Bellicum Pharmaceuticals (BLCM)

Robert Uhl Westwicke Partners
Richard Fair President, CEO & Director
Wangzhi Li Ladenburg Thalmann & Co.
Call transcript
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Greetings, and welcome to the Bellicum Pharmaceuticals Fourth Quarter 2020 Financial Results and Corporate Update Conference Call. [Operator Instructions]. I will now turn the conference over to our host, Robert Uhl of Westwicke ICR. Thank you.

You may begin.

Robert Uhl

you. Thank and joining everyone, call. you thank afternoon, the for Good Rick the President With on is Fair, me today Officer. call Bellicum's Executive and Chief this December financial and Earlier released the Bellicum quarter fourth results full XXXX. XX, for ended year afternoon,

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

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

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

Richard Fair

of an update programs of a our our everyone, us. afternoon, GoCAR platform recent year quarter progress summary XXXX. and and joining Good on On Thanks, our call financial fourth full provide today, I'll of for and overview the and and Robert. thanks

breast, tumors, our patients patient candidate in trial HERX-positive to is enter progress first BPX-XXX product solid BPX-XXX development. quarter in colorectal and our in evaluating fourth ovarian, enrollment with first gastric clinical Phase endometrial, in clinical cancers. apheresis the including highlighted our the was GoCAR-T by of I/II dual-switch Our

our to cost CAR-T included allowed implemented cell of quarter, the and In headcount, fourth steps reduce plan a pause GoCAR-NK our refined October, our our on BCMA addition which In in restructuring discontinuation us we a research reduction our clinical to our to focus structure. progress of sale preclinical program, take next-generation therapies, facility. discovery our we of of research that

debt. common balance sheet an and We capital by of offering warrants, underwritten our also our repaying strengthened stock via outstanding raising and

going these significant they some will programs. we changes GoCAR to clinical our in were expect cost While us of focus result resources difficult, savings forward, our enabling on

into me GoCAR Before our of provide X platform, our brief ways. reminder in the specifics I which a of programs, differentiated is go let

immune more in tumor intend system own to or effector believe MC. cancer potent an resisting boost microenvironment to by enhance deliver engineered accomplish exhaustion proliferation persistence co-activation primarily cancer. the patients' and First, our through effort to We durable cell stimulate MC survival, can functional in We eliminate the efficacy. we've this GoCAR and and domain, suppressive MyDXX/CDXX, signaling

up GoCAR potential administration. their to performance, be or unpredictably behave antitumor by effects autonomous doses Second, adjusting interval activity. rimiducid. engineered CAR rimiducid GoCAR Other for by can offering the can GoCAR scheduled rimiducid activity for technology. be via therapies down the the or higher switch suspending between molecular due of control administration we've The our superior controlled dialed

many believe platform safety can our cell cells if shortcomings CaspaCIDe address candidates next-generation designed can Our switch, by they further of for to our our therapies. dual occur. eliminate of controllability when GoCAR switch triggered rapidly toxicities incorporating which manage product the are current improved acute We

challenges clinic. the the biomarker supportive these have effects solid and some effects in the investigations well evidence or help of use demonstrated tumor BPX-XXX. efforts. may solid potential benefits, observed in candidates, rationale have for GoCAR-T may overcome T we've be This GoCAR microenvironment, tumors, signaling believe preclinical that MC previous of the is We of for suited our heterogeneous cell hostile platform particularly the of confounded X CAR-T the antigen BPX-XXX Our these tumor exhaustion expression and and

me Let programs. for update provide now these an each of

enrollment of targets I/II months pancreatic date biologic Our platform. antigen, and cancer issues. study. resulting and December activity up forward the January, have to with findings Through benefit. resolve presented hold trial first in tumor and these of PSCA. and from from the our the by team GoCAR-T gene findings moving shown cancer an in prostate previously candidate, treated plan patient particularly changes infiltration, encouraging clinical biomarker immune data January, answer prostate in cell FDA announced We're their patients questions dose The Phase and advanced encouraging product We've most escalation GoCAR these and dosing data to the trial the persistence encouraged to response. clinical effort and cell in lifted death or benefits with we've BPX-XXX, into in for safety, support that enrollment biomarker an that on had opened stem to cells diligently translate the the on tumor immunomodulation, expression BPX-XXX, patients consistent productive in microenvironment patient metastatic agency we to worked of the focus GoCAR-T-mediated clinical the the In castration-resistant clinical of cancer for CAR-T the hold hypothesized the X to in a ongoing with pancreatic

to remain on clinical BPX-XXX prostate product candidate required as for our a XXXX. quarter both any patient plan cancer, We in update and for modification have rimiducid in proof-of-concept as present the of platform. GoCAR potential We the patients resumed We enrollment in the of I data these first excited about protocol. Phase without BPX-XXX

express let HERX. candidate, that is tumors first Bellicum's which BPX-XXX. program has switch target you update on to designed me Now solid dual been This product

We by is driving by dose efforts expansions trial We chose target dose a demonstrated activity signaling followed platform. plus thoroughly via greater be efficacy X ongoing. trial switch is of traditional these layer MC and safety providing our The X upon it's improve II a escalation an first mentioned, Phase in extra as HERX has suited escalation clinical BPX-XXX reasonable Cy/Flu at received sequentially through and switch conditioning the Dose we because patients cancer to the standard HERX BPX-XXX per fifth enrolled in escalation. kilogram, cancers. BPX-XXX. this and I by our uniquely first be Enrollment XX for HERX-positive Patients to may multiple As trials throughout patient target in followed for level CAR-T antigen dose will safety. believe and in technology at cells earlier begun therapy because validated enrolled that our have December. dual a academic

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

excellent the response thing to was report a observed edition from to an treat receiving announced of we published safety rimiducid North CaspaCIDe the genetically exact best In by modified patient rimiducid CaspaCIDe overall X data, X on cells I'd use way like day. like question initial by you this immune syndrome, within CAR-T circulating provide been, syndrome By At February, at safety address with Within of clinical to switch rate compelling progress. this these case switch. Carolina to this trial of it University of expect autologous trial was and which technology we'll neurotoxicity modified This ASH on posted XX time release of remaining One to of data underway, expressing reported second in hours median enough we XX standard serious of of received investigator-sponsored XXXX, situation. allogeneic administration, context, neurotoxicity the a and CaspaCIDe. patients to trigger we trial X ICANS work cells to switch. of events one to by about mention grade XX% Despite Blood and in days. a case rimiducid validation cell-associated of We X clinical in have X our CDXX final number than CAR-T has safety According more cytokine grade use improved I half hours. CaspaCIDe received of these patients, effector excited and refractory to to keep in switch trigger after caused within digital patients the presented the first Phase XX from is in the T the ICANS, response of XX% will GvHD CaspaCIDe of was nearly T XX% mitigate our safety who our GvHD In have cells. data the was the therapy. to hours The XXXX. quickly to investigator, great publication or steroid-refractory adverse treatments. fully We're reduced resolved report the

only encouraging. forward potentially a CaspaCIDe into time. collaborations the we programs. That own report, is BPX-XXX, adding a number look While of our concludes CAR-NK recap single of this CAR-T our Since to and and set to over highly is case data this incorporated

XXXX, million manufacturing comparable was in the were $XX.X in expenses corporate for full for to XXXX $X.X and $XX.X of loss XXXX. to provide $XX.X XXXX and year of restructuring facility the a the $XX.X million GoCAR a XXXX. during quarter for RIVO-CEL-related million year and effects value compared prior from compared placement the fourth activities compared fair fourth option and in in related million reduced December for of to corporate to expenses $XX.X reported relative results XXXX. comparable change full $XX.X primarily of fourth the $XX.X and commercialization of quarter General offset related the fourth reported million and Bellicum and reduction to $XX the restructuring XXXX respectively, the the of and the periods programs. million by operations and private year that primarily net review XXXX. from our fourth warrant the year and the $XX million quarter in for a due of the expenses quarter XXXX periods in for million of $X.X The million $XXX.X million quarter full quarter the loss a the million employee-related reduced periods fourth million for implemented and were fourth in income expenses. increase a include of Let noncash to the XXXX activities, periods million net $XX operations and loss were million a net fourth and administrative XXXX, year Bellicum expenses million gain $XX.X These in during to million and the and for an and The reduction RIVO-CEL comparable results. XX, expenses quarter $XX.X R&D XXXX brief and to me million the now lower ended to $X.X and in financial million $X.X comparable quarter in of the of full loss compared $XX.X due of sale year the liability.

to Turning balance sheet. the

BPX-XXX received million shares I'll cash current cash warrants $XX the Gross $XX Based initiation prostate and and stock, Reviewing of prefunded XXXX X resumption approximately operating GoCAR clearance December underwriting into of and warrants. tumors. future, in including November about a be Oxford approximately of by sufficient for resources first pipeline our million by under second completed commitments clinical potential million terminated the upon our to XX, equivalents Bellicum shares Bellicum additional stock updating trial of and meet trial advancement restricted with in clinical the for commissions the that quarter offering to looking call repaid operating be warrants accomplishments that on year approximately our the indebtedness to BPX-XXX of XX, obligations BPX-XXX I clinical IND into full Bellicum underwritten outstanding of of in all this compared As progress. totaled our its and were XXXX, Bellicum present to agreement shares million GoCAR the patients purchase I'm our and in for and remain on to XXXX. XXXX, payment current stock. million. and pleased BPX-XXX excluding approximately of We're October, to any of proceeds Finance plans, to all common HERX-positive of $XX.X In cash expenses for other loan clinical XXXX, XXXX. data you planning and common payable and open cash, Operator? pipeline, will cancer, of accompanying In before quarter XXXX. with million solid questions. the of we in exercise of $XX.X forward as X.X results initial expect our excited to the requirements deducting look for future and ahead offering may later now an common discounts, proceeds purchase X.X December of million


[Operator Instructions].

Our with from Wangzhi Ladenburg. Li first question comes

Wangzhi Li

Just a very quick one.

So when you kind XXX could what color half data the in year? report for next XXX the the and we of quarter first data the further on provide any you expect year should this second in

Richard Fair

remind Thanks dose question. second Sure, enrollment would Wangzhi. escalation. from two dose expect of perhaps the level that requires dose for I presented design trial you BPX-XXX, a the or level. the and through On I'll first the that patient sequential

that does it to And study. of for us so bit take accrue a time

second the from safety expect dose first data from I'd cohort So potentially patients and the cohort. some

dose already. patients reasonable cell which readout, the to dose. higher cells level relates X a it with obviously, per million there a kilogram, we're treating at We're is As BPX-XXX

certainly, fulsome enrollment. of efficacy also but still to what X biomarker are we endpoints I'd that we'd metastatic of CRPC. seeing X dependent to course, signal patients be expect of there, will evaluating we're demonstrate for but upon expect analysis a in dose cohorts escalation, safety, So in and a looking


Instructions]. [Operator

Robert Uhl

is me Uhl. of had couple a questions to in I've the e-mail on Robert people from This come webcast. over

away just let fire me with those. So

Richard Fair

Sure, Robert.

Robert Uhl

the trial of color restart you the that the kind so on any they yes, to protocol?" additional become change any the resulted And you Rick, clinical what died let provide comfortable hold? that "Can that in FDA helped the would without patients

Richard Fair

passed study was with cancer who followed treatments. and line developed standard BPX-XXX rimiducid. was of a X by who X cytokine The undergoing pancreatic patient second weekly elderly in received The Sure. the doses release treatment an grade syndrome patient patient

of syndrome, in our However, unrelated patient treatments, and was course. deemed was parallel, with the diagnosed pneumonia which aspiration sepsis to

both withdrew died care of While on of determined were medical That of with the death and Review ongoing, supported that aspiration Bellicum the was family the his Safety only, review by comfort the based that care and these and later syndrome, death temporal requested by complications cause pneumonia and subsequently said, Committee. sepsis investigator patient The day. relationship was the had on of the dose provided, rimiducid, clinical of without couple case trial put modifications and hold date. observed been for about after about a any the reviewed that the to removed some just protocol. asked FDA safety days hold second the to in Once data the trial they patient the additional and we the clinical required the they information the

I don't of pancreatic that they submitted, interpreted that it's complications. they how as assume an So of while was clarify who the was a data died sick that cancer case this analysis unfortunate to we same very elderly ours their reasonable think the patient

Robert Uhl

number technology. case Okay. in Thank a collaborations. of use other one And in you. come question then the the that's about the is report of CaspaCIDe one mentioned of it's "You

And this there help does more So out your for you? into can their BD tell and effort that economics of what hands programs?" report And it bolster about represents just it get those? to you people's kind into us like

Richard Fair

cell really Thanks safety and are cell of a think have case switch the Sure. have And of couple addition or new about a We remain observed, years the embedded. reported more this what partnering particular that safety who at as previous very to report additional it's reported acute targets question, the comfort best-in-class academic those back, excited then any Robert. the open pursuing therapies. most cell it's collaborations We with translate I suggests course, for that toxicities are constructs would therapy. for a useful But ASH some may in in safety to of to we experiences date, having the a solution both really the liability of switch. of We're technology. into for I this say, collaborations meaningful of the therapy new investigators collaborations us. performance

their licensee, CAR-NK remain economics open we to with CaspaCIDe with CDXX compete agreement advance, their the share Anderson the to continues when of opportunistically our financial announced project candidate, MD Takeda. make don't for sense when and a in they That project they this which receive pursuing For and pipeline. previously example, nature our for we we containing deals they from

Robert Uhl

Okay. Thank Terrific. you.


no Fair audience. Thank from turn be questions there Mr. to will back for you. closing the our appears now Thank more And to you. I call remarks.

Richard Fair

participating Thanks, everyone, for today.

If And you as trials. investigators every and efforts evening. our in our collaborators to have contact additional to have effort closing, participate any great and our great of inspire extraordinary day. times. the team their thank for I'd these in who thank and clinical questions, always us the I'd feel free our and a each Bellicians, time. patients our families to most In and They importantly, Thanks, like like


Thank great evening. concludes you. disconnect. This call. may parties All Have a today's