Bellicum Pharmaceuticals (BLCM) 6 Aug 202020 Q2 Earnings call transcript

Greetings, and welcome to the Bellicum Pharmaceuticals 2Q 2020 Financial Results and Corporate Update Conference Call. [Operator Instructions].

As a reminder, this conference is being recorded. Thursday, August 6, 2020. I would now like to turn the conference over to Stephen Jasper from Westwicke. ahead. go Please

Aaron the released Mokari, Research, Bellicum will Head afternoon, call. during Good ended for results Rick thank for and you Bellicum's Thank me the everyone, today available. Later, and Foster, the this Atabak June Officer; Executive With and is X XXXX. Financial be months Earlier on of session, joining Q&A Officer. afternoon, financial also President second you. quarter Chief and Chief the Fair, call XX,

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

call ended Rick December now and XX, Bellicum's And the forward-looking will risks over plans, XXXX, release Exchange and Bellicum's approval As including opinions new candidates, regarding statements factors, of XXXX, undertakes year June Securities to the those made statements forward-looking outlook. revision review due by XXXX, including and statements Private financial clinical a the CEO. this call. regulatory publicly Bellicum's discussed filings, indicated Fair, to These commercialization these may the product no of Bellicum's will Act any differ its a XX-K those reflect results numerous call future Form involve the and ended under and in turn Bellicum obligation research in of and information Factors trials, of revise expectations only date uncertainties light reminder, regarding to today's forward-looking plans I of events. of or statements or from development President number results include XX-Q Securities with the statements of section conference Actual these the to of our the Litigation as for XX, and and Reform Risk for forward-looking filed quarter Commission.

our results. our everyone, GoCAR call us. afternoon, Atabak on update thanks today, I'll for and and an On financial on our joining provide you pipeline, Stephen. Thanks, Good update will

Before how from I cell programs, our me let differentiated therapy is remind approaches. you about other individual talk briefly GoCAR

platform ways. distinct Our in unique is X

engineered boost resisting we've therapies. to signaling suppressive system we this exhaustion can CDXX by proliferation tumor MC coactivation current cancer domain, believe and believe relative more the enhance persistence to primarily GoCAR potent First, to can or cell MC. stimulate and effector We through functional efficacy tumors. in survival, the cell own accomplish generation microenvironment patients' and durable our immune attack deliver MyDXX, We

higher offering can Second, performance believe interval activity we've GoCAR further dual-switch triggered therapies eliminate between improve via can safety address relative GoCAR therapies, toxicities of by the GoCAR rimiducid product dialed they many shortcomings if behave switch, CaspaCIDe molecular GoCAR would be rapidly rimiducid the but down generation administration. In We rimiducid. our for intermittent to platform adjusting by controllability current cells the due controlled anti-tumor by doses acute our or cell our administration technology. effects current activity, of to scheduled their potentially be up cell our cell to engineered switch or unpredictably can autonomous superior Other suspending we can manage therapies. when which occur. incorporating -- further of candidates, control may

effects are of observing now preclinical we in Our potential and clinic. demonstrated evidence investigations some the have benefits, these supportive these of

CAR-T hostile challenges of establish to efforts. confounded the are cell the that X strategic we paths clinical where signaling of T heterogeneous may help solid microenvironment, First, overcome pursuing concept: exhaustion proof have expression the tumors, of are tumor and MC We effects targeting previous antigen

and GoCAR-T candidates, targeting BPX-XXX, Our BPX-XXX or HERX. PSCA, X solid targeting -- tumor CAR-T

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

provide clinical activity, me these dose programs. cell to benefits antigen now of ongoing of prostate an platform Phase from the have data on shown targets update we GoCAR or biomarker that PSCA. encouraging have data BPX-XXX the in pancreatic hypothesized in stem solid an tumors. date safety, each Let trial escalation supports presented I/II The biologic cancer and

consistent encouraged infiltration, the persistence particularly CAR-T in a cell GoCAR-T microenvironment, response. X are immunomodulation, and tumor tumor we with gene for mediated by to Specifically, of up expression of cells productive immune in observations months changes

enrolling repeat of We Cohort dosing. evaluation are now rimiducid XC, our first-in-human

preclinical that the which the a clinical and enrollment, and of this present. results impact presence suggests time, at we of the and follow-up COVID-XX cohort creating will cells experienced end expand efficacy this rimiducid screening We thus, medical year. experience the in can for T over antigen reactivate the may duration others, cell GoCAR-T on regular meeting have plan maximize tumor of Like exhaustion patients number and Our related many to we without of by interim that dosing impact present potential.

in due addition, we some degree can to Cohort we assess XC, patients. collect date COVID-XX study at these to primarily been post-treatment In to sites, restrictions what limiting have our unable in biopsies to

study and these investigators will continue the the with We overcome prescreening few process to a activity. to sites extent possible, COVID-XX work in the to to adding are increase obstacles more our to of

to to believe protocol several submitted have FDA cancer this expand enable pancreatic more with will the study. the a to we Upon and ahead, prescreening. Looking eligibility which we of FDA to IRB we clearance third-line modifications amendment patients, amendment, plan

profile the kilogram. escalation cells dose to XX we've by will risk-benefit to extend date, million per informed observed we Second,

cancer. will add metastatic we refractory, Lastly, hormone with cohort of a patients castration-resistant prostate

to on BPX-XXX, and a our Assuming both later protocol Based seen data amendments, of begin prompt year. GoCAR product study amendment, we candidate remain about proof-of-concept platform. optimistic expect enrollment as the we've this FDA so as for under we clearance this this the amended far proposed and

kilogram believe CAR-T technology on first demonstrated plus cleared you Phase solid study designed providing our may by update trial is program efforts been for year. Bellicum's multiple later extra reasonable to that BPX-XXX, initiate trial HERX recently upon Phase X dual a II switch have we me safety. Academic HERX. dose through followed HERX-positive solid escalation that will trials escalation target in basket at will throughout of BPX-XXX The and targeting be and let receive patients product Patients I/II cells our enrolled per BPX-XXX This BPX-XXX. are in HERX-positive efficacy escalation. activity IND to which a followed standard XXX,XXX currently dual-switch begin suited cells. traditional in MC improve express candidate, has conditioning We start-up in signaling is The driving by earlier dose Dose Now and X of safety by these expansions Flu/Cy tumors will a clinical FDA tumors, be clinical layer our an platform. this uniquely greater cancers. and switch via to sequentially

dose-limiting in disease receive while to first in The weekly each will cohort or followed dose will treatment, patient either rimiducid be without cohort patients the toxicity each remaining progression. subsequent

progress. our study are to we'll posted We keep underway, this and on get you excited

cells our for Now therapy, work, on encouraging for and have well cell candidate. this platform cell enhance in next of causing GoCAR preclinical NK are published graft-versus-host with our cytotoxicity The let's disease. paper secreted that first meeting NK may presented XXXX SITC evolution program with represent an and NK a year be cytotoxic to from wave allogeneic GoCAR-NK suited the May. this CAR-NK IL-XX proliferation, discovery our Blood survival low the intriguing We data cell in off-the-shelf we at innate propensity excited function. move showed synergizes for program. the GoCAR-NK since therapy our data to Advances, potential particularly so cells BCMA about they

for expect role vivo similar and In faster is is, be scalability, GoCAR-NK may convenience more that off-the-shelf in cell field lower provide addition, play as our and the multiple these treatment. that myeloma selected we the next cost autologous deliver models. since may coactivation efficacy on domain more MC efficacy the for initial in to therapy. GoCAR-NK major benefit resulted which therapy, therapy in deliver and from CAR-T treatment, investigations, preclinical Based a time an step validated manufacture. greater to expressing certain with to We initial studies, program other to believe believe IL-XX clinical tumor BCMA findings, GoCAR-NK cells a preclinical in off-the-shelf to multiple Based cells than potential have our off-the-shelf strategies. we durable on therapy best-in-class our we The and cell a target cell well it superior

demonstrate this in to development seek will program. We our

concludes That additional present program ongoing, programs. of we this Our XXXX. our the end preclinical to is by and summary development data the for of expect

review So of Atabak turn call over the to a our results. financial let now me for

reduction expenses the increased the to reduced and quarter expenses you, second comparable due quarter Bellicum of $XX.X for related loss reduced GoCAR-NK XXXX administrative in Rick. These in in the was second to reduced were XXXX. half and by of million the period the and force XXXX. expenses in effect XXXX primarily primarily offset million to $XX.X the expenses activities resulting quarter compared the XXXX net of expenses expenses sale reduced Thank a of The commercialization The that General quarter charges. reduction XXXX million in due during were to reduced reduction XXXX employee-related in of of quarter XXXX. and partially loss comparable reduction compared to R&D RIVO-CEL-related expenses $XX in of second programs. facility expenses the second XXXX. million activities, second the GoCar-T period to April that second the the were $XX.X for a million to of the was from million for XXXX second lower RIVO-CEL-related our was net of force related in implemented quarter manufacturing $X.X for $X.X the the of for during reported compared

$XX.X noncash second due included $X.X million sale. in dispositions The of the value to manufacturing change to of net facility XXXX a million fair related warrant gain and on the quarter results of loss liability

to balance sheet. Turning our

In As quarters restricted a Finance Concurrent $XX.X closed utilization loss loss cash the XX, to totaled a for million, of which resources to repaid from operating cash $XX plans, which April, approximately prior be the Bellicum from hand cash to with meet taken operating cash current of Anderson for manufacturing was our June Oxford its million X Bellicum debt the believe have obligation. for we and sufficient had organization. XXXX. second $XX now of million a Rick. months of XXXX the will And on we XXXX. acquired in cash operations operations the June Bellicum cash MD from equivalents Houston in of expects cash, $XX XXXX, transaction Cancer $X over the $XX $XX.X compared facility million ended streamline given the Center transaction, to the steps back decrease In year second million call XX, quarter, million. the We of Based current that full half requirements into to million. I'll the approximately

Reviewing X across our the Atabak. particularly Thanks, far our XXXX, we our as pleased advancement in by I'm milestones. pipeline of an potential enthusiastic so programs. increasing of data number I'm anticipate accomplishments GoCAR

next in in pancreatic and the first present we updates BPX-XXX, expect XX Over data our X months, to for cancer. prostate cancer

remain presentations forward expect and our of preclinical GoCAR And escalation. open expect dose for questions. you about first program GoCAR-NK now IND GoCAR-NK program, our data updating the we future we the I our with on BPX-XXX, and rimiducid start our steady including patient in year. progress, data to first-in-human Operator? Bellicum's future, submission. potential preclinical to our our and multiple I'll from excited later dosing For pipeline this call on look repeat

Wells comes our Jim the with [Operator Instructions]. of And from line first Securities. Birchenough question Fargo

for on keeping there way all And toes of Jim. address on and your us with to the a Nick It's question. new register

thing, first the Rick, on XXX. So

program? think, led sort a So interpret in has XXX this, there expanding interest what I as been of any data that's rimiducid repeat to readthrough renewed we'd dose from emerging the

the type. which to think long-standing of a that been now's Nick, I an dose expansion tumor the we've to, is initiated -- escalation -- different cancer the a mode, what approaching the probably is in expansion we're now we the And I you're No, explore of prostate, referring in and end think time ours. pancreatic interest

want to I think is we tumor. signal we by little that more pancreatic cancer a And challenging broadly. don't a very looking a acknowledge certainly all miss not

So is the I think just of this plan. previously really fulfillment articulated

of they data be And a terms Okay. bone-centric specific this able cancer, XXX cancer, that supports patients then, lines that just fail with you from perspective do do number bone a very prostate the the is have mets? penetrate that preclinical of is of treatment? in have then, of you'll to to enrolling And

eligibility to ineligible inclusion or that for patients Yes. anti-androgen for On anti-PD-X those received qualify, PARP a mutant question, are either inhibitor or either an received then have of criteria, therapies have patients for And and MSI-high subsets taxane. your first have well. therapy have for received as to BRCA the

later So patient line population. it's a

and mets, any specific think as BPX-XXX, far data will data have the As patients the bone I certainly the don't in treat as be we we for at but we embark looking preclinical study. translational

patients. trial -- on outlines And some you just X, then those so of the on XXX, plus gave us design, X

at first that the is would patient every receive not level dose So rimiducid?

and X modifications, that's a it's so that's plus some X one The Yes, design with them. certainly -- of correct. traditional

each expect patients and dose-limiting receive and the plus dose would cohort receive toxicity only, the level of would first a in the absence rimiducid. would each second X you in patient cells study, cells So of the in weekly

mean, And -- so first the for that the kill can intensively rapalog what patient you activate then -- you triggers I the what the administering hospital, to stay monitored. are be switch? in will Do have discuss presumably

summary, in of depending essentially toxicity, I standard think care. on it's the failure of

monitored you interested effects patients, will in carefully. be course, and be be as are of this on-target, cardiopulmonary. antigen, these tumor say, off So that with admitted will you'd most The

adverse be event. events we'll standard of treated then construct. and certainly, the then of they'll active small And the for care of the if monitoring. fails, in care if So whatever be they'll receive molecule tensile switch standard adverse activator with And occur, this safety

next with Our the question comes Jefferies. Ma Kit from of line

II the for is the This forward I'm in I'm type be current wondering this move into what bar What response will trial. Biren. to with on trial? Phase of expect BPX-XXX can Kit. we

Thanks, Kit. Sure.

tumor depends it type, So on course. of the

that setting like and I to rate think of we've what the with said be you'd something activity need cancer duration X-month about meaningful a response is XX% see to pancreatic response in a candidate be the XX% a XX% cancer, like a worth rate, durability response probably be rate with meaningful expansion to in to bit prostate on to something advance. similar higher more response a

the thresholds looking are we're at. those So that

[Operator Instructions].

Our next from question of Landenburg. comes Wangzhi Li line with the

the a that line Could more rationale Let's to BPX-XXX. as double bit would to expand start decision with also color the -- you or provide third and you mind dose? factor on drove the into

Sure.

were cancer. portion of as study, pancreatic line think, second in the part the and of you pancreatic recall, in early So I the the treating study, later we

dose activity previously population to in As think, line-only we we to look certainly criteria a second signal. start towards maximum looking We we were efficacy begin for getting study. more the the to I enrollment were the escalation, in as impacted to inclusion the a homogeneous And communicated, population. that dose prescreening for contemplated narrowed and

eager making more back to patients One to there. think on in of so think really subsequent I of in X access light adding have is we're changes impact eligibility. we're prescreen, and third I line COVID-XX the that enrollment, light to

will this sites. be accruing, third-line population that adding now and also several we're and we So second are additional a

certainly say that address benefit, the an I'd therapy problem. So meaningful third-line don't as cancer expect have really patients, available. enrollment as will you pancreatic know, added

approval. accelerated a for So potentially there certainly be if activity that clinical we an would unmet an saw area need high

dose? I your think second question was

Yes.

Yes.

here. So looking the of we're to benefit course, maximize risk

CAR-T their the tumors when on we targeting different dosing the sort studies, of X up dosing landed. antigens had based per initial cells and -- so was And different really thing million and where drove kilogram, in to our designed protocol we decisions that other

of didn't, have be what prior, solid efficacy. for required a tumor deep might understanding we So at really

we're this manufacture now could from pancreatic We study, we as a the kilogram escalation we've cells to and think able million and the evaluate a escalated, think dose safety and been patient. can also into I be we activity that is XX believe cancer we've dose per dose useful. further

consideration, important too, an feasible. it that's So is

what's addition to couple cohorts to kilo. So million our that's per up led cells add decision-making a to I of think XX these

may, follow-up -- mentioned if then, Okay, I a on got impact. you the COVID-XX it. And

presented think, initial In fact, plan, on there -- how a for for I remember you have Any patients year. this was color XC? may I could later the presentation number expect about many how X data much of If patients are patients. correctly, over year the you Cohort

approximately think X the We patients number. right is

similar Got Okay. it. Great. then BPX-XXX IND. FDA-cleared great And to

know potential about toxicity. color schedule? previous share provide you quickly I tumor of any can the the of I but or you think share data the that don't targets convinced what ahead the concern regional the you expectation, more the I any of toxicity ahead on it's and color Maybe -- on if can know guidance FDA

Sure.

So I questions think your IND and the there. BPX-XXX about

in information of data of FDA tissues with level CAR-T I levels predictor levels some expression, in the that lower communicated, of toxicities potential healthy antigen had potential HERX additional activation levels relative think you'd activation, in expression BPX-XXX requested want of tissue, we is showed high on that healthy you'd tumors, on-target higher a humans. to further lower presented to vitro see. expression previously as a what nonclinical of interaction the dependency nice which off-tumor expect of of so as We express lower and with

of in hours. models some switch vivo safety I a think our the were showing cell cells within at those eliminated BPX-XXX kill with mice, additionally, of activation data most the of rapidity we the from looking and CaspaCIDe, provided the of that couple

that of for should potential switch utility toxicity, potential mitigate the support So occur. was they further the to I safety think

that FDA modifications think trial So cleared with the described, of the that with comfortable and some and was I've data the IND. clinical set I

call turn CEO. time. are there closing to Rick at questions Fair, this comments. continue with Please further Ladies I will no the and your back gentlemen, now

much, participating Thanks everyone, very today. thanks, and for

and They're progress As these progress like not always, times. our when for to efforts passionate I'd our making thank Bellicians, is of team in investigators collaborators extraordinary their easy.

patients day. trials, always, As effort every thank They families like our to and their who the too. clinical inspire participate I'd in

free us. If you And contact to and a have feel have additional please questions, evening. everyone, great thanks,

does conclude disconnect lines. participation conference thank you for for and that today. call you the ask please We That your your