CBMG - Earnings call transcript Q3 2019 | Cellular Biomedicine Group, Inc.

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Operator

Thank you for standing by. This is the conference operator. Welcome to the Cellular Biomedicine Group’s Third Quarter 2019 Results Conference Call.

As a reminder, all participants are in listen-only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. now Head turn Relations. of would to conference I Li, Derrick Strategy Instructions] like the to over [Operator and Investor go ahead. Please

Derrick Li

this Good for you thank afternoon. us afternoon to and joining everyone

margin, of Tony and Speaking operating you’ll is Officer Biomedicine completes open during other we Chief quarterly future Officer the regarding questions. Liu. today our forward-looking that consist statements Chief hear call some he After will of to Executive those of Financial and Cellular update, including will information his expenses, the revenue, Group, and today Please gross expenses, income allocation taxes, limitation, without discussion capital outlook. business note

Actual results our from could forecast. materially or trends differ

periodic please For and refer Biomedicine assumes of XX-Q. information XX-K to Group more Cellular recently date. Form as speak in or obligations their forward-looking information, statements filed respective any on to reports which update no factors Form risk discussed the CBMG’s most

for the I’d now turn to like to call introductory remarks. Tony over

Tony Liu

Derrick, new you, and corporate was Company major clinical facility development for everyone the and research US us for both our Rockville, We October foot a on and joining Thank made started in exciting to quarter commitment in XXXX. an a side. today. XX,XXX expansion our This square thank you and in clinical for Maryland

in use Rockville indications to United the our hematological site the in States. plan clinical We to initially development support

process, our clinical vein-to-vein trials. recall, operations the we delivery hone [ph] out develop CMC process institutionalize build investigator confidence budding you for As leverage initiated China high and our manufacturing and via swift, quality, to

endeavors. great are development for about trial US ready, are commitment us as site. marks While clinical sites a technology we milestone we platforms site those to beginning this clinical our Rockville add clinical This in excited we will believe

to-date. I proud progress team’s am of our very

presenting two team upcoming R&D be will this conferences quarter. Our medical at

of the this the is title CAR presentation or Adoptive Universal in Meeting Next Generation Immunotherapy X:XX Society at AM Presentation of up the of Friday. First Off-The-Shelf Maryland Cancer Poster at for a The Annual SITC Immunotherapy. is

American the Developing of at Orlando, or Novel AM be Florida. Center. as Additionally, Refractory known ASH titled Relapsed Anti-BCMA X presentation Society at CAR the the on Meeting presented Annual Hematology would Myeloma December a Multiple we at X:XX County Orange will in T for or present The Convention

lead of myeloma, terms for the in step clinical want of expectations We and asset, additional two Speaking clinical begin year progress. development IO in anti-BCMA enrollment multiple program sites your patient of recently. I this added January to

our in it can process market, and that ahead peers Although appear may slower that can been has seen help BCMA Having in in one we to BCMA key manufacturing a remain distinguishable shown companies our institutionalize by crowded we others of prioritize cautiously some early of I be work to INDs repeatable optimistic data. than are approach ensure that us, feedback, the quality clinical of indication. this our and obtain us is clinical

feedback progress. update Our still and early our intention clinical some to year to continue to clinical later everyone is this show on

great $XX.X June progress make first same for on cash three as at the Besides $XX our CAR, XX, which CDXX $XX million of CDXX to $XX.X the with compared anti-BCMA include sheet in end September our We we used XXXX. for quarters the in activities KOA. million and the IO million million in balance to of period was Net compared our operating to and for XXXX. cash XXXX clinical multiple asset myeloma, other ended for leading quarter continue programs TIL

see, and can been you on vision being cell of our our focused has therapy As executing integrated team vertically dedicated Company.

business will along close, as These XXXX China and funding in facility clinical with the we pipeline in US both programs in comes we and for to next XX upcoming Company the to additional of need to XX months, develop our will expansion clinical foreseeable develop continue capital and our future. expand clinical US. over $XX raise to our next expanding in to months and terms expenditures. operation significant use to the We to see our and Therefore, a require programs capital the our approximately capacity in terms continue US million of We plan conservatively to infrastructure.

on capable developing on a Biomedicine efficiency, cell continued own Group Cellular and therapy innovative our robust our stay a business. pipelines to focused scale and capabilities while vision out leading manufacturing has operation platform our side globally clinical to on Overall, building progress build We of to researching, both our of build as Company continuing the global approach.

turn back may Derrick, our I’ll have for that, any it discussion you us. for opening to With questions

Derrick Li

introductory for Tony the you, Thank remarks.

at this to like up questions. we open some So would time,

in the operator, we the person go So with the queue list. first order, on

Operator

certainly. you, Thank

We will of Kumar Baird. Madhu now [Operator The caller begin Instructions] R.W. the go question-and-answer first from is session. Please ahead.

Madhu Kumar

taking questions. for Thanks our

the something. for as So estimate of as presentation you and December well. and at try kind that expect a a but What obviously, first then reasonable close is one, BCMA be of will is number in might in a reasonable for mean, abstract the say expect three, I hopefully, patients I follow-up number you’ll have update I’ll ASH, to

Tony Liu

the Hi, Tony. Madhu, This how for you? are is question. Thanks

we months was to when our and patient. of that a and continue couple follow monitor with back think, submitted I we presentation, ASH

a at looking the are single of we patients. number think I So,

two do it. escalation. added to two about We sites. I last We that more And continued so far feel have months, good think we dose very

up will number pick you speed us be of to patients So, in terms of to continue enrolled. see

close total actual numbers, on clinical would I think plus Although, XX some the presentation. you yet, the expect dosed results fully efficacy, patients. share The with have safety, when not be to we ASH the outcome available we’ll may evaluate of ready about patients patients of to a you from do to the in terms but that

Derrick Li

additionally, Derrick Li. Tony. is to add that, I’ll And This

who with kind basically watching data story approach our that be conservative and that make sure showcasing. is we how our and we’re stakeholders So are on investors of to the to speak analysts to want we very

our is that way think has have to some some from accept that that. reluctance been goal to there and of pushback and who regarding and investors going be are in there a data really questions our reduced data showcase originating China I

our in so, to going is to the way that. to do be order conservative show approach most And

way the want that that’s Yeah. it so, to do And we going forward.

Tony Liu

Thank you.

Madhu Kumar

Hey, thanks, Derrick and Tony.

the beyond CDXX you program DLBCL. So and clinical might initial that, expect CAR-T post had anti-CDXX CDXX results the we program? from When

Tony Liu

question. Great

Again and dosed the patients to CDXX CDXX we have about IIT with patients in at is as We feel patients. clinical is, study treating so our good relapsed point this been positioned it. far, is

time I in see hopefully want which the that at we ahead great, we’ll from some weeks hopefully, So we in they efficacy indication but we, to think dosed have this point or see, early the early see patient, from the that perspective. perspective, ahead, weeks’ to with safety

Madhu Kumar

you then been immediately trial non-small PD-X Okay. direction say thinking you to of program? when TIL TIL, trial? right? the envisioning approach your kind make How are cancer And TILs, on has treat then program? cell Which are take progression tumor, banked you investigator-initiated have lung the Do inhibitor, TIL non-small So the anything was you or the about from Iovance for you bank previously TIL administer PD-X, the think approach with treat cell Moffitt approach which more about cancer. it your of the TIL lung about

Tony Liu

we lung an TIL considered you what we a going expansion shorten this are question, done, once One big then, picture, the we we then the consistent call approaches. time have the another cohort what be look and we biomarker scalable TIL however, call is based two that’s to method. process And TIL. point traditional method, program and methodology. doing a indication the cancer, the are the in collaboration would just method be traditional will in new less what with essentially at perspective second would NIH, to more yes. of Hopefully We, be at start And with through through or from expanding great TIL by to try using treatment process in we’re that are developing we a - our

on we based great [indiscernible] the consistent, to approach proprietary, potential methodology want Tier the lot results. well perspective, to it focus to follow historically from - in around perspective, to in solve call that’s caution treatment scalable traditional selection kind issues approach. case. We in of continue want that. develop why of manufacturing from the has perspective terms [ph] you programs the any our been, selection. clinical new well own as a working the energy sure have That’s early from of approach X strong biomarker long-term the we So based both of the indications CBMG consistently our this overall And from very ahead and as want the based We the been make has outcome, the TIL, but least, approach, from and we from saw at

more that’s the So in second, vertical. future it’s the when

Madhu Kumar

one guys I’ll in. BLA and more squeeze Kymriah you on updates China? submission Okay in the have Do any

Tony Liu

the We again, one, on thanks question. that for

with We Novartis work on that. continue

We’re making progress planned. as

So it’s track. far, on

pleased both with our forward for that. progress and we’re So it follow CBMG has with - filed Novartis. been good. CBMG, to Novartis, to both the you has with far frame specific but with accepted, Novartis collaboration deferred been continue pleased the and China our up so in IND move so is we sides, And time extremely with to We’ve

Madhu Kumar

you. Thank great. Okay,

Tony Liu

you. Thank

Operator

go Murphy ahead. with next Please The question is Amanda from BTIG.

Amanda Murphy

Thanks.

those a questions couple guess asked I couple So, follow-ups on to of of start to things. A some just off. of

the us pretty or in you’re of adverse ASH? IIT more front are specifically, being manufacturing is So that you your event can you you And even then favorable [indiscernible] could trial, on timelines, sense disclose secondly, or might why like, terms there seems it speak now seeing a is that time? in so of curious you profile to - maybe what sort give at just what if

Derrick Li

if mean, I know, can. I don’t we

Tony Liu

Hi, Amanda.

Derrick Li

additional disclosed ASH. I we to about data would speak prefer the that much not too at

etcetera. I it we Chief peers stated just we pretty there compared So of violate stated we ahead Tony Scientific [indiscernible] our conference. vein-to-vein this. kind believe Officer do But our believe the to that it on don’t manufacturing substantial that of have jump some just want to of to We any on side, advantages and that your because manufacturing at kind on

And end ASH, conference, should the so at and we up effort but pretty what be that disclosing we believe combined compelling. the

Tony Liu

How are Amanda. you? Hi thanks, Derrick. Great,

Amanda Murphy

the Chinese previously, What’s BCMA just on planning relates us? kind from a running. you’ve to IIT said FDA there? a next Then forgot obviously the got Are can step of update program perspective? us what a just the trial you Or - timeline NMPA? it on filing I but as there you’ve you because give

Tony Liu

BCMA sure, Yeah, first said the echo question to overall Derrick program. about want earlier sure. I what Great and

the sure and quality comes and enrollment make Our in. quality, enormous truly has with criteria effort every worked it every met enrollment, of closely approach on is single but has dosed patient focused the clinical thoroughly, Review been on hospitals. patients, and

So of process then that’s - great the are top very and that far by based on what that’s we digital swift proud from the our and review. in with of manufacturing,

We have the place. of best process in one

that under asset with filing Then the is way. foundation, IND

IND the manufacturing in to consistent we solve the will and the show later. perspective research in IND, from the decide case IND to the we we eventual may manufacturer IIT will I commercialization process versus all that the think regulators well both as which indications - of that and the not start peers, have place have CBMG as with then that be once That’s great show some follow CBMG. from perspective we that and

if line we change to you can IND the place that we sure don’t make all have process up stage each to dots, a manufacturing will, in and consistent we want protocol. to and show from we the where from we commercialization, IIT So

would as make much So that’s the approach working NMPA filed with and soon to we as process that’s the the and and very possible. in CFDA’s in IND sure

Amanda Murphy

on OK. to I Got as of then, question sort relates thoughts a partnership. it it, broader And guess, your

BeiGene been You’ve about at example. NCI at TILs, it asked with obviously recent Amgen you in bringing least NCI, talked for but the and licensing - some with there’s looking investments

obviously guess now I of you are pipeline part business in that So of broadly, I how you’ve a thinking be terms the pretty deep got it just BCMA guess, whether more curious, candidates. or just, about

So it’d be are thinking partnership, bringing how manufacturing the about drugs or you to US commercially. US whether the

Tony Liu

question. great a That’s sure. Sure,

cell CBMG stick to overall pipeline that approach which tumor we to want been consistently think strong therapy liquid a development have the we be a from you to as tumor. in only can see, I the not broad drug solid has

Kymriah bring to Novartis with partnership the have You China. to

We Universal have talked we about CAR. Earlier BCMA. the presentation

also have perspective. CDXX the the bi-CAR investigator-initiated We CDXX, from study

relapse We and have we TCR TIL for CDXX treating patients program. and have CDXX

INDs, have two stem and in and, approved far the China our addition both half has with the reminder that we of And perspective program in X four, from assets and the Phase by in manufacturing KOA have Phase but of capabilities that which just along strong also cell regenerative out a China we CBMG for the II.

we have the very and as the hand. yes, in others assets excited it a as on saw sector, capabilities. the So With overall, puts to position strong manufacturing the that, from our development this a as only pipeline well we from CBMG broad in the sector and both biotech with partnership leveraging perspective unique are

United profile, to the our So, we inbound-outbound great we move strong early come opportunities capabilities China, work and to the see us see partners us in safety with lead try others have or regions. potential, our manufacturing a it’s then development with States other and for leveraging work partnership both who out to only potential capabilities, with efficacy if programs,

open consumers see remain as we from will and there. it opportunities so, for go And we’ll

Amanda Murphy

given one but competitive And have not? how each in this point. just breadth and players terms many manufacturing is just to going you especially your like, I’m curious of at think for how quite answer that - about been that I’ve again, therapy up as asset you’d free a Obviously, shaping more cell there competitive pipeline it potentially I landscape capabilities feel are, have the there of you or to how just GMP and capacity. partnering China how players this of going however curious guess, forward back lot is the in

Tony Liu

a great Amanda. question, That’s

for known in probably and mainly China IND. then phase studies, think the clinical the IIT many of I for

sector. in So they’re this winning

cancer, when one, will the has continue always from one But the to you who stage other be us programs, take only have of able if the but that - at to been has on quality management, about hold today, we perspective, For quality then eventually the but the great allow I capabilities, also to view the our two the that also to conquer that for it’s three certain from will, point, with to or view years hand eye not work perspective commercialized on step. ready be keep it’s has on going about it great position we to system, [indiscernible] take from assets commercialize, each the strong that only be look an a also continue safety clinical and to to at say, because companies are they not now will to the CBMG manufacturing efficacy, next clinical is, the to whatever to a manual studies we in

back take to which And that with a in and us - certainly, ready manufacturing to from commercialization. great help able to research Novartis learned us couple working for our respect partnership we have tremendous the by site Novartis first deal in get our a now will from on working years the and we getting be to have actively

a the market competitive for perspective very So our position that the perspective. in CBMG view from all in from

this landscape. that very end, feel good within we positioning competitive from our about So

Amanda Murphy

it. very Appreciate and thanks Tony much Great, Derrick.

Tony Liu

Thank you.

Operator

is Cantor next Kumar ahead. Fitzgerald. The question with Varun go Please from

Varun Kumar

Hey, for good thanks questions. the evening, and taking everyone

the I three First at US again on lowest dose. the ASH program, a abstract, dose. In patients are the BCMA see still the collecting

I think million its X cells.

wondering already current activity dose the Just are the further seeing at rationale the what given of escalating lowest dose? is you

Tony Liu

we data, wait will the I think recent presentation. for ASH again at and from most clinical question, the Great least

from has follow then far, the clinical in there, the so think perspective. and which to from the I X low to mkg China that guidelines is from dose, CBMG mid overall been dose trying go

very cautiously we about that optimistic continued and on at ASH pleased from looking the so and December the the to present progress the forward to with are And additional very far, we sites, program are X. in early are we

Varun Kumar

heavily Thanks, on seven prior Great. treatment. line, Tony. treatment patient And of with I maybe the a think a patient it’s prior around and line pre-treated

the focus curious, expanding next I to different earlier - envisioning competitor the start then financing patient enroll enroll it’s line. than will myeloma in heavily line plan the of least you this trial, pre-treated earlier multiple or say, have very was year, Now, near-term have or local just meeting current you let’s the you are at you large patients? you to once

Tony Liu

again. question great It’s

a China available sectors, treating priority. start as that the as treat a US why segments have little myeloma the enroll to quality patients of we from challenge consisting multiple comparable the in and enrolling patients that’s position some enroll patients. the I and think and from different think terms drugs in in US I key perspective patients. our that passes, general US of of in Then, line bit a It’s time in as to more to approach, taken

we clear these been clear ensure about of enroll but for we long, and high treated and exhibited single before that has background has lines or forward work enroll, [indiscernible] very the been continue that would present the medical will ASH. well-known history, data ensured we’ll have comes to in, been be to terms do to physicians are and with and quality believe to look that we patients only we treating patients we what should overall, every and - the patients both hospitals treatment close that the the from with So in patient so the have the to extremely in then only try of

Varun Kumar Cantor Analyst Fitzgerald - -

time was Thank I And about the you the have you. may enrollment, ASH. follow-up for thinking on patient

a eight patients I at should XX saying or in some terms from bit to in setting January was of much and around color Now for you expect you what expectations ASH going may how mentioned? durability as follow-up investors, patients mostly curious, was have enrollment ASH, we mentioned, the Derrick study at maybe we just

Tony Liu

to the but patients specific I escalating defer of of ASH, have because studies this and of income really closely. number at percentage results, we follow and dose to terms In

and move next do to to you have and before the wait So the one stage to on than another dose. after committee then to review for

has by it time, step. So know, to take step as you

So bit dose think and efficacy although up more from we but to the high I we’ve in pick the safety from start perspective sites that’s now the to and just in then signal from then dose and a added for see meant be the the doses. speed low higher durability new the

sure perspective but become from So we keep to and posted early to as continue data it’s all and still duration the the response I’m will available. I therefore too think you guys tell,

Varun Kumar

question my and Thank carcinoma you, on the Tony hepatocellular last AFP maybe program.

If briefly of on the we the you some have can current just in terms enrollment provide next track what’s proof status year? are to of concept and data clinical initial

Tony Liu

know, only We you are of the about is as program, liver in those. subtype, AFP process cancer the a program, which patients targets amongst our of, Chinese XX%

soon have we we’ll process have to of but I’m one site in to - first So patient. you only the do have the of confident to and get lots tests that,

also as We’re IIT year, sure, see sites enrollment, back process, therefore, I’m to patients starting we’ll in next from far perspective. from the more two the and reporting you some. adding as And the

Varun Kumar

much Thank and right. Have Thank day. you. very nice a Tony Derrick. you All

Tony Liu

Thank you.

Operator

The Please next question with is ahead. Research. from David Small Cap Zacks Bautz go

Tony Liu

Hi, David.

David Bautz

afternoon, Hey, good guys.

if going I were one-off at to new looking the of a up for this Q, normal just I’m curious is pretty considerably expenses or noticed that’s that jump the quarters? future quarter. be So R&D kind that

Tony Liu

and question observation. Great

a you of the hand, in programs, start in from to we the a as terms as CEO, development clinical means think that speed the that of on programs costs development, want way know and rapid pick I clinical to also as up terms think but see increase. that a in as you I the broad biotech,

And but come and more to our come that program, at the as to speed that hate of in programs. in I So the next the think in start I and this in. it, in spend only data CBMG I is phase more fact a say more it indication development programs look a from clinical accelerating way, see you you

continued So, updates also clinical results increase but more expect program see and in spending, you updates. more you should and clinical will

think together. go hand-in-hand I So, that

Derrick Li

I’ll as add to that, David, well.

understanding strategy that process and a programs dose that done and of in about utilizing and IIT and very our in of signs piece get efficacy our China BCMA we’ve big consistent so and think programs. the other our we’ve been is I safety of clinical early several about within to

we’re one of in the translating and facility groundwork the rest - the And that, why so, our to efficacy is Rockville additionally that the the up doing leverage opened laying proving serious we’re belief then signal some and of are proof-of-concept positive work there reasons then that more we world. of that in work in and the back and the

that seen cautiously we’ve I we’re in programs so, sign so about is think just optimistic And what within that far. the our and

So...

Tony Liu

comment. quick A more add I’ll correct. one thing. that’s Yeah,

from perspective, because come to once you’ve you and IIT R&D you’ve that of you China gives done US point already. confidence the when some you - in to decide to So, done greater doing IIT in that you take US, because

they You’ve in seen more But some you high which indications and the discuss perspective. avoid and as therefore to safety but maybe from kind of that’s you upfront lengthy say, any success. from expected, only then, the long bit not a guarantee - spend efficacy China the that to program program perspective; you efficiency don’t efficacy has

to chances, and it help risks you if does you will. provide However, better potential mitigate

David Bautz

you for you the that the And value needs upcoming call, sorry in Okay. please? your missed what I Earlier had that repeat what you so given could for year. I’m value a was, thought Yeah, cash

Tony Liu

$XX million. was It

David Bautz

Got it. All right.

Derrick Li

Thanks for the questions.

Tony Liu

expenses CapEx includes and the and operating Which et cetera. normal

the China covers US in infrastructure also programs both it well as So, and and expansion.

David Bautz

thanks. it, Got

Tony Liu

Thank you, guys.

Operator

today’s concludes session and This question-and-answer the conference call.

your for lines. pleasant participating and have Thank you a disconnect day. may You

Cellular Biomedicine (CBMG) 10 Nov 192019 Q3 Earnings call transcript