VBLT - Earnings call transcript Q4 2019

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Operator

Greetings and welcome to the VBL Therapeutics Fourth Quarter and Full Year 2019 Earnings Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator instructions].

As a reminder, this conference is being recorded.

pleasure your my Mr. now is to host, introduce It Advisors. Michael LifeSci Wood of Thank you.

You may begin. now

Michael Wood

VBL Good page became operator. participating results call website. Harats, this the year-end can you, and O’clock XX:XX Professor Eastern be in today XXXX the Dror for morning update will corporate and Amos of the Thank and morning A release at today’s for company; thank CEO Leading call Therapeutics. you Ron, and company’s with available press found of on Investors be CFO. company’s the the financial results all Time

of Act like uncertainties Before Harbor XXXX. on statements we XX, after Safe for statements that these that cause call intend events speaks actual date. begin, and Any does various remind are forward-looking company any indicated. results VBL to I’d forward-looking purposes plans, only that circumstances the or forward-looking to reflect date, today’s provisions expectations, those not to under about subject cautions prospects, statements update materially of of conference constitute today’s of and from statements the remarks risks Reform today’s these Thursday to forward-looking could future the the made differ that the as Private of occur XXXX, everyone Litigation March Securities

company’s a being call available recorded the is rebroadcast reminder, on website. the for As and will audio be

there will brief mentioned, participants remarks. a a all mode, are be operator the and session in As company’s following initially Q&A prepared the listen-only

call Harats. go CEO, Dror I’d that, Please over turn like to Dror. with now our the So to ahead, Professor

Dror Harats

out our good will and XXXX. morning, we Michael, discuss Thank for operating lay highlights and plans Today, our you, everyone.

year-end hope today's discuss Amos VBL continue from Officer who parallel we generate clinical and both our lot of this on have progress in will lead are programs and Financial data throughout our to which Chief Ron, well. to expect ahead. trials me new a VB-XXX year our financial is significant made our advancing and results. MOSPDX This momentum we year, for the will XXXX call the XXXX we three candidate VB-XXX Joining

year So as we look the potential XXXX company. for a to turnaround

data Let in is will resistant interim We readout update is patient in the first is platinum to an the in controlled response cancer seen for will completion ovarian Phase the analyzed ovarian study patients. pivotal VB-XXX announced evaluable the of rate, investigating end blind The first with me help a in replicated on in X XX strict enrollment Phase X OVAL focus which analysis which will know on for be us that study analysis Phase X recurrent criteria double in potential-registration and quarter. trial. with cancer. OVAL analysis begin CA-XXX December to being whether our the randomized This this VB-XXX according GCIG is outcome expected before of the cohort the positive

once the immune label cells turn will into study, if tumor VB-XXX tumors which immunologically being investigate to with is can an hot. open from looking look we As The Phase -- approved been We Cooperative U.S. providing a or soon update Research an That CRADA. in XX% reminder, This saw and IND replicate is metastatic response CA-XXX has has a checkpoint sponsored immune here. of application and the launch by in results the clinical the the The FDA. Development by analysis. Phase Agreement cancer. inhibitor under announced we In of treatment National being DSMB of Institute, Cancer colorectal nivolumab anti-PD-X VB-XXX the of to rate are the drive what we colorectal forward in the study, XXXX, and with combination very rate to trial in cold X. is study the priming X February

test overall well including tolerability, and safety readouts as tumor to and histological immunological addition In response, study from efficacy as endpoint this evaluate biopsies. will

by have of expect end or XXXX of XXXX. the beginning We the preliminary to results

Massachusetts and General UCSF, for patients will VB-XXX study on in recurrent of of study this Director expect surgery. Meeting and with an we of at UCLA, medical and with Kettering of and at The in Dana-Farber analysis Utah, XXXX. new in following An to the is sponsored Texas. recurrent Memorial were top This IND study Cancer for Hospital, into The in attributed trials Sloan VB-XXX launch investigator-sponsored that including GBM for with quarter is Neuro-Oncology second group by gone Phase study the a of XXXX collaboration neo-adjuvant Society effect new the treatment unveiled monotherapy lack VB-XXX this conducted concluded Neuro-Oncology GBM study Program. and XXXX, planned by in which neuro-oncology a This patients. Institute study second being in Annual priming this between application X the University X will Phase November VB-XXX investigate U.S. in the study second study. study center, UCLA FDA, University the randomized outcomes Professor GBM contradictory of has GLOBE adjuvant were control Dr. Cloughesy, in in Timothy the Details undergoing

If successful, can results study our part safety of filing the that with will regulatory be potentially generate authorities.

encourage which December were peer-reviewed these Phase you the Phase VB-XXX journal would X the read studies of Data and are Neuro-Oncology. published I issue online. X XXXX manuscripts to the in from available of of

article and as doctors learned You earlier may discussing VB-XXX also this lessons available in Cloughesy in be recurrent the interested path Wen forward trial It Times by this and month for in GBM. from the online Oncology published well. an is

programs. MOSPDX our to now Turning

using currently tumors. a toward target is BiTE bispecific whose expression our preclinical investigating bispecific two lead The antibody as to based MOSPDX bispecific have developing one indications. tumor in cells kill second immune-inflammatory separate and on for antibodies monoclonal are proof-of-concept candidate an presented are classical IND the and multiple antibody a cancer specifically induced designed approach We advancing for the being We antibodies filing. for previously programs,

session take Association of AACR breaking scheduled originally American year, this XXXX was or at Research Meeting, In will continue program place with prestigious and later of only to program, for the which MS, situation probably to the the lead potential Cancer NASH. New advance indications, data development accepted immune-inflammatory the year. for this from for the Annual but a our inflammatory RA April we the due were antibody -- MOSPDX for late news COVID-XX

clinical a candidate signed Fisher have quarter Scientific, lead of in service with for in of submission development. expected production of vendors Thermo toxicology leading second Pre-IND We agreement the field, XXXX. for our the [VB-XXX] for antibody is [VB-XXX] and one

European XX% or Liver EASL, on of Study Digestive Crohn’s Week Disease well our Congress, the for as these Liver in Annual and and were to target will Conference. at for the as or take data Actually to data NASH disease the this this as was our for MOSPDX conferences International a We present place accepted Poster of as forward at year. new category the of was in studies DDW later with look all both on the DDW Association abstract presenting Distinction. selected rated top We

summary, are programs. R&D pipeline the being made our our of execute In continue proud progress as to across we all we on clinical and

XXXX our and have next couple announcement in beginning to the cancer MOSPDX We weeks of catalyst results oncology. expect of and with in interim in meaningful throughout programs ovarian inflammation

XXXX. the million quarter at approximately with year-end, take financed into the should which bank us in $XX well are of We third

business. quick to say about a our relative COVID-XX to want word I

outbreak continue situation. our ability late-stage operation good OVAL for the obviously to in to continues VBL manufacturing our by COVID-XX ovarian today, GMP of has this the not been cancer the production relative affected have and with ongoing pace, trial the by drug with facility precautions required our patient As enroll in we has VB-XXX, small situation. Since the own of this in-house effect necessary

financial the CFO Amos? quarter. now over call the for Amos I the review results Ron, will turn our to to

Amos Ron

government ended approximately in million Thank development ended compared XXXX. XXXX. of $X.X XXXX, for approximately XX, and General, grants year million. December you, year revenues expenses million VBL ended for reported $X.X We same December XXXX net to compared related million, expenses, in marketing for the year in were XX, and to Dror. December XXXX $X.X for $XX.X to Research the administrative collaboration the XX, million, the were same period $XX.X the period after

the compared cash candidates cash, equivalents, bank deposits per quarter $X.XX in and of we for December equivalents or and $X.XX million and expenses loss share XX, and year $XX of bank into short-term December sufficient product had bank ended to million XXXX share, deposits or $XX.X net third XXXX. a short-term restricted million be cash, our and ended of $XX.X the operating year loss of VBL and reported the expenditure requirements fund other expect our cash will net per develop to XXXX, We XXXX. At VB-XXX XX, deposits capital XX, December that

with morning. filed details to on financials, SEC refer our XX-F further Form please For this

We for will call open now the questions.

Operator

you. Thank

now [Operator We be a session. conducting will question-and-answer Instructions].

from comes with line the Oppenheimer. Kevin your Please Our of proceed question. DeGeeter question first with

Kevin DeGeeter

to cancer study part ovarian regard interim of with remind can evaluate Dror, of the that off analysis, option is assessment? an resizing the us there as potential to First you

Dror Harats

and we a we because the of at and you Thank you, rate are all resizing response what you this very saw tell is that would due is at survival Kevin. survival repeating see interim hope to a correlate primary at -- the that not to overall point. that know the response there overall is the And will endpoint this expect analysis Phase trial rate with looking CA-XXX. we think if be in as interim the we can I that rates don't remember, analysis X survival. I looking and that we response are of high

a this on change will but that later not become and on, So point. much be it other question important in be at your might later more analysis, interim might a there

Kevin DeGeeter

currently against to light COVID-XX you the completion the ovarian with how enrollment your for do of enrollment? definitely enrollment and is unknowns potential of are in guidance is for the the for appropriate complete current number market? you of of And background cancer Do about timeline regard guidance still kind timeline in prior this for trends in providing of question, study, the that of think think

Dror Harats

the because surprisingly right weeks the pace for weeks is very in there looked happened late not patients, these maybe and good we at last what now. So much stage is and a in or that enough, recruitment going couple three choice rate last of the even

line in of a bit of wanted. line even are what We ahead we or

right COVID-XX and and we open States with very is now. In in any not know should Israel, But all nobody course, Europe. Of careful the in United well. yet going are very the recruitment in be way we

we the don't had next now, we couple it another on today, in effect to there of looks what know saying, but want we recruited. don't happen see the And don't will getting say opposite, a therapy, I have those as we right right the getting randomization. So patients anything, But now. because And major recruitment was weeks. the I are even

that believe to be different -- believe patients. we’re in know, a that you I So at I effect the -- here will much IRB have where needed all Israel, on I'm and also having we in treat a big less trials oncology I the and as but the somewhat Committee trial every look trials.

Kevin DeGeeter

from with One validation may to first, presentation communicate I'll thoughts to more at queue. in clinical in With the least that being acceptance That's their to? whenever suggested prior for then the your late abstract is not there me, AACR, the findings data, sponsor meeting the context to the as congratulations be to of conference, to moves of see that they data for science. future to has whether the sponsors that, of data terrific. to AACR, Any some maybe prior rescheduled ahead for for date. back may of options if rescheduled regard the breaking penalize at get the terrific it's publishing

Dror Harats

you is that and considering that information. is like we'll to that don't holding. it right market if were breaking important And it. we will would what are to come that. delay very guess to with we important accepted we definitely see timing We’re we But the I late this for to back it the think news, information can have

Operator

you. Thank

question. Our the line from Capital. proceed LifeSci with Please Slutsky question your Sam next of with comes

Sam Slutsky

of Could GBM as investigator-sponsored quick. NCI a size the to each? remind real you Dror, and standpoint financial Thanks. of just as the Just, contribution us from anticipated well studies

Dror Harats

Okay.

we is we thing study, drug rest support money definitely, very and So is NCI amount small the do all care our administrative. paying And by of major it's the only a actually a contribution, for them we taken that because with the for to the data with investigator-sponsored actually And data grant to so that giving U.S. government are of NCI. an the monitoring can agency. and you of we be mainly in education support is GBM, will that the line trials the that submit them in trials are the

we we is to in it agreement and the VBL doing that with belong with to together and centers data submitted And actually be have them, allowed the that will these that if these major agency. be is that we very in for a indeed the patients. randomized positive such There And will trials, important get GBM. need the recurrent a issue results in

Sam Slutsky

of then of how that? size enrollment each, terms And are in thinking you about

Dror Harats

the in hot. to that NCI study to to colon the oncology. cancer making the actually GI And single-arm of would be trial, are if indeed course see, an for extend idea then the Enrollment tumor open planned in to if be is just case it is other indications we

the that working. that's as are combination flexible was we're toward end the is the about saying recruit planning because that so why might to already and going And early year. data patients we see colon very plan be was here, XX that cancer. will will of we But we actually that's actually for XX to I it to see And be I saying, this

patients on it. soon are if then we hot. if extend eight of doing to We this biopsies making indeed, And all will after very seven we course, do tumor patients, so, are know and the we want we or

actually terms as trial. In blinded a control randomized planned trial, GBM the it's of

end come believe from I MRIs. if trial. one will a see already things And meaningful other that data I will we in back full the group on, plan it's maybe operation getting the will about recruited. come trial So can to know the is Because will doctors you XXXX two by will see have not will VB-XXX. the that when have blinded tell getting arms standard-of-care we the us, second and they of is study it. and the we they But that half which actually because the the of the is results the XXXX,

Operator

you. Thank

from with question next Please line Wainwright. comes your with H.C. Swayampakula question. Ram the Our of proceed

Ram Swayampakula

questions. Good afternoon, Amos. Dror, and A of couple quick

before one this the interim the expected quarter. analysis on first The end of

be So, we see, outside data the to that that would get would to from in XX a what be feel for later? these presented look the total better we what of out CA-XXX expect for data so trial -- patients, we other

Dror Harats

Okay.

interim the percentage fever, most that what -- But a Phase So, at we we see seen talk that population, least analysis, the you be the thank as for are if the in population, basically RK on response tell develop which designed as interim are market we maybe to that do the see we will with to will it they enable that know question. CA-XXX one in blended that we data the was a the VB-XXX. all In do on total the disclose response what able the about rate important thing good we've be us way X. is the in of

chemotherapy. better if it's no-go -- are all go is than designed. we so it’s much the if the are we where are same So not that's And not the as chemotherapy, we how if

response RECIST to response in between X response mentioning had a and vice at go least together This won't very can primary way. in to study in RECIST disclose the more on. and -- are our patients is survival that a before, going exact group. saw going able correlation CA-XXX disclose later this tell The But endpoint. response, although to who to not And we we this. CA-XXX blinded -- each is interim, not was a the have I but information have I is to a have be you a this in to very good trial, We this number as all about the aligned versa. usually Phase by this

at interim for and patients will expect assumptions already of next have the take this trial and going according and planned recruited to that are XXX PFS mortalities was at when we least This analysis, survival. we to place we point. randomized In the of days, look which follow-up at XXX to number

Ram Swayampakula

for much very you Thank detail. those

GBM, it as of used as that Regarding FDA -- study the could in go part you ISD be could filing. said

that you to on that to a these still to addition to and or can studies Or in So still the FDA? for we the something will should the FDA to do you before take -- elaborate that, expect approval? you else need data take you potential is you do that GLOBE

Dror Harats

which randomized So so we our came with in weren't in for thing when have primed exactly randomized that's that neo-adjuvant when of that depends trial, VB-XXX a trial for a course doing us, Phase what results and GBM, be indeed what all we this would has that and repeat If arm we then a far there is X on recurrent we do the control controlled here, of and adjuvants major a positive. seen are standard-of-care trial VB-XXX.

So the Avastin understands taking in while everybody together the and trial added data with the the the VB-XXX blocking result drug. expression have of actually where the in to X Avastin for is and that out Phase what we GLOBE target happened drug the the that actually was of

that data, all will of So, we to that are new we depend But trial on course, I believe all together able file to positive trial with running. of the agency. it's these be these

Ram Swayampakula

kind start some share the and the for program? the clinical indications as with what us of about be and color, on may talk cancer, accepted One know last at be so which you're able the of in AACR. excited, to too the question. a such the we timelines potential much preclinical is On program us for you sort you clinical have the you could on little MOSPDX that of data development I bit about plans data far, could But not like that provide based thinking

Dror Harats

want what because can’t I'm I thinking say say. what and I'm think So trying I to to

working data have And in indication. it one which we And lead indication so you very go of there are we that the that two will indication good course, we in are more selected testing then different we candidates far I can And it's Based with. to compound. forward. basically already tell than now that we and go we So, on choose forward want pre-clinically. the to have can

results are and everything do The go and And toxicology and produce compelling. course, quite it have will GMP of we in with needed. that, to

to a looking plan antibody basically There the this CDX of now We see issue compound. repeat this one more as safety not arms with testing an to you is of having far, some there bispecific We where of are systemic do right used we at always so it’s we sure there. are much but deeply of didn't that effects. any cause side be that when

are We much provide But year, soon. there. I doing this definitely on more also more will to considering information some elaborate very hopefully later [species]

Operator

Thank you.

Your next proceed Roy question. Jones the your of Soumit with question line with from comes Trading. Please

Soumit Roy

off, ballpark you give one is question you trial? could more And -- fully it when earlier coming with one data have the over -- the be could when this Just a you us for interim And us little February? like remind will question. Phase think completion or in enrollment more cut the March this of month, X data I up is when

Dror Harats

So thank you, Soumit.

in testing. that that patient responders were we have the least a call For most We will what you follow the they're see either the interim do interim if a non-responders. is way is in from the days familiar be apart and to have result of a analysis, have to which reduction have add to criteria, have each actually XX% if the or there definite to confirmation at that we has to then least And GCIG trying XX response. with XX CA-XXX you're it analysis patient at you for

whole then finished second we I follow-ups. And the of some we So January, had on first or week keep of course, recruiting in to the cohort believe.

will will the So are information with there able some and not before in why, actually information, cutting information we but this you is that of DSMB to come be the can meeting as will time last the quarter date the month. many have just the that's the of this end toward we the end we the for week. And from have imagine, only days

going full -- we about be we of last XX toward in by course, in to but or of XXXX. depends the from according have have it will believe or a if the patient mortality this it in, full months of recruitment we even all And be that the that of results maximum patient results calculations, the trial, a months it on full to we the the we XX of number trial. depends will last don't from end see get our If can the Regarding the to then all are and it events.

Soumit Roy

on have see And you expect helpful. you, it. that CRC liver see us more? where very you trial, just is you inclusion And give on expressed Thank there more the and I probably VB-XXX an any operus? that going you Got common really criteria that's is of to color noticed be mets, Could to vectored that? they’re

Dror Harats

Definitely.

with metastasis. not patients liver have not will And big go agents. And a call liver surgery stages, one most to -- what much big, liver that Swiss colon mets. know we If them metastatic these thing. them, you in to the more cheese off it's about met biopsy. And almost cancer too have problems. the the patient you for easier are or are there much take first all it's it's to liver do all reason of You That's we quite responses talking of have usual big do they cannot anymore, of that if usually chemotherapy when the the and the basically that's metastasis,

after VB-XXX that a then the nivolumab. So with combination -- will because every prove the then is after patient and will with, immune tumor. cold we priming biopsy each an have biopsy biopsy have that start And and this depend to here another patient on so we will

the systemically of adenovirus liver, having cancer go we metastasis important. There here, about injecting is the actually lot is of to colon because liver. metastases XX% a benefit a And very liver new the liver vasculature. and are the So also go will are what to

we results target good be And a that are one indications the see hot next the carcinoma. same it of then for positive way we it's we hepatocellular for making us. that if in very in did -- do ovarian, indeed, So might

Operator

you. Thank

from comes Kreizman the question with question. your with Research. line Please of Valore next Our proceed Jonathan

Jonathan Kreizman

So CRO potentially recruitment of initiation the we’re the of pushing and some even slowing trials. landscape certain beginning to impacting coronavirus an down see and maybe dynamics off

are of expecting So in or situation initiation the how as seeing expect factors then are these for the And to going see the you coming dynamics much impact of the months could evolves study? trial weeks, GBM the any what coming you forward?

Dror Harats

Thank you, maybe Jonathan. Because study I will are major different is there some GBM, let's the start GBM and separate there it have the major is more saying, a some a trial, trials. are in in -- people reluctant NCI, into need. a were unless to In might as the say it trials trial And not effects. need. -- you

of So with effect is as today, and as the far company there on already. story no surprising this COVID-XX that's

-- And later little even the up cancer very a all the you catch so skip all far. terms we and unknown to quickly believe we're planned recruitment that have do trial, area. I disease we'll in somewhat that an will be able In if see ovarian as delay, we But unfortunately, on. know of on

with now the rules can know we have how got. every they I to trial. It's same the here Health a Israel. you from got from sponsor agency. run that in right thing you a of of got we every the flexible lot Ministry I in And more sure that tell are for they the company, I can the what from letter tell letter Actually much

look is you can get thing as and delay So try in and a if monitoring, tumor a do it's there monitoring, and is it's or patient is distance the to monitoring okay. get delay The it the If imaging, in monitoring. safety call major to rare there drug for a okay. we

big just that So on. to touch the trials have running virus. with can the the patients. you in that is primary are want how make now are everybody sure going die pharma, of I I'm believe and because the we also, for the restriction on them together I'm working don't benefit we from keep studies in names, And won't of disease mention working patients with on but their touch I We to all because

Jonathan Kreizman

have I follow-up. another Okay.

So trials this and seen PARP combination ovarian agent. testing during quarter one competitive PD-X we've two other in cancer, with the with fail a

in And as medical are terms on studies the in these? possible combination accumulate, learning data realized a with as what a the last PARP either of VB-XXX being study of one therapy further therapy? ovarian benefit progressing is of the these community So year first as combination a line since introduced with what thoughts your potential is

Dror Harats

of a in tumors, bit depends you and all it it's using testing. of actually and think I to of picky again in Unfortunately, and patient inhibitors of doing inhibitors, or patients’ is tumor keep on trials keep are that failure cells and again these type and in a the little some repeat repeated So time have PD-X mechanism on biology a don't doctors’ because -- that that way the using and work to on time these there trials. people you work the drugs the action the they don't cold And on. cancer, ovarian checkpoint

the a our to into Having with be combining some so course, drug drug cells by are a tumor. there, because cells our are the of long then responding actually said patients you bringing very that, inhibitor immune a of reasons actually we tumor, might checkpoint that the after I one good believe be why idea, shut they're the but inhibitor stop that major time thing. checkpoint responding will off have And might a adding of immune because period now they is

there. are in we are we running trial are exactly what models, into combination the this going very about more going least that because that animal learn much colon at that's know from We And well. we it works to to cancer, do

of that a combining idea working combining others, I regimen. but of believe of drugs a it from completely ways action more kind that that’s -- terms in different might with I PARP In of because it say even sense, be mechanism it's makes different will inhibitors, good and was because like VB-XXX the

OVAL will with positive have We results our think to in the carefully very trial.

come inhibitor we to should time at should need or the basically maybe is we a this this the coming some on, be next all failed We -- that in I'm Phase most done line. have PARP and weeks, a and work have vaccine almost even in Phase patients because trial we and repeating add will step? X will where the considered we patient remember to recurring all Should next tumor all that couple that OVAL is it when are PARP we later X already the time are we XX% the inhibitors. be to tumor to we that a not sure is got have add if all And response What say nevertheless, at it on. of the in But of rate. you this -- right basically first first where as things already or the remission? failed trial

trial we So progress. are and PARP vaccine, this repeating it for that patients its be failed major that a derisking if and even a will inhibitors in already failed

Operator

There management back over time. any you. are to like I'd for no Thank this closing turn to remarks. at further questions call the

Dror Harats

very us joining for much. good Thank all on Have and day. safe. stay you you thank a this So call

Operator

This you. today's teleconference. Thank concludes

participation. Have You at your this your for you Thank wonderful day. may disconnect time. lines a

Notable Labs (NTBLQ) 19 Mar 202019 Q4 Earnings call transcript