Bellicum Pharmaceuticals (BLCM) 12 Mar 202019 Q4 Earnings call transcript

Greetings, and welcome to the Bellicum Pharmaceuticals Fourth Quarter and Full Year 2019 Financial Results and Corporate Update Conference Call. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Mr. Stephen Jasper from Westwicke ICR. Please go ahead, sir.

you. Thank and joining everyone, call. you thank afternoon, the for Good Rick the President Atabak With Officer. on is Mokari, Fair, Financial and me today Officer; call Bellicum's Executive and Chief Chief will Aaron Head session, Q&A the available. during of Later, Research, also be Foster,

for this and fourth XXXX. full Earlier XX, quarter December the financial ended Bellicum released afternoon, results year

the to this the you list, can so on not If if would distribution you received have like the you Relations company's page of Investor or release to website. be added do

conference today's the Reform of our reminder, financial As filings, include under our approval XXXX, clinical will regarding review a statements made plans, of our regulatory outlook. product call Private forward-looking statements plans development Securities Act regarding candidates, research and and trials, commercialization Litigation and including expectations

involve publicly and undertake These of the opinions events. of a reflect our the risks or information or as We any this light to call. forward-looking number future revise and release of only to statements uncertainties of in date these of results new revision obligation forward-looking no statements

results year filed and indicated Commission. our forward-looking XX-K numerous the due to section XX, December discussed by including Securities Risk Form differ those those Actual statements factors, of in for these with the from the XXXX, ended may Factors Exchange

over I and call now And will Bellicum's turn to President Fair, Rick the CEO.

corporate provide announced Thanks, Stephen. recently on update an our I'll today. Good and GoCAR call, two afternoon, everyone, and our and us thanks for On platform programs joining transactions.

distinct a reminder, platform As in GoCAR differentiated ways. our is two

primarily coactivation MyDXX, more current CAR-T. efficacy to MC. GoCAR engineered generation our potent to with domain, accomplished and is we've the durable or deliver First, goal CDXX This relative through

tumor enhance resisting the proliferation believed exhaustion is signaling system. stimulate patients' to effector suppressive cell to persistence by survival and cancer immune to the functional own and MC and microenvironment boost

the their of providing antitumor by performance, higher are effects for unpredictably scheduled to controlled due administration technology. rimiducid. therapies our GoCAR switch control enhanced activity, engineered we've but autonomous Other CAR with behave Second, GoCAR

modulated incorporating by product rapidly be rimiducid they acute can by In which activity our interval we triggered cells CaspaCIDe eliminate between manage is to our to doses. switch, adjusting GoCAR controllability occur. the toxicities if candidates, safety improved when dual-switch further designed

As platform, in these GoCAR shortcomings may preclinical benefits the cell work in therapies. the some current of many CAR demonstrated address of the We've clinic. we of potential observing evidence now and believe effects these next-generation of our supportive are

currently are strategic two for platform. pursuing GoCAR We paths our

generation while may Our benefit is current CAR-T first little tumors signaling strategy target have MC to activity. and solid offered where therapies enhance

BPX-XXX HERX. PSCA Our targeting GoCAR-T targeting solid and include BPX-XXX programs tumor

strategy critical second GoCAR We proliferation potential pursue off-the-shelf allogeneic and delivering with drive response, of best-in-class immune of a to newest which the and effective approach therapy. both is an demonstrate host which Our stimulate is cell believe platform program, to to our be our persistence a to therapies. off-the-shelf to that potential the seek targeting GoCAR-NK BCMA. We will cell has our

Now provide let our an update programs. each of on me

from patients. was schedule evaluate single an first I/II GoCAR-T Meeting during optimized trial. and Annual BPX-XXX data presented candidate, of intended not dose safety At was of for and in last cancer the we ongoing targets The pancreatic Our product PSCA to efficacy. June rimiducid escalation dose clinical year, ASCO Phase clinical

for were a schedule efficacy, or shrinkage between late-line treatment. and receiving XX patients suboptimal pancreatic stable with including the of disease, These tumor achieved X evaluable However, of patients X XX% patients cancer XX%, XX%.

encouraging. So these results are quite

support Cohort and GoCAR we this data of In presented platform that in highest the the BPX-XXX further potential January the solid tumors. XB of from new translational year, dose

CAR-T GoCAR-t X tumor cell consistent cells immunomodulation, in a mediated changes of with for the including We microenvironment, reported are encouraged to of up expression in by findings, many and productive infiltration, the months gene immune persistence response. tumor

evaluate to rimiducid XC We repeat now enrolling dosing. Cohort are

experience Our T clinical can cell suggests potential. dosing that maximizing exhaustion, without time cells the regular efficacy creating and expand GoCAR-T preclinical reactivate over rimiducid

complete are is time in this this We to used cohort as the system as eager patients first intended. is the being GoCAR

pancreatic proceeding second-line expectations. this and in patients line cancer with our is in now cohort is of Enrollment

results product We we are planning a seen meeting on at a we GoCAR platform. Based for the far, as about so end to BPX-XXX and optimistic of medical the the present as interim clinical year. data our proof-of-concept by have remain a candidate

which to safety me HERX. We observed to solid is cancer CAR-T target BPX-XXX. therapy tumors clinical validated in academic target dual-switch that BPX-XXX HERX has trials. shift because let candidate, program it selected as activity designed Now first Bellicum's a This is target for with for product express been reasonable a and

experiments to We technology efficacy improve FDA After suited driving safety the and BPX-XXX, these platform. an to may underway. upon providing data switch the greater The submitted our additional extra candidate. the product dual-switch application layer our by we efforts requested non-clinical to believe MC for of further IND generate additional uniquely through data an are characterize be via signaling earlier that non-clinical

third We in year. expect with quarter progress update the our to this provide of on BPX-XXX an

Turning off-the-shelf GoCAR-NK potential We're CAR-NK our therapy. wave our represent for BCMA GoCAR-NK candidate. cell the first cells of to next program. excited the evolution in an about exciting

activity NK important recognition, responses. possess to an in also cells addition immune play an role cytotoxic In and CAR-mediated antitumor antigen X

graft therefore, versus NK and cells transfer, causing for particularly following be host off-the-shelf propensity may adoptive disease allogeneic a therapy. cell Furthermore, useful have low for

safe, While NK largely vivo has modest due have with limited persistence. been to cell therapies been previous in efficacy expansion observed, and cell experiments only NK

We our survival MC enhanced in our proliferation, synergized preclinical of to cell function. the CAR, tumor-specific IL-XX In in at in resulted presented models. efficacy non-clinical NK enhance cytotoxic and Co-expression a SITC multiple studies, IL-XX, domain, of platform and meeting November coactivation in with vivo tumor data last year. GoCAR preclinical

that cell the as on serve selected off-the-shelf and initial have cells best-in-class GoCAR-NK our program. Based proof-of-concept target believe we potential BCMA the these we a studies, therapy, to as for

studies observed. CAR-T our multiple myeloma in rates response high well-validated autologous already BCMA with from is

the Given durability our may preclinical that response. GoCAR-NK experience, of we improve believe

therapy, cost an may that anticipate and Also convenience greater faster bring, we time manufacture. off-the-shelf certain treatment, advantages to to the and as scalability and including lower

benefits processes preclinical to prepare in scale activities proprietary We these cell deliver manufacturing. to initiated developing GoCAR-NK program. GoCAR-NK development are We BCMA for formal our recently large

to of year. present data this preclinical expect end additional the the We by from program

the development That me programs, summary our let turn concludes corporate now of to our updates.

year, First, acquire an asset facility regarding earlier for Anderson manufacturing Houston operations, $XX purchase we to this manufacturing with announced agreement million. MD our

substantially on strategic underutilized current our programs, facility cost focus a Given with the was base. GoCAR fixed significant early-stage our

to of supply, operating while Bellicum's end product us close future the costs. by transaction current we is As therapy reducing into to a transaction, expected manufacture MD also candidates. cell enter The Anderson product part the first our quarter. supply and transaction assures the access with will agreement of preferred to This

unrelated million plus late and its milestone MD XXXX, and separate a upfront option In future Bellicum's CaspaCIDe license for in we that payments royalties. a Anderson payment technology announced to $X safety transaction, exercised switch

The our use that license validates further covers interest to recently specifically agreement Takeda agreement Pharmaceuticals. Anderson's We with in sublicensed this and of Bellicum CAR-NK that safety cell believe CaspaCIDe the switch program molecular the platform. MD switch technology was CDXX in our demonstrates

like financials. over I'd hand our to to review With call that, Atabak the to

license full use fourth of quarter for Rick. for switch. XXXX. QX revenue XX, Bellicum from results the MD CaspaCIDe the year The included for of XXXX ended fee Anderson million reported you, $X.X the XXXX and $X December $X.X Thank the safety of million million a

and $XX.X $XX.X were XXXX, $XX.X expenses to year $XX.X periods fourth million for and respectively, R&D and during the million full the XXXX. comparable million compared quarter million in

rivo-cel, respective of compared the in the the in fourth to periods XXXX in implemented R&D and general salary-related The year reduction quarter half related employee expenses was primarily due to charges to force expenses that XXXX. second full the and reduction XXXX were in during from reduced

arising offset from These severance intangible the our and of impairment asset Supply employee the program by force. were Miltenyi increased recorded partially expenses from the the GoCAR-T in related expenses reduction reduced Agreement, costs to previously

administrative General comparable $X.X and and million the in million million $XX.X and expenses million fourth full were $XX.X respectively, to during quarter periods for XXXX, the $X.X compared year XXXX. and

due expenses XXXX. XXXX XXXX a was force primarily the in second and in period decrease reduction quarter during reduction the the The in of the implemented in compensation in to costs from that relative of share-based fourth personnel to half comparable was

The costs effects increase to to XXXX, activities the compared offset by partially an year a commercialization personnel activities for employee rivo-cel-related reduction half that of expenses primarily prior and salary-related due increase in was in in as reduction XXXX year full the commercialization in charges. during well of force G&A reduced the first as the

XXXX for the for $XX.X a million $XX.X $XX.X quarter full of the XXXX. $XXX.X the of fourth compared to loss year million net million in million and XXXX of net for and loss period a comparable reported Bellicum

warrant of full respectively. related million $XX.X results quarter The the million fair fourth expense of in included change year to in value and non-cash and the XXXX, $XX.X liability

Turning to sheet. the balance

and streamline quarter, cash cash cash XXXX, we included of quarters, and steps totaled fourth given $XX.X organization. taken a approximately license loss from we XX, decrease had operations the the fee Anderson December the cash equivalents and million. which $XX.X restricted million, a MD was from of prior In As the have to

Based assuming million of requirements to expects closes cash be cash the to resources as million operating Bellicum MD into $XX and XXXX. on utilization scheduled, half facility the current in second will and $XX operating XXXX plans of sufficient Anderson current that transaction meet sale

over back hand And to now the call I'll Rick.

Thanks, Atabak.

by of which accomplishments. and transition refocus XXXX, our us, year Looking pleased back at strategic was I'm a for

We program. progress our presented GoCAR-NK and and submitted for IND first an clinical BPX-XXX made prepared BPX-XXX, and on data initiated application

a our our reduction of us the extended of From our operating perspective, strategic into half a our priorities we fund corporate second our of safety switch, financing, in manufacturing XXXX. and sale runway which facility, enables cost license base to CaspaCIDe significant through

to by on GoCAR-NK third I This present the repeat clinical with BPX-XXX. program. we're the on end data IND BCMA In preclinical programs. progress rimiducid additional on planning dosing the update in we application to year, for update you for And quarter, our plan and of of our status the focus XXXX, BPX-XXX anticipate

updating excited of our our forward our I'm pipeline, on about look the I to you and GoCAR future, efforts. potential

the questions. call to open Operator? now I'll

Jefferies. Biren with first proceed Instructions] [Operator you. line Amin from the Please question. Thank your Your question comes of with

second Thanks Rick, from the questions. patients XC guys. in year? the taking the many the on my Hey, when we you of half cohort, should data us XXX, for expect give how

Sure.

and then a is X this X clear design cohort, treat patients X second it's DLT with a design. window the So window. to DLT designed treat additional plus the patients, In X

patients. total X So

on number time and patients on experience depend DLT. report on follow-up I think not patients any the or and also whether certainly we will that of depend will enrollment

So that's the patients. neighborhood of the number of

And present compare cell you And cohort. when patients saw compare it data you - to we with think, I saw when presented, in pretty you the a I and the that and that data X think XB when disease I you persistence. stable expansion decent,

do you get to where we persistence what you standpoint, So standpoint patient this I biology think need start guess, expansion and in from to a can population? from an to PRs see

Yes, space, don't in it's experience in of a cell lot of solid CAR-T We have cells tough unfortunately, answer, question to the tumors. driving a therapy responses Biren.

which little periphery. a the in that hard correlate it's So know with we're typically measuring how to to expansion,

I'd we that what those say these cells in is system reactivation with drive of important, persistence cells host a response. think cytokine that production both the and I and is system our that will believe engage proliferation immune of to drive to

patients will And we'll that pancreatic to will on Whether have just greater that cancer in not, our that, partial preclinical based responses achieve tumor lead experience we're optimistic see. control. to or

for opportunity? then into BCMA the was going rationale And what pursuing Okay. NK this

a the on discussed an NK for NK own I inability cells, It The limitations exciting as with the therapy. persist. call, cause and tumor. - kill cell cell historically, It GvHD. think doesn't is, lot off-the-shelf an have I platform ability for its has NK to an the by driven us, proliferate to been So

an off-the-shelf So it's challenging. therapeutic, that's

to We do system have that. that's a designed just

an So that's think of area have the the best-in-class, platform, autologous targeting to therapy, BCMA that. role our NK solution to the will experience. an in rationale And be think we for clearly cell CAR-T selected cell we we have differentiate the BCMA. preclinical because ability for based GoCAR-NK where an with off-the-shelf really ability there on findings based on important portion We the we be

validated it's say new cell evaluating a I when is that useful for have confidence, target would clearly, some level like of also technology ours you're therapy. target to and BCMA

Thanks my questions. for taking

Thanks, Biren.

Wells your question proceed the Abbott Please Your with next Nicholas line comes with from question. of Fargo.

for on for our James. Nick It's Thanks question. taking

off on just So starting maybe XXX. Rick,

that So these non-clinical studies What of FDA's can concerns? being have confidence undertaken? are what you address on you elaborate level will

Yes.

levels with So FDA of their express understand HERX, the experiments based healthy interaction on nature of we're the evaluate will that lower tissues conducting being specifically. BPX-XXX the believe our cells to information follow-up interactions of answer in requested, which level with of to questions vitro we

relatively But would what those level being to get we the Obviously, we on and I'd high need as say response. asked is say an them complete high. update, date. question their provide seen QX. is and confidence submit experiments our based to level indicated confidence We'll our and we've in I

long roughly, to how guess, we were you experiment, review. I mean, you these do complete take? And experiments assuming the they the agency, submit that I

time we been through that the QX, kind review of by So you've get to process?

vary. the think I Well, But we outcomes for have the to could and if certainly, looking that yield goes that's if conduct depends were it additional If don't design we our we the well, results on of right. all experiments. that initial experiments -- ones, and

that really answer questions. we're we think I can I on to right don't things to speculate other that much say the doing their think too So than

will that time. few questions, and answer I think have update in we months' their we optimism can a they you

then you're best-in-class you can a talk out for try about I that use? strategy there's What's you your biparatopic get, and binder? human hope going binder is some a there that's for is And fully binders. data what the to mean, the GoCAR-NK, Okay. binder

currently that. speculate our of is we're probably part Binder certainly working much finalization of design construct won't too We the on. on selection that

Our program for time for need in that anticipation candidate work that we final have little year's or less. selection we'll and a a is maybe about that what through

more think So as on we a we'll that I little and update closure I that. on do don't get you and currently, speculate experimentation

for this expect we IND program? then an in 'XX should And

it depend our - X I roughly we on where years estimate to sit think our but IND progress, obviously is think I will from our current today.

gets on that possible, But a potentially is into I late work. but could potentially also based you our in time So 'XX. early would change say X that lot 'XX years'

final back of - just in use one the I'll queue, cash. jump in then of terms me And for on and

You've program. clinical got one

a You're patients competing with perhaps handful being enrolled. of

And million So an what $XX into to is year? move or… is this assumption driving the that million cash utilization XXX of you clinic $XX the there

Atabak Yes, address I'll let that question.

Sure.

in Nick, therapy And talked and amount about fair associated it So we've we reduce of -- of fixed the as of ultimately, number expense costs. expense it. to cell a fair you has past, measures associated cost with a our a with amount taken

So reduce as we've as much tried possible. to that

that around around is assumed in of for - this what is So the expense. from and what's so year I in think we've terms clinic primarily BPX-XXX driving

Okay. you. Thank

Seedhouse question Your with with comes from your Please the of Raymond James. question. proceed Steve next line

The Good Thanks for afternoon. This with question is BPX-XXX. Daniel on is Steve. to for taking the question. respect

quick GI see following you be Do to Cohort dose? in by ASCO of BPX-XXX possibly adhesion. due your redistribution you to in cohort? we So from T repeat copy drop the just suggested this stream, exacerbated XC you expect that vascular do Or cells to with rimiducid expect number vector was that activated a potentially effect rebound in as XB be blood as infusion with poster, rimiducid

Research, Aaron over question that call. the to turn who Foster, on I'll Maybe is Head of

Yes, the thanks question. for

blood. following to the seen hypothesis number have as in as and number vector to a expectation As activity copy for XC T you've iMC-related well of types with our is, immediately activation. the suggested similar peripheral copy as in see margination respect you Cohort Probably, our rimiducid vector would decrease is we cell we is that this noted, of due through consistently

consistent activities be due of primarily effect activation exposure or periods preclinical persistence is be determined. in we've This rimiducid that that over to and expansion, ultimately studies of yet the number CAR what our to on that fact antitumor will observed a

great. question. right, All And another

have patients your be plans any may on, you week? you patients skipping a be dosing on impacts in going case reluctant And once come clinical appointments? rimiducid you pandemic repeat for -- contingency dosing some in those As coronavirus seen the mentioned, to you more trial? do have or do With will any

Yes.

would now, great see question. conducted. being screen of of continue trials to pandemic days in Obviously, patients our our as sites to U.S. are we're their the early clinical where ones. I So and continue in new the here say,

And currently. no really of so effect we have pandemic the experienced

a highly and evolving this characterize That said, very fluid would rapidly case. I as

We are necessary and try actions sites, with contact in are to new take on patients and that ones. we'll regular to continue are and to study our the whatever acquire treat

us their we're and patients need acute have been who an treatment. think to with refractory message I relapsed cancer has dealing pancreatic for

a And likely of so it's system. care more health continue care type patient get to I think that even be affected would in that the care would seek and profoundly

my taking for much very you question. Thank

comes of Your the with question next from Wangzhi proceed Ladenburg. question. with line Li your Please

of already taking for questions question. Thanks Hi. asked. Most my

Difficulty] So now. can you [Technical right patient

they to -- is one presenters? X in but X by -- across parallel patients, the a include multi as Or said one? You enrolled

Your I the more enrollment out of question. at there cell understand clarity current if Cohort of the the cut the XC there? that phone it's But the in correctly, on question beginning schema

many centers how Or sequentially? by X So patients? they X in enroll Do are you either enrolling parallel? patients

it. got Yes,

So we enrollment cohort sets. the X have X different of sequential

we So window. But then wait in in sites. for have to and wait enroll we parallel enroll for currently we X X We're then window, can parallel. and DLT other in open DLT can X

And XX days? the window safety Okay. is

you Wangzhi, I'm sorry, can repeat that?

window days? safety is The Sorry. XX

third to window I'm cells, then is dose the Yes, we or the post -- of the wait rimiducid have second month. a second third -- safety or from

XX-day patient cohort. in So period the practice, talking a in you're post patient the treated about roughly last X

it. Got

feedback? do provide data of you with before provide new you you update the Okay. And on to expect an FDA will an for of kind already the provide to then Do you FDA Or to the have quarter? in communicate update when ahead update? expect XXX, an third feedback their

from initial experiments submit and communication. the and and to answer if we question, them feedback be an committing FDA. of update That go set our well get positive will the provide the we're think I regardless,

think, sort a vitro we'll and describing in I don't to be question, that. our some answer experiments additional which in we experiments, of scenario, initial of in case, the needed round downside conduct

So I think there's a range of outcomes.

today we'll indefinite think on I update, but third to to we're that we're update next our committing is have not we'll here midyear in period an the going you. clear what be the quarter, to call

Got it.

question Okay. Atabak. a last financial is question The for

for shares shares. is X we closer look the fourth outstanding if number million to at So quarter

reverse is think split. I because the that

As in done this February far year. split as reverse is

the looks how So why number me - is for -- quarter had the the help understand split shares already effect? like fourth reverse

the you you presented split you complete For XX-K, retroactively. -- before file if guidance, the your you reverse accounting

got for Thanks it. question. Okay, taking my

next Fargo. from Wells Abbott question. Your question a follow-up with is your Nicholas proceed Please with

Hi. taking call. my Thanks for

appears So just year. -- XXX think before and your the CAR this I compared going And was highest when to in the figure it's tumor treatment, And back PSCA baseline. had poster at I'm XBX PSCA is presented the that of signal after one who number to highly the in looking expression diminished patient earlier untreatment cells. XXX the infiltrating

I sampling, going that, of So either the tumor. [indiscernible] you're see B, target A, guess down, killing means that that is you'll level that

staining this on address was able at other whether issue, samples trying were tumor to you tumor and cells? regulation do there look these So of or clearance to to it's down actual

Aaron. to question I'll to comment? Aaron, want turn over that you do

sure. Yes,

levels for more we the about, protein that, looking at probably appropriate, we're RNA hybridization to good that assess in So of course, protein in think for immunohistochemistry ongoing. through and currently used while the level you're is work way developing that probe measure assays figure situ to a we is talking that's PSCA. expression, PSCA And an

about whether very question agree would certainly the something not. I with that So more hit it's interested and the exploring protein levels expression or understand in to we've heterogeneity we're -- your target about comments

a back then going to cash And just follow-on utilization.

obviously, asset in use agreement structure? rivo-cel, on is any comment an there's rivo-cel? -- no statements. lack But interest And funds of this from contemplate lack so In cash prepared terms coming does financial on the the of asset, in your a of your in sale

we have the of interest rivo-cel. in Yes, I identified that think universe people have

to come for acceptable We that may are terms and we the not. haven't asset,

the we we rivo-cel assumes certainly guidelines related have costs retain asset rights that that amount in we'll ongoing current the the the to some on future, have cash concluded. an clinical monitoring provide if of trials update But and it. to Our

And with not a transaction we're transaction to strategic clear, be any that. -- occurs assuming -- a

our would to be So incremental cash that benefit utilization.

Okay, Thank very great. you much.

Mr. we question-and-answer gentlemen, to turn closing back and Rick Ladies end have for like the Fair session, the the remarks. of would and reached Okay. I call to

in participating intense and everyone, a day. today Thanks, busy for

As who day, always, this Bellicians, us, our team our afternoon. clinical of and joining our the feel have like free every inspire please and passionate ones who effort participate the if I'd additional and questions, to investigators, our in importantly, trials. contact They're you most to families us thank for collaborators and thanks patients

concludes This conference. today's

your disconnect You participation. Thank for this your lines time. you may at