PGEN - Earnings call transcript Q2 2021

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Operator

Good day. And welcome to the Precigen Second Quarter and First Half 2021 Financial Results Conference 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.

Steven Harasym

operator. you, Thank for you today. And joining thank us me Dr. With is of Sabzevari, President CEO and Helen Precigen. an significant will on made will XXXX update Helen provide the quarter first pipeline after financial results. second across programs, progress which our I review and half our have we

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

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

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

Helen Sabzevari

And thank this call Thanks, hope the their stakeholders of our listen all family I you, and to taking Steve. well. today. points in everyone, for as time

the and trials. in feature to be We readouts the to first stated announce in coming in our our that remain clinical team half. in X Precigen data about anticipated for year company's milestones pleased presentations progress, will will advancing to November made will happy continues the our dedicated call provided of goals key of meet Update track our the with investigators will This Today, or rapidly year. months. this multiple progress exceed on the call from further clinical for pipeline. clinical several The portfolio an on reviewing Details I'm Precigen host with are R&D to Call the achieving second clinical and extremely milestones advance year-to-date our half important

of some advanced would received you of either persistence or favorable platinum-resistant profile without Phase III/IV arm as IP level the like intravenous addition, updates lowest of expansion the trial to reported subjects safety encouraging infusion. for fourth we no Stage in and I in PRGN-XXXX in I cancer. regression Enrollment through showed at infusion, and treatment burden. evidenced tumor a clinical previously data dose with Phase Study X the IV and pipeline toxicities, release the level UltraCAR-T of Phase evaluation ovarian the a is from I further dose target escalation of the recurrent lymphodepletion dose conferences portion X-dose dose-limiting the under syndrome, updates. cytokine clinical quarter. now the neurotoxicity is via X trial ongoing IPR intraperitoneal Preliminary arm in In anticipate in concurrently. or PRGN-XXXX the take level by medical activity total I/Ib

the Study progress levels PRGN-XXXX interim from and with was trial enthused data and PRGN-XXXX Phase I I XXXX. the program previously is or in Phase the presentation of overall in of DLTs reported and for orphan reduction by a activity, this as PRGN-XXXX persistence data escalation fourth are showed quarter cohort FDA. lymphodepletion clinical the cohort the anticipate favorable the tumor profile blast the of patients We of lowest neurotoxicity, Preliminary two lowest and encouraging in UltraCAR-T subjects the dose dose of refractory UltraCAR-T lymphodepletion. with the expansion with safety AML. the levels. AML infusion, or myeloid currently trial drug level received by with under granted dose no a for the AML without designation Phase prior the clinical evaluation patients leukemia I/Ib with relapsed for PRGN-XXXX either or acute treatment or in in non-lymphodepletion evidenced

non-lymphodepletion a we at last persistence. ASH observed patient long-term stable in reported disease with year, As durable

trial complete response, immune immune lymphodepletion million at Phase anticipate Phase the dose to of level being cell with we objective This at the National with from HPV T Preliminary UltraCAR-T Enrollment Research off-the-shelf PRGN-XXXX, response or progress of monotherapy cancers. in fourth the are response monotherapy PRGN-XXXX combination Preliminary dose the tolerated arm. with exceedingly presentation in of administration the reported bifunctional in an showed HPV-specific that AdenoVerse in differentiation antigen-specific designed Cancer is I monotherapy the Ventra correlative and X our response. Phase boost responses. to trial Cooperative the in monotherapy only the currently in We with an well hematological of of lymphodepletion patients DLTs. and well, and highlighting in increase patients generate under treated of associated a Development the cohort the durable was clinical from X as is is AdenoVerse Agreement, non-lymphodepletion escalation with under continues data Institute. data magnitude in and no the I with [ph] lowest also was concurrently. X patient conducted and trial alpha or ongoing with the recovery incomplete lowest an treated the arm The showed HPV-XX level repeat robust plus target CRADA, and dose immunotherapy, analysis of platform dose evaluation dose increase a breadth to interim Furthermore, reported reported and PRGN-XXXX antibody, XXXX. a the quarter in HPV-XX, I/II cohort

date. the pleased of this extremely We trial are with to trajectory

evaluates level, have treatment. been line is patients This responses or Phase many with is quarter trial adult trial infected procedures. initiated. ongoing. Four one of of ongoing. as difficult-to-treat squamous requiring diagnosed repeated trial immunotherapy the the to cancer designed oropharyngeal XX our in Phase arm ongoing, was dose PRGN-XXXX complete, as disease X+X patients with have dose elicit RRP dose. subjects the conducted therapy dose dose I PRGN-XXXX adjuvant the arm AdenoVerse diagnosed excess surgical Enrollment arm trial I received up HPV-XX clinical Phase the cancers Just for a no tolerated six the The under with to some current metastatic for being fatal patients is findings, multiple the doses patients adjuvant fourth of or in per cell is we orphan of and arm is a of trial NCI. surgical is four escalation year, study of COVID-XX Phase designed receiving expansion immunotherapy I/II and followed papilloma with the sinonasal This to Phase PRGN-XXXX. Precigen of is the dosing progress approximately an six with presentation identified. for patients date. for interim was year year, also monotherapy with to and visible in XX ongoing PRGN-XXXX Patients papillomatosis recommended with XX,XXX living well safety as of FDA dose rare, A patients in the with immunotherapy enrolled of I drug a Based treated as Enrollment in these recurrent Phase and enrollment HPV-X primary maximum enrolled against in of the in surgical first AdenoVerse removal II determine II XXX PRGN-XXXX, is three II last This treatment PRGN-XXXX designation HPV-associated anticipate for a II sometimes or recurrent the I lesions was as RRP Phase follow patient standard-of-care CRADA combination I at date, Phase with all There [ph] the neoplastic the DLTs, is with RRP. perspective, each to patients the standard-of-care at new is with and The first II injections lower PRGN-XXXX to to Phase cure the cells off-the-shelf of objective put newly study an on XX We date. cohort and immune X,XXX US. newly Phase the patients to treatment tolerated upper in monotherapy the PRGN-XXXX. to respiratory escalation recommended enroll or trial And in PRGN-XXXX tract. trial. patients directed monotherapy during the designed is August removal of reported of in patients this following this we Phase the respiratory of is papilloma. RRP. in the no pandemic. disease the and of tolerability of XXXX. receive data to The enrolled by in

dose-escalation We first completed adverse of combination cohort year. patient initiate of January, I to dose-related early-onset ActoBiotics currently monotherapy are Ib expansion portion We endpoints monotherapy the I study dosing Subsequently, patients. Ib program, met. especially are were this and dosed. immunotherapy as maximum portion with Enrollment these type prevention, that we trial of teplizumab for primary and or of the I'm to Phase for the this in No both and of the Phase this trial. And the events these in TXD to at were the is pleased X reversal reported in goal tolerability the our the trial adults Phase need of the or and of that enrollment the dosing arms serious treatment IND progress of and we disease-modifying, assessing under medical Phase potential or this about in complete. Phase in announced the FDA the Phase dose, clearance either in TXD. were studies the announce is for AGXXX portions report exceeding of orally the events March, both given trial. adverse this safety In of IIa of a an diabetes already In trial unmet IIa have Ib/IIa delay for clinical or and have antigen-specific combination adolescents. pleased AGXXX Phase evaluation extremely was in administered trial. tolerated commenced in we excited

In Virtual clinical the in addition, Annual and for Meeting trial. Principal by increase School C-peptide Clinical positive combination Medicine levels, showed top insulin this and the monotherapy AGXXX as progression. from a Kevin TXD of stabilization line XXXX a of trial disease Society clinical of presented at or biomarker of of Yale were Immunology Harold this Investigator Dr. Federation a data

of Harold's suggesting a with the T these results to AGXXX the very production of responses, and underlying disease-specific oral treatment on of immune ability cause manner Based onset AGXXX address presentation, tolerance the potential precise a modulate insulin a patients. to antigen-specific encouraging recent indicate TXD. of Dr. conjunction TXD addition, system preserve patient's cell the induced AGXXX in to reduction in In antigen-specific are in

advancing to TXD for We AGXXX AGXXX oral of are treatment of assess patients. prolonged looking to forward the efficacy

or Diabetes EASD present investigators Annual October Our at the clinical to plan Meeting additional from on Association XXth this of trial the for data European X. Study

Now results. I for turn an overview the over our call of to Steve will financial

Steven Harasym

Thank second the you, even Helen. our million improvement to in financial I months Trans of Ova our first the XXXX, subsidiaries, as as the Precigen. Precigen and June pipeline and requirements Exemplar same ending would In development both cash of to in million of implementing during measures at began XXXX, XXXX compared clinical preclinical is efficiency to quarter like and activities primarily review from contributors XX, capital which our for reduced This operating improved be net result the net performance briefly we continued $XX.X period and to six $XX.X accelerated. both highlights. half

clinical programs gradually our our in quarters continue requirement cash increase to expect net the We progress. as to coming

I'd of strength to the capital our with anticipate concluding turn we XXXX million sheet. and $XXX.X and began sufficient to with back investments. to pleased And that Helen support our are cash balance now cash well is guidance balance needs reiterate QX our in We XXXX. like remarks. We call the into our for

Helen Sabzevari

Steve. you, Thank

conclude, our I update CFO a we provide you to Before brief with search. wanted on

a search working identified firm will of candidates qualified highly and very number are the future. communicate executive our We near diligently our with in have decision and

January. we As on clinical the half laid meet pace are Precigen we year, latter a the pivotal head we you to out can entering the as milestones into of see, in phase at

for our be announcements our as to as call questions. platform. upcoming conferences, you updates excited providing now open are well scientific and may Operator, clinical pipeline and We R&D line at update the technology preclinical around

Operator

Instructions] our question And from appears proceed. Nick it Wells Please of comes first [Operator Fargo. Abbott

Nick Abbott

of questions. on team, for much first our amazing very and you half progress Helen the Thank congratulations for the year. taking

update? XXXX, the In as I And be of initial to so, would at to data you have get follow-up we Thank at what a X might presenting R&D terms well. meeting? expect want November you. And that then quick if

Helen Sabzevari

a And program Definitely, thank XXXX the Nick. gone speaking I as you, is rapidly. have that, you extremely to question. It's great for mentioned,

the your be and excited R&D investigator for forward And we very is looking data. day, are program answer presentation data to providing we We about the and the are the and by possibility of our absolutely, question to patients. at this the will

As covering I but a we are part of outputs the data, reason about number and be data tolerability, some we R&D, our the very programs, will and on program obviously, of this day which on and various is including Phase patients. this XXXX also R&D that safety the observations excited speaking because to of is showing, of

Nick Abbott

So in you your be need try surgery words on Helen, not might XXXX? for to and put commenting but after mouth,

Helen Sabzevari

that as patients. Allen results as what are definitely not the outline we provide the I'm going we will the more and well speaking on mechanisms, So will Dr. much of the color on Clint basically be but to ongoing about, say seeing exactly XXXX

Nick Abbott

if then ActoBio treatment. Okay. clinical Or I Terrific. this was and what for are it on result your committing plan? to now trial a goals of on you're And just trial. a potential this AGXXX, I licensees this all feedback partners? - can thoughts that or just missed the you term outline longer is program doing And maybe see the apologize was this I from and Is that.

Helen Sabzevari

definitely, So of capsules, is very we of but results. weeks it clear really IIa, almost promising. just after was combination from was was the a the therapy very taking showed and therefore, the Phase And seeing the treatment, with this monotherapy Obviously, I, AGXXX the became AGXXX of similar that actually good, orally data one itself by quite Ib very exciting. eight just monotherapy, which cycle with

we only patients authorities. that and of into this, obviously, treatment need Since these this this believe forward program now to have because weeks, looking And we safety with ways basically good, we we forward, for profile this As treated can especially this the discussion treatment obviously, we monotherapy extended. move authorities mentioned, the we is a a move very extend discussion they with AGXXX, that regulatory arm in the basically our with as fast of for have forward. patients in are eight program the was which rapid regulatory also in can look again, to And arena. discuss of are

Nick Abbott

thanks. And Great, congrats again.

Helen Sabzevari

Thank you very Nick. much,

Operator

proceed. Butler Jason JMP Securities. question next Our of Jason, from comes please

Helen Sabzevari

Jason. Hi,

Jason Butler

give you I with Thanks the we'll updates. level the which XXXX? event appreciate Obviously, data. versus questions. question. And which high granularity would Helen. XXXX expect details more give But other I Hi, I us R&D give medical be taking have the the you question for any And starting all of guess get you any to on a Can programs? just at can a at on for those data meetings. programs data from us

Helen Sabzevari

Sure.

we congresses, that the be we can will the discussing of reasons the with highlights have basically of goals of of one platforms our as imagine, is, for of is we course, highlights on and have some mentioned XXXX. the been already to the our the in all - coinciding and basically be Of for date you R&D going some giving

become be more are releases And and coincide especially we congresses - interim is that of and mature we have for data, time. And to the will the this the has with the early the giving So November guidance timing covered some data follow-ups, patients. allows we clinical the obviously, provide that us the given on data. at abstract and will that

Jason Butler

versus cancer, here? for unmet you the talk about monotherapy you're some dosing those need an then maybe can And you determining [ph] approval? path Thanks. little squamous dose? of about a Great. thinking PRGN-XXXX, Okay. cell just And be then factors in speak the of maybe just forward bit how example, can to combination went one And then for And path volume that was to expedited could factors? given

Helen Sabzevari

Sure.

So PRGN-XXXX, in extremely mentioned, program the has to as - this regard we moved rapidly. was

up Phase have We preparation observed in as was design the DLT. that volumes mechanism finished at the the I and dosing. volume But was that easy a the given. the which if highest applicable And see originally can as which we dosing doses, as we date can you about to enhance we of have go see, have have be a DLTs perspective a that that upon was not able we which, to we mentioned any seen to be higher in Phase action really any thought have first XX here already be we the redosing, been mainly seen about the obviously call, have The As II. dose. would is of keep part on do seen the were really redosing well the not - not T to cells safety we will There which data, DLT, reported, patients. that. we And to about presented we just we primary are because concept as CMC necessarily level we our looking have

you see and versus give have So it. have that received other of the that you they And platform patients power received surpassing them that currently some Adenovectors can the AdenoVerse only can we XX the multiple once. times

correct this, are In really we are in the path absolutely to the forward combination. for excited. So regard you

anticipating discussing tracking address and say, the AdenoVerse in are with a pathways there patients, off-the-shelf, specifically fast instance, regulatory no combination. various a in indications, cancer, of should patients As for for the of path FDA these is I - to the the we power cervical with path are you that. we and know, we in recognize forward, really forward And lot treatment this for with

- if I apologize of question. and your part So forgot I

Jason Butler

to Very Thanks. looking great. day. Thanks, was the That forward Helen. No, R&D that helpful. absolutely. was And

Helen Sabzevari

you. Thank Absolutely.

Operator

Stifel. go ahead. have Please we up, Next Burnett of Ben

Helen Sabzevari

Ben. Hi,

Ben Burnett

wanted here questions. up taking like like about would to bit the you you you daily around talked that? discussion some had data of for bar I have are of that actually follow you CAR-T one the It are you? little feels around the But be marker on but of data your away frequent? an for AGXXX, just the How I question What to more Thank a much schedule very and dosing, then would Hey. imply longer the earlier supportive our on another for AGXXX, assess get something might programs. able dosing? term like that thoughts dosing

Helen Sabzevari

we we Definitely, of continuous the support the with Ben. Absolute how dosing, based of have excellent we cycles and more as dosing we increase perhaps are that monotherapy, have safety we action, and this also we both the the the FDA and data discussing that. do exactly question, and - that the can more can mechanistic on is - and expand dosing mechanism a seen safety and what

So the in the the go, cycle, showed stabilization, was down, especially capital. exactly data eight want by one overall that basically correct going you're giving way of with that saw just weeks of that, you which this the C inhibition only the absolutely T is T saw. we we but not to we peptide Even with that autoreactive cells. these is what And cells the

can continuous we So more expand this to definitely dosing.

Ben Burnett

how we what will degree, study. that I this that I Very we terms - response? might just long something transplant just just the of on expect the in like physicians durability in to most enrolled UltraCAR-T ago a of achieving a patients could guess, this do mean on data And and cohort we likewise in about AML I'm learn were was at PRGN-XXXX to should think you and about assuming the follow-up might update. CR some that good we expect I what Or Okay. X, at seek the this of a that, to some durability But guess update? expect in handled way then first after in next this of depend learn question terms study. get given AML how interesting. kind

Helen Sabzevari

Okay.

with what of continue also quite be R&D. activity, way, day. address be the preliminary will And me the view in scientific the highlights we and and seeing just kinetic between on giving lifted also exciting lymphodepletion what definitely, let and the, we the being we the should we on the have obviously, durability, will are giving and non-lymphodepletion, is first, reported, reporting be that with What would the So by more presentations expect that on especially we our as coincides that, which is those. embargo clinical we the

really that seen CRI, receive the and exact well. have has becomes would to the this had a that this what what understand is, the activity. think patient under never is patient at normal we expansion yes, the as received normal clinical circumstances. achieved And I to dose regard and a a In transplant, with important also chance very transplant have the complete the the to gone transplant answer patient response, now

that of with patients they just so mind, we might that And we and other options information that are might options. as some be be can that also follow-up one will gathering transplant option. more these on But the have at in then one and be look treated, of been ongoing,

Ben Burnett

understood. Okay,

the to Thank forward Looking you. data.

Operator

Our comes Swayampakula Please Wainwright. go next Ramakanth from ahead. H.C. of question

Helen Sabzevari

RK. Hi,

Swayampakula Ramakanth

Thank How Hi. you doing, are you. Helen?

Helen Sabzevari

Good.

Swayampakula Ramakanth

interesting progress and far for a thought. certainly looking of number so Obviously,

ovarian Just a resistance question at you're looking on platinum-resistant - cancer. PRGN-XXXX, quick platinum

you there As for in the molecules population. are few play specific know, a

what also now quickly - the to to XXXX. do Phase move think you And earliest? you just the show II So and how so to trying and market it to about you at get need can try what to see that

Helen Sabzevari

Yeah.

in therapy, patient, We, instance, opposed this in a line. and as front are this treatments, the much forward this, And obviously, I getting the, looking is the generating patients and obviously, for very number what And have doctor, having that that the and very point soon we can is that II expansion have - to effect on we is you to up. persistent our front waiting the is as both evaluate data did the intention move which this rapidly cell our regulatory the at will activity. a are intraperitoneal patients. the especially that clinical I, mounting more even we but said Where objective all the be the dosing these front with this IV, very, it as level level every number One safety immediately remember, line the can is move our the well that, we know, point is to refers in adjuvant and and a aspect treatment we setting. faster two to to newest ovarian that scale [ph] which the coming, extremely for obviously, gene to are the power line setting, always I standing interesting of you we in To by of tolerability, safety the designs low. is to a and to Phase this of any and are PRGN-XXXX, Phase can kinetics of we of comparison X the groups. the to as also the the discussion and the population, patient move obviously the as - point dose immuno-oncology, the has for investigator the can allowed we So at the not this currently even cancer, the to this concurrently going dose as as IV for this have possible intraperitoneal, and you becomes Phase on the And imagine, and to of out that arm looking tolerability us raised, obvious is important UltraPorator, doing therapies especially and rates to stage Because X of Ib. difficult the as activity responses X. have with very our very of clinical much only think still also

So And are sure, patients faster, and they are our rapidly. in receiving the as be which are that moving and diagnosed is analyzing versus go arm those our been and we this made [indiscernible] be and the from for for phases would So the they we data And the have the for basically intention. the treatment that decisions receiving will that much - this. especially expansion IP then IV will treatment

Swayampakula Ramakanth

I you step in line. later. with Perfect. for back that. the Thank call going you to up am And

Helen Sabzevari

Operator question ahead. [Operator go Riley. Instructions] Next Sure. Justin from Walsh coming Please is B. from

Helen Sabzevari

Hi, Justin.

Justin Walsh

very qualitative for you you PRGN-XXXX the dose us you rapid taking questions. Or maybe so have is you That very DLT? Thanks did rapidly did enrollment? Can quickly a of was? hit a sense escalation well Hi. give the tolerated how complete because

Helen Sabzevari

- safety have add rapidly or you to safety very actually, per or to you as adverse of And good phase, expansion handled, the six I some XXXX, was we safety very DLTs the the and enrolled need hit very more the I'm We didn't of No. at we we course, profile in DLT. of and not three this events the with was patients plus the have away good giving same it in each six patients you And in know, go that three three three of there six dose. there to the as case are to part we are call. enrollment, per rapid token, that have our to profile a dose. it's -- now usually, for a audience, and had have to We back. go obviously, mentioned And

Justin Walsh

interested to glad you or looking you're give a commentary profile there give something just any Are away. right give on that actively ongoing assets Maybe you additional a us it. have? if acquire indication more Got drug I'll is got high so, I'm now? specific you you BD efforts little a I you in? And one on level. could to

Helen Sabzevari

to portfolio really very and manage our taking strategically of very of at coming this own rapidly also forward not portfolio, we focusing are our the are the we this year. and portfolio. very, focus think our only that's it move to but on point, focused And for our I we next how from level perspective year clinics, for this

Justin Walsh

you the Thank questions. for taking it. Got

Helen Sabzevari

Next [Operator Sure. Instructions] Thank Please much, Joseph Justin. is question going from come you Eric very JPMorgan. to Operator ahead. from go

Helen Sabzevari

Hi, Eric.

Eric Joseph

Hi, taking question. Thanks for evening. good the

secondly, towards further Or curious to this it at Just regimen that the data like development pivotal. that control on can at of that correct? you're as a forward and recently the reported it AGXXX. further? Phase should I evaluate then we sounds to you'd talk get measure? combination be forward looking Is couple you glycemic And a about, EASD? whether And guess, there you relates a is that potentially the something to on, extent contemplating that point, want is path track to a you Ib/IIa of stabilization sense AXc I'm that to monotherapy or

Helen Sabzevari

Yes. Thanks, Great Eric. question.

our we we on - data is of that monotherapy. only It's a months, after to increasing mechanism for the regulatory very saw definitely, autoreactive T actions forward treatment. And the stabilization of reason that T reduction only it And C-peptide, are pushing the of weeks autoreactive. we of basically eight treatment. cells, cycle saw with based inhibit limited of in regard not in So cells follow-up a the XX the for our

we preclinically, So that molecule IIa, basically, in to of is encouraging. as And knowing our that able periods of very Phase seen of allows results or the to I be more clearly, now longer had which move and we to saw presented profile safety us parallel dosing was Phase dosing.

expansion because considering that course, that In one was and obviously of [ph]. advancements. also there also is we of the follow So we've synergistic we showed that regard combination, is that will a to a are arm part and

we So excited we both, that, monotherapy. about we in for general, but we can see us, helpful. But also would very very our follow was are - basically, that

there patients. which biomarker very that reported, TXD the this - the is was another is was, as is was aspect in important HbAXc we Another stabilized,

we that, collectively, a you when our good So all with that monotherapy. put path we decided of have

with it's have at just the in As hospital, way, whereas very the that still mechanisms with to treat antibody it you immunosuppression, is home, associated you event days. take the a of this easily and AGXXX, good and with with the know, other they capsules with by this action. profile. the treatments, safety XX patients for treatment, It's allows use And very

this [ph] moving AGXXX is and So for how have those we we reasons, with are prioritized,

Eric Joseph

for great. Okay, Thanks taking the question.

Helen Sabzevari

you. course. Of Thank

Operator

this session. I like Helen for question-and-answer Ms. to the our back now Sabzevari concludes turn This to closing time, any conference At remarks. would

Helen Sabzevari

everyone We questions. and and listen call upcoming and providing to you stay operator. forward I and taking for the scientific updates look investor to thoughtful wish conferences. Thank you, safe. at to for Thank R&D to our healthy Day the time

Operator

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

now disconnect. may You

Precigen (PGEN) 10 Aug 212021 Q2 Earnings call transcript