Notable Labs (NTBLQ) 23 Mar 222021 Q4 Earnings call transcript

Greetings, and welcome to the VBL Therapeutics Full Year 2021 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions].

As a reminder, this conference is being recorded. turn over like of Dan now Advisors. LifeSci would the to conference Ferry I you. Thank

begin. may You

Thank morning, XXXX Operator. VBL corporate you, Good call. Therapeutics joining you update full the for year quarter financial and everyone, results and thank

website on Dror of issued Joining Officer; ir.vblrx.com. Chief and earlier at Officer. press this and is company's the the available Financial Executive release Chief morning Harats, with me the Backenroth, financial call page on A the VBL's Investor Professor Relations Sam results is was

Before everyone conference and management the as Securities to statements and turning Private within to I Sam, of the Litigation amended. Act Dror, Exchange by of fall Securities the call XXXX, that Section over Reform the XXE would like Provisions of XXXX, Safe are made call, of remind intended to this Harbor during forward-looking Act

March update SEC XXXX, does statements or Any release, forward-looking set Wednesday, call speak or include, available after the statements and report website. prospects, to any to circumstances business statements XX-F. are forward-looking only from involve our risks of as those company's These on with the including events SEC, in on these discussed not filings date. today's reflect date, As uncertainties on the intend today's company of occur today's our made and filings our annual may conference other our things, XX, the forth affect forward-looking press Form that and among in which that

the remarks. that, Harats. audio turn being and As over website. Professor rebroadcast to session a a will the be for company's With Dror? to on will be reminder, our prepared this Dror like call available following There I'd recorded call is Q&A

was success in morning, clinic for and us set Dan, everyone. productive both excellent father the operationally, in a you, year Thank up the progress we XXXX. made good very and and for VBL, XXXX

that the now VB-XXX, stages unanimous trial, committee in this candidate, lead safety is Recently, trial in should as completed and recommendation the enrollment announced of Ofra-Vec, continue OVAL the registrational Our recently the Phase platinum-resistant monitoring cancer. patient independent a that late also trial OVAL X also planned. data made ovarian known as overseeing we

data in endpoint the second would the survival half submit primary are get of the to as first progression-free expecting us to transformational If in VBL, which trial to will successful, half we ready be this this from on ovarian cancer, readout occur year. it We event for XXXX. in a BLA positions a expect of this

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of and based approved data, PFS and on As were including for they have Avastin, to date. the other overall cancer, existing benefit demonstrated approved a drugs all survival not ovarian reminder, PARP an inhibitors

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studies that favorable the product demonstrated have into We clinic. tolerability IND-enabling toxicology since that profile supports completed the moving

ahead. preliminary are I initiate look financial GMP the run to over this transformational review to conducting this year. the To the summarize, year half the with unanimously year Sam being of in study will to VB-XXX, over half and clinical VBL of of fully of recommendation it enrolled, and full OVAL readout in now XX% to topline and of following with PFS Sam, hand we expect the a We year, please XXXX. manufacturing endpoint a second forward for data the DSMC to second go to trial results. population, now in now discuss proceed

Dror, everyone. you, Thank morning, and good

million Total the This general and the compares $XX.X operating was $X.X the XX, million XXXX, December and XX, million administrative expenses Moving for total financials, $X.X in ended million $XX.X net, XX, expenses in administrative year to our expenses and of expenses were expenses. to consisting $X.X the R&D XXXX approximately R&D XXXX. were XXXX, $XX.X comprised year ended and December in general revenues in for in million December million, million, of of compared year $XX.X expenses. million which operating as in net, $X.X with ended

December share, to for topline reported $X.XX that, bank loss million this operating Thank from fund restricted be data for or At like the short-term deposits, XX, of of per OVAL $XX.X million $XX.X cash the from expenditures XX, call. share the Based the over the loss readout we at you. December trial. capital portion of net planned position this For and and on With back or $XX.X current Q&A sufficient operator XX as to compared deposits had basic Phase XXXX, in expenses the cash of bank basic to would a expect X date VBL least morning's the net XXXX, $X.XX I equivalents, months a of will our XXXX. cash, PFS that the year projections, company million. of call ended per

first Jonathan questions Our Instructions] come from [Operator with questions. of your Thank ROTH proceed Capital the with Partners. you. Please line Aschoff

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Sure. Sam Thanks, here. This is Jonathan.

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please X from Sam, Any Okay, patient Phase to trials? number year of Can preliminary guys these thank endpoints? of later us kinds you. sense and data rough for see describe this you two expect the we

the a patients a patient if major works. completely know that or do see field Jonathan, Ofra-Vec If checkpoint colorectal cannot we deadly tumors, looking because even bring if - system including were the whole Dror the Ofra-Vec actually of were that viral we the can oncology in recognize data CDX, to cancer, CDX be trial But colorectal immuno-oncology and cold inhibitor before will will be if from that drug. with course, tissues, treated new tumor. including indeed There after tumor. in shown these with is and to bring or XX% very can speaking. have tissues, results of lungs preliminary with the benefit can try the you and Ofra-Vec, cancer. they tumor. checkpoint And in we the - treated preclinical a T colorectal, the what XX% Cells two as after drugs. they it were if step the In the the system had many a we these them in is actually that that, you you track for Thank Then inhibitor other, other ovarian of biopsies about of immune of call asking treated So, can to nothing see with the immune the patients, to checkpoint or GI treat patients product big, a you, the we alone, the with other therefore, like these inhibitors, of enjoy T-cells in forward question. it’s show into for indeed Ofra-Vec, And immune idea later no it like showed indications, combination indeed, with a and of they you Ofra-Vec on histology with to cancer of and the on and for combination are

If a to it both data even product it's get. bring at time like the time to we mechanism then work trying it's don't avenue, viral of So, very do of and big is this patients a us with are trials a Ofra-Vec. in we opening and important for gut, to positive, patient. If for expecting that that indeed, can least in the spend you won't actually action Ofra-Vec, of the

the that's NCI and do important very with to us. So, actually the that's why it's why offered trial, a trial

part your is this - one question. to answer for So, one

we've will if if a to of XXXX. the indeed the we doctors data, and of are they're we'll in care, Ofra-Vec getting this part evaluate the open-labeled immune From the are GBM. standard And for to there and to are third them a thirds you is new more them be and That's six two repeating are you bringing one getting it control resection, or the XX%. is specific. it's we recruited, months we in following patient conditional successful surgery, and able with talking data. common to recruited them much six it they’ve are about the GBM. PFS, progressed a that know And tumor And going PFS and X, that, we Later data be this actually tumor, and we're placebo. are if it's for actually a When patients patients for seeing X, we are getting Phase six in disease. mean start have become six submit system GBM, And genetic months say to are as this that go get blinded, but we now try PFS of patient which we the will able much to already of come of going same groups, months we are recurring population point of but we recurrent randomized going then of and on, OS, they months GBM. it's and will that But a we in not the is as preliminary patients. in this changing of the in second fully are we what go it's we three to the our trial. as bigger and data, part The six these histology on, have Regarding completely do radiation, And and I'll OS. in PFS the what our number successful in of actually know get that Ofra-Vec, expecting X. a before the coming see we will it will saw we and actually adjuvant, of working singing trial, more course Phase course get the basically, and seeing and that to we are PFS, positive, failed randomized when chemotherapy drug in in expected months seen two get data. when be the first patients and ready If were will will our we Phase enough enough And what approval is to I the if signal can

you, Dror, Thank for that.

the you've what are to having have like ask would start those this to going studies, out that to I tox giving you look you, done Given most for? for when be studies? to closely XXX learned What you you IND-enabling monitoring people, done

Okay.

So, when actually, the mechanism toxicology we as Indeed, in favorable. action, expected actually that careful didn't we the quite - toxicology. was be of see we we were trying from saying we the were to were much

that's that So, there what of if in X low the the the healthy Phase to monocytes. in a know are as will to developed and and important drug, not in way, is that expect drug also dose. volunteers, should do nothing going do although this also we level because is And patients, we the we new to in the increasing developing but look do for a are very just men, part start blood going look PD new trial we most thing, fundamental will and we the to that to not actually going be PK, a will they doing careful to actually that but course, monitor to we will first are you but be just for we drug. able in normally do we every of it's enable dose more a everything with bioassays us in The the

have show and migration we actually stuck So, that's addition, will is and the migration because And that or the action. of will bioassays is get can according right look prevent working the drug dosing monocytes on way to of that at monocytes if we the least by prevent walk. addition, because we - the we from in actually, know course, we indications. can to And go then working we mechanism drug there, that specific the

And needs yes or it just just one XXX-patient Okay. no I The it monosyllabic no. me analysis, to just absolutely a in to you analysis X% you'll more was like that? yes any efficacy, utility, this, safety and nice want indulge question, or if interim unblinded, or say XXX%

The for what we unanimously them are got And green because careful everything very an go light DSMC we in see forward. to fashion. unblinded is

is Our anybody else. interpretation as good as

Okay. right. Sam. Dror. Thank All you, Thank you,

you. Thank

your with Our next of Please Kevin DeGeeter Oppenheimer. questions come the proceed questions. from with line

Hi, Susan Kevin. Dror. is This actually for on

a preparation Just we to the the from any US. timelines in couple know commercial could additional questions wanted I if scope on and us. of get color

gave of in the any us with April, little more? kind a but bit event You

Yes.

we look the the building drive end to getting we strategy, taking here. who's you that order Sam pre-commercialization and with in all give market progress the and not the than you is we're in has - early starting and ultimately research. for this to I'm a and that year, as do, can of at the So, market we to color say And sure drug hire really far. go - the to Trudeau, really out ahead it any early Matt right happy users, the global and fantastic on more access, to pedigree saw been this us logistics so the brought need other that activities background

as really pre-commercialization deep within and that, And for the data. doing the so, pretty really out have we're building we we're prepare PFS once we activities

focused study? thoughts it follow That’s, the to up, more ovarian, anticipate current on in great. Thanks. on will And you KOL the then just do be will discussion or expansion mostly include

Yes.

market a brought the as discussion, great that It's really better the the to for our both we've Ofra-Vec great patient good is poor over cancer, ultimately general. ovarian be from some where And we really advances the some mean, - going table the prognosis there to towards have fairly event, been well platinum-resistant we So, in get on at of KOL as I KOL having goal outcomes think as in moment. here.

involved line It's to broadening the also ovarian ultimately our And do for plan that welcome but into go going but are cancer is choice. knowing able later and over use to think general starting maintenance, certainly, ideas plan on point, OVAL a I with of lines ahead would people investors ask answer platinum-resistant trial be questions, earlier to lively, we go to and just in standard I as market example, really other not here. of from to the fairly on there. questions. we to really label stop be ahead lines, of is therapy, the where chemotherapies go goal discussion, the be the do and and to moving their we is or there the first mean, and people KOLs right care

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responses this It's least for the many to because for sub-objective tumors, and much to a is it at a expect solid that's cancer have all have such with questions. for both with Ofra-Vec of this big go the the doctors, and If beyond the that's coming compound. more important we going actually ahead and data a KOL we will aimed to ovarian of the and mechanism ovarian indeed just drug why patients platinum-resistant what show action in and So, that hope cancer, going novel other a tip ask it's technology new is and of event hints expectation be iceberg is showing the in actually right indications.

all us. I'm Thank looking from That's forward it. you. to

you. Thank

questions. line questions next with Wainwright. with come of the your from proceed H.C. Please R.K. Our

you. of Dror, Thank morning, Sam. questions. good afternoon, A good and quick couple

candidates are data late-stage this there year. know, clinical putting ovarian you your cancer As multiple for platinum-resistant

in sort filing regulatory that a that based PFS you application to achieve needs would so of So, mind, keeping you hurdle feel think that comfortable what data? on do Ofra-Vec

this So, morning, asking and K., for question. good R thank you

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which are with to with discuss to writing, So, when BLA more going won't with then are have And will submission. also disclosing our line results, you discussion course, the we themselves. what stop we the Actually, present in are positive have are the just to we PFS And hopefully we discussion FDA, meeting in And agency doing. will on for analysis going in the agreed results, present that will we much the not just a we the be of PFS. them. than with a we results that the have now, right speak

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course. of Yes,

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the of timing discussed XXXX? you release the Thank to able colorectal know on on confident studies, I you are you. extensively GBM the data by are outside of collaborators VBL. studies in How and but these being done

Yes.

the very of is not for the the as don't half being term, studies the which in it we're have R.K., do feel about could parties. you we couple three the a It guidance So, of in mentioned colorectal one noticed, until third we ‘XX, cancer before, here the first expect but, first we is, we've on a And year that these broadened originally results, full probably XXXX. in there's only months confident, to for reason expected but results as are metastatic third-party timing as get It late be where we weeks. it's results. be those those here could And of we quarter, we sit couple because things those the near you left. now months and know relying the external

forward the timing sure those near make to those naturally currently the today. fit to that extent to things. update that as any in know we that move of wanted there's continue midterm within get we GBM and obviously market And guidance update But here results just expect with with on to we what well. do had So, to we continue the to the the study that, we will

one the as recruit investigators add thing. as six is we sure the it. In depends are were investigator-initiated the just we it I’ll R.K., you saying, maybe, talking trial getting. it recurrent when all exactly and months that trials, on PFS, when are about we And that getting And XXX% be are cannot GBM, the we follow-ups

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So, everybody with our it completely not should this knowing way, is this control. that take in

it. got taking questions. very Thanks Thank my much. Yes, you for

you. Thank

Soumit questions. with of next questions the come Our proceed Roy Jones your line from with Research. Please

question, taking you and everyone. the for progress. congrats on Hello, Thank the

the If population, Dror, going in in you're for remind data would know, How the this mutation Or if time? the data? then the don't and you would revealed us to the by, present the presenting at population would entire be at subgroup, me, fails, the still or you if OVAL, do those are look subgroup thinking same also it? ITD you fewer could status topline maybe the through you I

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Got Thank it. That's very you. helpful.

to the forward Looking call. QX

Thank you.

next of questions. line Jonathan Research. Our come Kreizman your with Please questions from with the Valore proceed

Hi, everyone.

data Any refractory, questions on PARP patients treated helpful. provide the from color geographically, data, most you have the be So, final trial been Maybe previous my or could pool stage, could patient criterias answered. of additional of any the Thanks. in histology, resistant more patients. just breakdown if versus OVAL

domain. is Yes, anything not I to to try will disclose in not public that very be the careful

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about So, we failure, less the of were already we were a maybe vaccine about call platinum that after were inhibitor and failure, time of are platinum. and And they of heavy-treated we are months progressed last disclosing that means about more a than XX% than refractory, XX% were talking that which they them XX% three PARP getting in a we them what about closed them population, even this.

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endpoint we the to hope actually that right I but get looking for, into translate cannot disclose are data we now. primary So, more it

if the geographically and from just breakdown you patients European can patients Japanese patients Maybe all together. terms your of provide in there's any

a and and even Japan, actually from the that's So, FDA we bit successfully what least and it In this will be. at PMDA insisted should the what trial. that's what US most we patients patients to we the recruited actually, XX recruited more. And came expected, that's did,

in the also of terms Israel. number a in we patient quite In rest, and Europe of significant recruited

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Thanks. That's great. Okay, helpful.

at are to any questions Thank back closing There comments. this like no to over Harats you. for would Dror call I turn time. the further

a all you call today, participating for you our all of have and day. thank in you. wonderful So, Thank

Thank This you. teleconference. your We does today's participation. conclude appreciate

time. You may lines this the Enjoy your of disconnect your at day. rest