a Got study, of I efficient it. stick the Thanks regarding FDA to with And data? the done. enroll registration would the noticed that XX X you to that the Phase tend for up size that the be you for clinical patients study, Have trial as that. like how to according for

Helen Sabzevari

exactly expansion this are FDA and that molecule an regulatory for seeing some in That's discussions the are cohort. to regard efficacy the the we excellent path that safety view in in of of having the with question, that's our and we

Arthur He

my Okay. repeat and Got XXXX, dosing color. Thanks for both regimen. repeating is the And you. last -- for question the XXXX

how interval at you for determine or patient the dose for more the It's curious, it's fixed the Just guys the schedule more a patient. repeating for dosing the personalized physician discretion.

Helen Sabzevari

within almost the and infused still there has gone. a cells billion number a much it's that had weeks obviously for are with Excellent maintain conventional the and that. of has the as Yes. And close with that off is lymphodepletion, cars, off if two the cell as know, time they shelf. which time the or they with that one heavy there each because up dosing issues million to once $XXX three and data reason of all can weeks does, cells the receive themselves, shelf, multiple don't the is sustain clinical shown produce the three goes are themselves for first eventually, they how very see that upwards do at hand-in-hand you The you they the look the very, talks. the ones and Unlike question. every with and X only that's And week pretty because they

continue in need do they in a expansion manufacturer member tumor we We do upon we seeing mentioned, IL-XX, the bound the don't and because as any absence with also because while expand then and kinetics patient, but and have with weekly are have. So themselves shown kinetics capable circulating you expand, that of they ourselves to or the sell instance, follow-up we the of tumor, and actually membrane-bound directly for they can antigen as patient, period over again, to of sustain to the get the antigen, because, have of basis are a inside this of on view, they the don't ILXX they outside. time actually a been that it in redosing site the the

for those discretion action settings, not the So those do the is oncologist of being at differentiated off-the-shelf difference a off-the-shelf, the the we the ours basically settings, need of of you it in a to very to do mechanism happen. are what takes need from to the UltraCAR-T. number -- of absolutely infused this redosing with reasons, obviously, have because they there see and because case And and our do in the of And that. log we result, tremendous and of In of cells difference in the is this need the hundreds much the the a of how again, are patient. billions millions are still there. that That's our of as

Arthur He

my thank the congrats Awesome. and and the for additional Thanks progress. on for color you taking question

Operator

with Next from question Cantor Fitzgerald. Jennifer comes Kim

Helen Sabzevari

Hi Jennifer.

Jennifer Kim

questions Thanks questions here. for have I on few progress. XXXX congrats the everyone. and assets. my Hey a taking the Maybe

give greater a around January, to that potential with of in coinciding believe color is level pathways? able data expansion you're to present early the also R&D you'd exciting of event regulatory expected the when be timing those Given you

Helen Sabzevari

not this an But we any That's in can because as to soon what pleased this are point, and will currently in At question. the the presentation data early obviously, patient excited what this make we yes. say our both regulatory can January. to to I can, we PRGN-XXXX, forward make is and are comments and present this is for But to in that. looking regard definitely aspect. will we I comments showing that as excellent we safety basically regard investigators population think, I in really regard efficacy, are

Jennifer Kim

the few XXXX have then fair. Okay. asset. on a That's I And questions

in the terms line takes anticipated expectations been in that all the to And it all with that my is done? terms UltraCAR-T, that your the this asset activations, is of Ib, to done still second tech Phase that activities site decentralized then First, get in of the dosing how start transfer in get it question has takes timing this to repeat those year? for that in manufacturing for like long

Helen Sabzevari

ease repeat, first transfers. and and the whole any all, of of can was up platform when me taken centers this Originally, been this the transfer be can the to clean any almost the in to that very something a the such cancer advance be way of this. it technology was like in and has the let had dream that. hospital room on considered tax even do beginning, take concept And achieve though basically tech Well, that the designed at platform a

only actually of to almost we to these Phase the trials, the capability this show have -- of there. kinetically expanding that it, also preliminary but starting in X.X are signs manufacture be shown thrilled post to so X, and not it We years patients UltraCAR-T efficacy

SOPs the center we that have to the is we to is provided to and tech regards in yes, Now, say anticipated what the answer had self-sufficient. transfers, I

cells. to not at manufacturing Our the teams are site of actually execute these

a staff the in and transfers of tech So clean this do not the hospital, SOPs, developed lengthy have that is do. the room the that and we through time. they And that the we

with We tech months you, shutdown, about continued overview. month COVID, And are training, I about manufacturing talking of sites were we actually, we our can tell when are we transfers. every talking not that or during did the six

sites semi-closed which this is So pleased. the rapidly. technology, platform, basically this really of of advantage And which central allowed has makes this system, is are part incorporation move UltraPorator, very of the and also the we this to

that that We see have in XXXX hematological as they a XXXX. the out, you out both our actually months coming trials start roll patients. for number they now and in will few and are of enrolling next And sites

Jennifer Kim

Okay. And more question the then, if I in XXXX. could squeeze for one

that Specifically those I X, the data updated that upgraded of patients, in we meaningful abstracts? in beyond data? -- expect And how level what kind revealed was what the at can presentation the ASH be guess, can to dose

Helen Sabzevari

doses, see think and without I complete the you all will lymphodepletion. is what with of both in

of only having of the basically being and population. most safety set some efficacy this that think patient I in everyone toxicity, is -- the no also not the but

to a As before failed three at have of have to population you some they all four, this that They point. know, and is five three failed fourth, treatment or live. are all to has a have months these two transplant if multiple this minimum also not fell stage six, bone patient marrow

no responses front have be in reporting of patient. And I science we of important. in population how UltraCAR option and see will this objective really the of think is directly on those in working they patient extremely the them. some to also So is And the

this quite us. exciting for is an So part

Jennifer Kim

Okay. Thanks the really helpful. quarter. and That's congrats on guys Great.

Helen Sabzevari

you much. Thank very

Operator

we this I session. queue. turn in showing At further closing Sabzevari questioners time, Dr. over would back to, are question-and-answer now like this for the to the our conference no And any concludes remarks.

Helen Sabzevari

Thank Operator. you,

made across goals As we you can pipeline clinical this substantial year. progress our and corporate see, have

operating our lead towards debt our a commercialization. reduces on to of our fiscal maximizing and add capital the our to balance discipline balance clinical programs sheet. Retiring through sheet continue focus and We drive substantial and overhang additional portion to clinic

escalation in side, anticipating and dose the releasing On X Phase January. complete we data trial from PRGN-XXXX are clinical the expansion eagerly our early

ASH forward programs We looking presentation at in to the are UltraCAR-T upcoming true for December. also our

the deeply support we are from shareholders. always, As our appreciative of

a creating to you. to market towards prices value differentiating unmet medical the with strive bringing Thank address focus in to shareholder continue high on the need. and We treatment

Operator

has for conference Thank The you presentation. disconnect. And may concluded. attending now today's now you

Precigen (PGEN) 10 Nov 222022 Q3 Earnings call transcript