Notable Labs (NTBLQ) 14 May 202020 Q1 Earnings call transcript

Thank you all for participating today's First Quarter 2020 Results and Corporate Update Call for VBL Therapeutics. Leading the call today will be Prof. Dror Harats, CEO; and Amos Ron, the Company’s CFO. A press release with the company’s financial results became available at 7 O’clock Eastern Time today and can be found on the Investors page of the company’s website.

Before we begin, I’d like to remind everyone that various remarks about future expectations, plans and prospects constitute forward-looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. forward-looking could the differ cause those these and of materially that indicated. that uncertainties actual cautions statements subject are risks from VBL results to

of conference statements reflect Thursday, that’s events statements occur update XXXX, does that speak on any forward-looking company XX, of after today’s or the intend Any only call, circumstances made May as today’s to not the and and of date the forward-looking call date. to these

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

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

now Prof. with please go I’d like call the Harats. to So Dror, to over ahead. that, turn

you, Thank good and Michael, morning everyone.

Ron, discuss who financial Amos Joining our chief the quarter results. financial me will on XXXX of officer, call first today's is

of and VBL study in developments year. cancer, quarter rate at interim was productive first of we showing in the successful have XXXX to Most beginning response has XX% very important Phase a least X of ongoing the OVAL number there since been for VB-XXX. objective ovarian The notably, the had analysis

standard according study’s is on and top endpoint of and ovarian to both analysis, an We clinical have in includes this Paclitaxel, MOSPDX week key in shareholders. registered in survival response. and response comparing cancer data to new developments, a as international tumor trial investors resistant announced also from and reminder, with that institutional OVAL, on interim with patients last X resist a our Beginning is of overall Based and VB-XXX we primary existing Phase Platinum in progress combination objective over the secondary strengthened registration The balance CA-XXX gross randomized proceeds new placebo, PFS positive successfully is endpoint with programs. care. of sheets our million made $XX.X direct OVAL pivotal offering

to study. study, in conducted is we In response we a we or GOG approximately collaboration to absolute CA-XXX CA-XXX the rate arm. saw a designed available be Phase arm criterion can the the continuing was risk, OVAL among an of included advantage patients. that XX% in to safety Foundation. XXX XX in independent to the data pre-specified this percentage first is being There GCIG the if in the arms, efficacy our we committee. positive The patients. of criteria order analysis in enroll study this higher interim efficacy the early response signal for analysis to designing with the X The an measure performed interim stage this versus study according was compared pre-planned and goal was study, strict control replicate the treatment in control when the which OVAL treatment by VB-XXX mitigate the of analysis Accordingly, see were monitoring

VB-XXX both is make can absolute arm, there deduction also Since is of the that advantage the higher. that we that or VB-XXX we in patients arm the an that XX% response XX in committee absolute confirmed VB-XXX of the higher treatment versus The the analysis, the the in CA-XXX also In committee XX% XX%. response know combined, the arm of rate higher in is XX% in or is response arm. confirmed or CA-XXX arm cumulative control analysis percentage an all advantage treatment

are and randomized running. we in time trials of that ovarian blinded that was prior coming a seen X response the for the rate in this in VB-XXX we rate as of VB-XXX that are population the good see This enrolled study, of arm control III the data Paclitaxel similar cancer. part at study is can interest From Phase as response with CA-XXX the platinum-resistant it's analysis, patients Phase study that the OVAL least from

is that fever a usually on hours viral Another fever response, Data from was is data. safety distinctive subside trial, therapy. they of even fever. a dozing by classic fever meaning showed In in response the treatment have are XX rate and that supportive since previous XX%. VB-XXX hours. our with VB-XXX and seen arm, developed that within dosed develop finding most information clinical surprising not higher, experience rate XX% who patients response collected we part is is trial of that likely those This gene about based Fever the associated VB-XXX patient a are fever, as with the

OVAL Dr. steering that the Bradley we the committee. featured a of the Following trial the OVAL this professor March TSMC hosted Monk, as analysis, Gynecologic positive interim of data pre-planned the continuation The a discussed recommended XX, by is at on who presentation University Oncology study of planned. of of in were and Chairman Arizona call result the KOL that

not you a If our to the get did replay on listen chance website. this, is still to

built for survival interim second study, overall three months. place arm analysis are which take least up the treatment at a will assess will in analysis two futility. XXX patient This followed for the OVAL is into after There

As we expected analysis year. quarter enrolled this is successfully the already third of this those in XXX patient,

we agreement. combination inhibitor the target approved is tumors. initial application the are sponsored of the by GI testing and trial. by cancer. a activity National This X FDA. patients. clinical CRADA see the other This checkpoint and Institute, nivolumab under VB-XXX There of metastatic in in explore has in And other is open-label Cancer two The cancer metastatic an we these with trials if treatment IND colorectal VB-XXX, in we the recurrent In with announced is in been trial GBM. XX enrollment the launch of NCI, And immune study February, or patients, anti-PD-X will colorectal combination Phase being in

result have ten to to expect patients. We recruiting eight first to seven after

It treatment in can major An investigator investigate future recurrent this gone effect by an regulatory with VB-XXX for U.S. part a study will centers. results top sponsored Cancer and potentially study the led be FDA, with in we Dana-Farber undergoing authorities. medical into the collaboration adjuvant has filing of hope The a study application in if in this recurrent study Institute will GBM patients is neo-adjuvant group neuro-oncologist with and of that that and IND successful, second generate GBM surgery. with

and neuro-oncologist in This Cancer the there shows the a consortium clearly interest oncology by continue National in the Institute VB-XXX of that support to community. be lot

soon We expect as recruitment to start patient allows. COVID-XX as situation

a the in Phase Japan. product patient following we signed Also, an for Recall They license to that VB-XXX their XXXX, required for VB-XXX, study data in the will and X positive Japan. be we agreement to the operations the in that Japan. their and regarding related responsible is intends in licensee enroll which NanoCarrier commercialization for to announced ongoing NanoCarrier, extend study interim Japanese exclusive of with in OVAL supply April expenses to development,

accelerate potentially of up $XXX We approved. our milestones as agreement, will patient According commercial as will are receive can and in payment decision pleased is avenue recruitment or as OVAL, if well NanoCarrier, more development with than and open another the of the in the from of term million market. net royalties, product VBL sales this high-teens it to important VB-XXX commercialization extend the to

of the DDW now MOSPDX models NASH in in May, Colitis. potential of our we Conference, MOSPDX showing our the to and Turning Earlier antibodies at data presented program.

differentiating a pathogenesis these specific proprietary have MOSPDX, of offer targeting of diseases, using fibrosis. monoclonal and We and has that our opens of for possibility and this VB-XXX of they're that stages inflammation therapeutic established approach point shown disease, it in in liver role advantage patients is can for potential advanced the NASH, with intervention. MOSPDX treatment whose antibody the means plays a A

shown antibodies disease. disease in proprietary anti-MOSPDX inflammatory an Similarly, treatment activity to with was reduce bowel

proprietary XX% study of selected rated affect chronic inflammatory as all antibodies the Poster Distinction. top monocytes and migration Our the abstract block and can VBL in a of process. innovative was thereby was

potential treatment MS established MOSPDX We from well on of a a a showed we -- MOSPDX a Experimental the also protected that Clinical This manuscript of recently in mice disease is experimental in published EAE, & the which also of peer-reviewed model CNS recently for in gene published MS. targeting Journal developing data for the as knockout Immunology. paper animal the

inflammation of for Furthermore, VBL block antibodies of were as forms progressive to open monocytes anti-MOSPDX tissue up proprietary, treatments well reduce and shown as similarly These disease. opportunities potential relapsing MS that migration, damage.

potential expected to is antibody as Our can which candidate inflammatory which you in VB-XXX, chronic multiple diseases, study, has XXXX. for see, lead begin towards first-in-man advancing is

also our solid We in for cutting antibody important made progress edge MOSPDX program technology tumors. bi-specific

information We expect to in e-poster few present antibody new program bi-specific upcoming the the our AACR data on Annual next a late-breaking will in Virtual Further follow June. weeks. including Meeting at

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

Cost were were of for $XXX,XXX to the Thank quarter XXXX compared ended March $XX,XXX you, the for March Dror. quarter $XXX,XXX XXXX. the for first quarter to XX, the quarter XXXX of compared first XX, of XXXX Revenues revenues for $XX,XXX ended

$X.X net, activity offset was net the of activity The approximately for million, XXXX, increase $X.X XX, grant. shown first study IIA in the in mainly by by expenses grant. expenses, OVAL the IIA $X.X increase compared quarter and quarter MOSPDX million the approximately development R&D were million related in in ended to net, and partially XXXX. approximately decrease R&D are Research for expenses, to March

$ was for XXX,XXX administrative were of million, for General the quarter approximately XXXX. expenses million XXXX to of the for first the for the and compared quarter net first to XXXX. first income, $XXX,XXX, compared $X.X XXXX approximately quarter $X.X Financial quarter first

of bank million balance quarter had $XX.X of the million. $X.XX a a period At or and per ended events short-term $XX.X were post first couple share of XXXX, or deposits, that March working There March $X.X restricted XXst, capital $X.XX. compared XXst, affected VBL reported cash deposits and net equivalents, VBL sheet. totaling $X.X For our cash, million million XXXX, loss with

we First Innovation. ILSX in Israeli more sorry the $X little -- million approximately a $X.X non-dilutive million grant April, to million were by than or awarded

approximately on we direct institutional was for agreement And finally, and purchase X.XX with several offering the market price an that May $X.XXX registered NASDAQ share rules. priced mentioned, Dror at investors of entered ordinary in U.S. as under of a the sale shares into the per million at Xth,

we private investor some proceeds concurrent $XX.X existing the potential. fees purchase agent invested this and unregistered of offering, from issued gross in a number under terms estimated the second and subsequent to of before to this to company earlier these in our expenses. are same its The shareholders key -- replacement same week, placement, offerings to of registered million offering ordinary the deducting offering short-term the other approximately warrant up In also confidence in the vote shares,

OVAL an With our continuation the fundraising of the operations and was step important and pandemic, COVID-XX the the necessary this we believe uncertainty that trial. to around secure

operating operation expenses will VB-XXX and short-term to XXXX. operating equivalents current Under cash third and and capital deposits cash that fund develop requirements and plan, candidates bank other product our of sufficient -- the quarter we expenditure and expect the into be

further SEC details to our financial, with the filed this For morning. on refer please Form X-K

We will now open to the call questions.

this At go a comes be Capital Aschoff question you. Instructions] time, Partners. [Operator first conducting session. question-and-answer Your from Thank we Please from ROTH will Jonathan ahead.

presentation I oral you, extent to Thank of good recent the the and related discussions given you in guys. diseases? to was describe status MOSPDX, morning, partnership in paper wondering, anti-inflammatory can what

want talk potential I think of is about And happen. present will data. things about especially if when around talk interest mature. to do course, agreement strategic very prefer I an actually they But I to novel there technology, this it only we when

too -- early? And VB-XXX say you indications about bias anything that about tours way might Okay. initial cancer is or how that can

I are XXX say, I is antibodies I it's XXX actually make backup models and bit inflammation. tell we is and I clear, it compound lead just and our you XXX to So, monoclonal for but early, are animal compound. want think that our a testing XXX can when

in XXXX we with is it for will be candidate, will our it bi-specific easier the it when will information X-X, we'll be a bi-specific. when having X-X, so be are start

is XXX two tested in in different So, cancer actually was vivo, already type. the

say that cancer. will going say to but elaborate it different to in it going tumours indication are many breast cervical We work early cancer in and can in first. assess We at it's the negative to we're was I which AACR, believe more and now solid triple

tomorrow we be next for will the have the forward are and that look the It's at going press think release we all they that follow going we that in domain. of I publish the public morning And present should data up-start. that know to a to believe presentations AACR. are to beginning in to going I actually But the week. I

when when And you is meaningful came had of with a Thanks at for March lastly, difference first And do that. interim interim then expectation, XXX three those months on what clinically the PFS XXth, asked the back you patients? better a the have sense -- out?

or very in in we go all basically we analysis interim Because a that as was decision, we that that will an go meaningful we how planned no that with derisk basically indeed we quite that significantly. analysis, that and did this because it very what on know, go are chances the a So, trial CA-XXX time, difference this positive March. be good that in efficacy, have positive got the quite at to see clear interim you was results unique to it study a forward it's

Nevertheless, the endpoint. secondary CA-XXX a primary is not endpoint. It's

to So survival. for look -- but early it was too

going for look So, survival first one going is the that's un-blinded of to tell to at go, going survival. the DSMC an they're going do But course and to time the -- early. go. quite only the time that overall they look at it first us to And be no and there

months is important of and the where median they're and they groups they're PFS course, getting table, statistically very un-blinded first if seeing meeting significant. But each DSMC in they're every in a seeing and the they and group. these seeing time And are always those six are

the very it's because blinded, will we and groups is how careful we cannot give the that data between two a just What information this be saying trial I any divided know. don't because is in blinded on

responding already other direction, control patient the better well VB-XXX rate hand, know the course means we the which that much than the a arm. in the way the on CA-XXX, essentially of from is But very going from response right in are

the expected do see we was response If make a same encouraged. for is see if longer rate, the very than control all and OS the according that of encouraging. studies we it's us high PFS it chemotherapy do much So with really all to historical

and put always public we they how to have responding the PFS and the we that are it see do of domain, not know course, in that we developed of fever are OS. the terms in going on thing look Another we and patients are can drugs which

where this to So third we mid-summer, will interim have all will we be it be. the quarter the for patient analysis in have

we in PFS that will the believe that on, the really would already And even be seeing meaningful later important most meeting DSMC the the of a because see I are OS. be with it be next that would time beginning in and timing XXXX what to

than a is have big study Now already, we to patients. you this all remember XXX that studied. But XXX patients, more recruited it's

what was in because Dr. So do group. XXX at you see you first small what the looking of the it's part see will the as patient Monk saying is, study not following usually the in

in the be that about going XXX to in and about half they're would of be it that the I time will patients. summer, meaningful. of in the XXXX, of data So beginning a believe really the patient have

Thank you, Dror.

in question, temporary I last COVID-XX enrollment OVAL? kind prompting the of Just of of last one have couple months for sort has

assume that because we in at trial the would COVID-XX. a one a so situation almost will surprised be recruited Okay, no like OVAL, quite for were patient

patients. recruiting are We

patients. We are randomizing

bit And way way. are planned, patients to Asia we in And it's not United We both a the major every are States. randomize in in happening and and randomizing randomizing we in but we again were patients that almost as face any a week. are the planning in slower

there where offer that we're deadly centers. doctors of their one patients is I for recruiting reason believe and disease the is about a talking patients to to much in that that the no stopped

the and And encouraged. are response the interim so so, really that develop in rates ones CA-XXX analysis fever

centers offer get all new we came took a So and approach of clinic, at drug. of get this none Paclitaxel them to just as doctor the to an them patient a local the to example, the

So a bit, getting not a affected way. but we actually are significant in

you, Thank Dror.

Thank very Jonathan. much, you

Thank you.

from next go H.C. Ram Your question ahead. comes Swayampakula with Wainwright. Please

staying Thank lot you. healthy. Dror. the quick afternoon, you're of you're you. actually Good questions, answered that Hope and a had. I Thank fine know Couple questions of doing I

you say or third to want sometime XXXX? sure, make quarter will second I said analysis OVAL, did the you interim in just the did For be the

going they No, in is the be third we saying XXXX. quarter. that of analysis interim is survival was at when is And to this is quarter what next and third the the third interim the interim in time I for that no, The analysis least analysis XXX, that's that That's have be three that, XXXX. are months. followed quarter first XXX to going at for overall the patients looking of

has resistant primary all this I was secondary months be look -- to keep overall safety, are to primary All that at that six is platinum cancer, but survival. And the is actually on of or drug if going endpoint the is reason all is from giving adding on the that then is drugs careful has market to on and them one every endpoint on of study overall ovarian if course DSMC allowed you survival. and proved approved life, a not. of placebo none been very prolonging course

And it's know kind information of gave getting the Okay. you regarding study how enrolled. qualitative some itself, for I

it is have point So, us you this forum decision been how tell possible the for the at if any? to of patients enrolled of many

Yeah, know, talking very one month we’re convert the because patients other. to from you always careful number a about of it in

I but that all saying mentioning timeline we March. Europe. of believe delay of Japan now were the right the we actually we were We're It’s the we will going be that all VB-XXX we that we join a we know, meet bit to in was that OVAL at trial. you a in COVID-XX, And the have believe XXX that pace end because there opening us, for that were recruited planning. would patients. As

OVAL to extend decided and it Okay. Talking about in Medicare get the Japan, that trial. good involved

it trial give to patients can or needs to in – done be to quickly else on something you Japan to is that needs that can step? some that how trying and Is is on their then done be – get get the they paperwork what the there trying done? next trial, get be before So some stuff to and and

first, vendors the getting they were carriers and trial are use they one – they all we everything. quite the to PMDA are all going now, the right is none using and to So into talking of guidance for the time significant trial. plan, and big the that And

are the We controlling in Japan. of just the but trial, they taking are part care

trial. a So one it's going to be real

they to will COVID-XX, fourth the going a that But start and quarter, now. careful should we are idea is CRO They if when probably the talking the recruiting local in well now have go future. patients in most is have recruiting everything about that, plan are very And will be everybody right a that we Japan. in XXXX, already in

emphasize so important. want on I Japan why is to

And First, they're going of actually fund of of have going trials patients course, we patients these the of off the VBL, to regardless are the in burden going Japan. because take recruited. done they’re total shoulders where part of XXX all to to have are they

positive. Second last also the but we of Japan course, trial that hope the register will thing that to trial, Asia, this we the be it it in that time Southeast will patient, and expedite in to the able is as if get drug will time will the expedite in and will be they

China. in patient Because drug as South to Japan you have that, from East Asian, need a Japan both actually Pacific in or register to patient all and know you

that a the it's So very joining are they for advantage us, big trial.

conference, the presentation? on Thank that anything outside we of response CAXXX see the could is One for virtual there question that ASCO data, last in you, Dror. additional me,

was I careful not, Unfortunately in very and way. a saying

at it. the see look this data, that that and ASCO anything trial. do say not blinded If data numbers say We be and should or will something won't course, going we're any we're DSMC come about and encouraged. will But blinded coming to patient It's of following forward, really say. we the meeting. Although, we we in be

to soon. Thank you luck good everything very and with much, Dror and talk you

Thank you.

Thank you.

Please Slutsky ahead. comes from LifSci Sam question with go next Capital. Your

everyone. morning, Thanks the Good Hey. questions. for

Just had real one quick.

you've date. be marker. if biomarker, future on as great those baseline data for Regarding a of throughout potential studies any don't a seen there based with differences, the is used prognostic clear VB-XXX that And the though. and seen will that then you take blinded, in you Is Thanks. know in I this to that fever you've who data some do the on fever? get between a

ask an patients doing Sam signal ourselves Because just that's a if is So, excellent fever the better. question. we are always

So, actually, treatment between in the is Karnofsky there untreated no group. and different the

better don't we one because that develop we the So doing develop they're well fever. one Karnofsky fever compare when or don’t cannot that -- it. say they a a in better are see And we being,

that And map it's that's we're published a cytokine actually, previously, increase And not fever. but talking of or the already with fever, by IL-X not that there is a about. this we with very a unique, an cytokines elevation a increase biomarker way,

develop looks the already all from the a fever, scale potentially fever biomarker here that first, the that, to one But trials, the at patient with anything looking they in Karnofsky it's have a a -- that the are us different like second ran the is many in a So not we like it trial, better real a response. higher data – on signal VB-XXX, they're as or a although is usually drug. they the

or XX% patients if and than a response be of the has OVAL because you XX fever you we more it mentioned, sure to more as VB-XXX had rightly not than with trial, I'm XX. see calculate about group, actually total

So close to it's very each other.

what effect it because have So it's meant it as PFS one, VB-XXX patients OS. saying depends good there seen created between PFS an a this and very correlation all were with is on CA-XXX we on the resist But OS. response, be to response, before, CA-XXX will referenced

exactly and group X that see we – we patients. the that's information usual, this a interim in than had when analysis, more happening And we a chance got in in first we because what's it Phase of saw the could

better that PFS, have seeing So they on have OS. keep they have better we ones a the that response, a CA-XXX

the see chemotherapy correlation a short case even chemotherapy, VB-XXX, PFS with couldn't it's is the because OS. as We a with all that And reason a chemotherapy CA-XXX you with between believe I response. responses. very they any we're that response, when know seeing long with And that's are not responses that the have and you and find the very

that. Thanks. Appreciate Great.

very Thank you much.

you. Thank

is from Valore Your question go next Kreizman Research. ahead. from Please Jonathan

Good Hi. afternoon.

on been So have studies. Maybe Japanese one answered. again, most of the the questions

we there know of differences genetic and BRCA – terms percents are instance, populations, So the between in for patients. of

there So are you for to additional versus the patients any need patients? original the study factors clinical European Japanese placing account eventually with your

that's think in have CA-XXX wants very the need of less CA-XXX And is they in cancer. ovarian trial. so actually the easing, they behave similar bit the to way Japan to differently know we Americans, Japanese groups But in in behaving Caucasian, because I China patient, one anything are So terms case African reason a Jonathan's the bit biomarker we that's that they'll of these change as ethnic the a not in a fear and way, behave didn't by have that patient, group that start a differently. to the

maybe maybe could even waiting expect provide the as situation obviously, then And GBM severe. the deadly you or when as study ovarian Nevertheless, you're that more for kick-in? GBM deadly COVID you more to Okay. improve. you mentioned to So is color on

to color So, you when on study expect maybe more provide if kick-in? you could realistically the

centers it was to little pandemic. basically this IRB pandemic, during reluctant But approved. even was even to during that, approved a answers. at basically conditionally open But bit trial. the in Dana-Farber the say COVID-XX get the the approved I'm must I They some middle the of It's pandemic. So needed

that New issue, open them So of see them to wouldn't to a the California, we're not right we're bit center it’s we're are it's little an are I waiting in now, planning centers one some where actually, in of now. is the York, looking good

much when more say on to a opening really centers centers. will that silent it's be we to until Right will we clear now, picture, prefer that know course, market have we So we are something. when come and of open the we be then, back easier. And will the

in trying bit a if But now. in reluctant are York, already open they centers little then the try right keep centers on I like in California, to they're are now it's patient. for won't a anymore, on to places we are be they they of recruited it. recruit, are it will -- new New and Most medical studies very to open believe patients, open trying difficult, course difficult trials, to If to work

great. for details. Okay, the Thanks

Thank question-and-answer I now have the remark. for management end gentlemen, call reached and we like would turn you, of ladies the to to closing session. the back

thank call. everybody Have a joining for you, safe. and day keep So, the wonderful