Notable Labs (NTBLQ) 15 Nov 212021 Q3 Earnings call transcript

Good morning and welcome to VBL Therapeutics Third Quarter 2021 Earnings Call. At this time, all participants are in a listen-only mode and please note that this conference is being recorded. A question and answer session will follow the formal presentation. [Operator Instructions] I would now turn the conference over to our host from VBL team. Please go ahead.

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

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

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

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

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

good [Eric] morning, everyone. and you, Thank

new Officer, is the on Sam will financial results Backenroth, Joining discuss call for today's Chief XXXX. Financial our third quarter who me

believe our for and programs be going XXXX forward look to on objectives which to year VBL. continue strategic and is execute we to We development transformational

indications including high the VB-XXX the data overall cancer. co-primary We endpoint from clinical III progression from phase have trials survival multiple ovarian expect free value in to in study

studies antibody first our beginning diseases. treatment anticipate targeting VB-XXX, evaluating of in monocytes also the We human chronic immune inflammatory for

trial III OVAL to of to survival of compared Also, our of in will phase This in XXXX. which the are we anticipated the now year the include to we the forward first PFS submit the year, milestone of study the overall projections, study trial the looking enable patient of is readout XXXX. on second Our complete of BLA were overall in in one review, ovarian free endpoint we enabling and have population study almost The next DSMC in first targeted XXX%, which total cancer XX% quarter dataset and over enrollment to to important to half expect a successfully clinical ahead not next plan a meeting particularly readout of if VB-XXX of based of potential the another the endpoint original primary enrolled quarter population. in has XXX% the has expect registration is a remain endpoint, XXXX. the which co-primary of us survival progression

colorectal mechanism from In the the half from addition trial GBM investigator data sponsored to in XXXX cancer indications. and solid first also VB-XXX believe of change XXXX care and vasculature tumor expect we readout the targeting of We that of XXXX. its immune the tumor potential based in multiple of ovarian half second in dual standard clinical in in action, has preliminary recurrent cancer to the recruitment trial VB-XXX the on of the in

approach add promising in initiate chronic development targeting our may the growth VB-XXX candidate program our crucial advance a XXXX. for and inflammatory continued on VB-XXX we’ve immune VB-XXX as and and VB-XXX CFO. office for believe continue expect the landscape targeting Based human recently the a and to the anti-inflammatory company diseases. new appointment to we Sam in our lead immune commercialization preclinical To We have are the of the data, As of which and of in inflammatory management of for study indications. that applicability for prepare our U.S. agents first by monocytes monocytes high a value in addition of Backenroth opened differentiated specifically to range pipeline, our for strengthened board a

to go a in attract Mike confident Sam, that will development. the of at of innovation many With investors. relationships I'm filing. business growth. corporate, to to of And capitalized I with VBL She expected companies, a introduce to that, hand bring has biotech number enter ahead. potential leadership XXXX Bluebird Finger Chief Alison cash to proven Rice previously his will as we gene and and the potential year was in like quality would Bluebirds and Mike create excited and cell with and we Financial PFS Alison a help Sam and board. Chief Backenroth leadership capital finance, be and in operations, years Commercial Sam built nearly helping infrastructure expertise building of the quarter the I financial We Officer At in investor of Europe the added quarter fourth experience a and significantly where well with third catalysts and record new point, BLA has launches. biopharma Sam high are strategy, commercial strong to XXXX audience. momentum banking discuss in to we advance the into era over and also readout this emerging results. decades experience product Officer particular she as And pharma. value. U.S. Bio, please in into multiple markets VBL track IR head beyond therapy opportunities first our is of the XX runway three

everyone. good and Dror morning you Thank

and VBL VBL the to with to capitalize potential cutting inflammatory differentiated would by directors cancer company's of of tremendous and thrilled our be management like with and excited as U.S. of entire to points I help deep all, potential coming and to of patients say inflection My to team with build-up to we am VB-XXX. to begin to to and need of commercial cancer bring I'm team is of operations, of board with especially science commitment edge the people I raise coupled VBL's consistent and head the on What care. drew novel with therapies improve towards therapeutics. the of the how VBL's driven look First immune highly corporate forward culture biology some investors develop was at and I'm in I be me person months. to the preparing standard leading awareness a an team in appointment and with experienced you meeting launch impressed company's to significant disorders. XXXX ability for in the plan the understanding working in

financial on results. the to Now quarter third

short of proceeds we cash, totaling bank the XX bank equivalents, in cash As an restricted we $X.X warrant deposits deposits term XXXX million $XX.X September additional received from and had exercises. After quarter ended, million.

operating $X.X cash our expenses were in deposits quarter Revenues bank of the equivalents for period expect was for We in to fund be and third net term million to XXXX. $X third R&D of fourth sufficient will that the for requirements million and the as XXXX. expenses into quarter and compared the short $X.X capital as expenditure comparable compared same to quarter XXXX. million million the $X.X period cash

to quarter in third million the as the that call same for would share or comparable period For the for XXXX. back the to general and portion compared Thank $X.X to return was you. for $X.XX million this and $X.XX compared in $X.X the comprehensive or the $X.X share administrative morning's third to per expense the million per XXXX. quarter like question it answer And million finally, was for $X.X period in With call. of I ordinary loss basic operator

Thank you.

begin will question We and from now session. of [Operator Oppenheimer. Kevin comes DeGeeter answer go question Please Our Instructions] ahead. the first

with clinical us, with enrollment. on the guess we few a think overall for thanks of data about should PFS guess from I positive I timeline Hey, things congratulations the readout update. Dror the progress a CMC filing to, additional think should for the as relevant we future potential being about to we being is also BLA there step timeline think potential regulatory rate a about limiting that investments filing? or

are batches production know as ahead I laboratory preparing So And thank and was that time. used Kevin. question. commercial of you and release is actually also And clinical CMC trial have the you, used major reviewing in and therapy, were we all issue in approved but it a our that actually of the cell clinical issue, and know grade very of and own facility, know in times Israel as the test our agency gene good the it you already a were trial. the That's portion here the in we many facility

So I we well believe to the be result on work and actually a will on to are PFS, be a BLA doing good submitted with the a able in CMC that position and we quite actually including CMC. having

access regard with be any that year, for a pre-commercialization able guess that of are to enrollment from use or be next I continued then ovarian there early data perspective? access expanded VB-XXX to to, And Great. plans cancer could may completion helpful patient following compassionate gather program

working, that's should VB-XXX proof you hand. take of that that's phase always before the drug hint so is give good a and a Okay, concept a on the analysis need you one working although we the us interim ovarian proof is had full actually that in company also the but a good very II debate because have that's that

are endpoint On on second arm close we the that for VB-XXX to were the other we looking primary want is if hand actually the a that because you control survival. to know patient overall never they

be and on the believe until actually we will Program. we an that course, able are that because line result from with going all not are be hoped be to and to access able going such the talk plan of top long time the we then if top as the time positive been PFS we a I will that about recruited, fully we of be results line in that time is So to a expected, will start that,

but well remind overall study be on a BLA in the Although going might that go is the for we very will survival, position working are actually for I have also the the we is PFS to submitting survival. overall that because study and everybody

a actually at because making to patient. will we able this patient disease for an be access we now careful all to way. VB-XXX to it know, use as be a it these of this right actually bring actually enough to to standard compassionate new look drug change very in But and you are and a So hope way care deadly the is and as might patients program

thank you and progress your for taking Well, our on congratulations questions.

much very Kevin. you Thank

Our next of question comes from go Wainwright. H.C. ahead. Please Ramakanth Swayampakula

you. Good Sam. folks and Thank afternoon, aboard welcome

So DSM a couple to of first the is said patients as potentially quarter quick place would the the in review questions that from on all you have almost data you in me of from the trial. take expected

are indication and point, know let that are at going you what So that get going to review? to you sort of from investors

take data. the seeing data, is RK When are So the blended this DSMC only at full we population I'll the question. looking total

who see But it. each careful know is about the it. the not results don't of we So are we on We're endpoint, do we very talking but who. about

course, data. the all get after a of data they separate each hand, the compare data seeing on including primary the and the But clean endpoint the DSMC can not data group. queries. all other wasn't full is it's, It On where the actually the

be although line and results. until data patient going it's they the XXX%, will bit, get and a wait to clean little top be So we

tell never indicate guess us we green got the clean us they is should forward without and should trial stop my things a looking get data. up chance they But we up. to that that go if light, have course to might and they'll will cleaned So the expedite at of and we

DSMC just looking an just Yes somebody at the be whatever to that, we I add has story, you'd their forward. likely investor, very to results we've as that, and something the see very from and a what meeting, think importantly give regard to and moving in then to was high level disclosed would with their or to similar past, what disclosure perspective recommendation the the

it you. the then, VB-XXX. And year Thank as next on data Europe stated

should understand being and about to GBM, data up what it's expectations investigators. this from of run both in indications? be thinking cancer on groups by to but as And the sort them what So general, the are I colorectal independent these

who So as run and on the NCI RK, you doctors it trial, a know initiated or trial. when we is the the investigator all NCI depend

exactly say of that a to more couple to things. date expect. to difficult have it's So saying we the Having or ask thing say that I

‘XX when. we as and regarding is chemotherapy. saying different to we colon recurrent I'm GBM. system the investors, the And a as the A double a trial it bring first the has In on in patients but getting GBM, All a control, second can't radiation will to blind, is half trial already that's always immune a patients say the failed we're into just the we new in First, reminder, it All actually see of a The and has groups. and in three immune that before are with group surgery. adjuvant hopefully the colorectal, exactly whenever looking I of can VB-XXX surgery, as know I'm placebo the these if saying calls our their colon because point and system. meet goal

quite But second have they great they're a prognosis. going to So operation.

a new on surgery adjuvant as after later group then as The get first adjuvant. will VB-XXX

as VB-XXX. and group is new care. and new getting second The then standard the a group of getting And a placebo adjuvant third is placebo the adjuvant then as

is VB-XXX before is the of tissue So and of patient the are get getting tumor in the third surgery. this that the we idea we a trial

bring a not we will and that think we PFS overall that brain investigator opportunity we evidence immune the is on to When in and actually be a standard VB-XXX. we and time will that. be should have indeed at never who in but that's good is as see enough data. looking who know we're that because it So animal able human indication on the do is And trial care blinded of of genetic the six From think an to and patient the will getting of of as VB-XXX and summarize months, survival. models change to if GBM other and will being in cell have

the We will some with a come to at market results usually course presentation of the with these conference. clinical

Okay.

think do to need that you is FDA everything that do do trial right, if another for you and data go the to to goes file VB-XXX So enough to GBM? or

that randomized to we it's controlled trial wasn't in good phase it's trial that Okay. was a that agency was the trial. believe I planned, results a controlled trial, registration was a of the but when us the And GBM II big accelerate not The the got a trial. had give way it even issue successful, a because

we depends GBM, control of if trial And of the can with approval in here. So apply get efficacy disease, it it discuss evidence that of we for all it you strength where even for not, small will the in on we to deadly a show will data this will nothing have if or get will else accelerate course, agency. working, we the

Okay.

I VBL. know, So of one me. from focuses last oncology for question major one is the

you for and take commercialization? With the a start development how next seeking in development before of partner far the would year, this further VB-XXX study molecule

Yes.

Sam it's And question. great here. a that's So

be think think going trial you well monocytes, one specifically. which ability proof designing the get And cell first as us in is really address a we of go and clinical to seen. the have are that potential are that three therapeutics yet as both concept types monocytes in that the that implicated ahead can target don't inflammation, know I we're safety we really in remains human of to as to

applications that much probably allow proof So bringing it to think partner rheumatoid thinking I right some we time whether that's of potentially larger will that start that on the go us about once be that would to after make a have seen, like good with to arthritis, concept to partner. Crohn's will go at ulcer be diseases for believe point colitis, we whether would that strong but certainly us sense a it that's at would that remain that other MS or

Sam. to you Thank Talk Thanks you, soon. Dror.

you, Thank RK.

of ROTH go Our next Partners. ahead. question comes from Aschoff Jonathan Please Capital

at potentially Good PFS an the Sam. successful for be saying help Thanks. swiftly your us for file specific that you welcome something judge and would position OVAL to such perhaps currently you'd in morning, you're Can optimal prepare aboard, that doing commercialize and readout, optimism? VB-XXX be to guys PFS approval what more about

Yes.

all Jonathan, soon now a right ahead us And able doing results possible to great investing the So mentioned to right on CMC full Dror we're file we're enable really fronts we as we're as preparatory in to work once BLA be that's question. before, order steam have PFS the that as in and now.

a things ready to all to do pre-commercialization search Officer for positive Chief we Commercial that, be addition In do to to of really to conducting of the a are of then And in launch everything process for ultimately a PFS readout. reimbursement the market work, access, get the need ahead we and pricing, that hopefully a drug.

can will doing order that of everything file result to a and go ourselves are ahead we So that accelerate off prepare positive us to for PFS. allow in we and this a

Sam. very you much thank Okay,

Thanks, Jonathan.

Kreizman [Operator from Instructions] comes Research. Valore Our go Please next ahead. question of Jonathan

everyone. assuming exciting wishing in programs. leadership lifetime, the role want involvement year in rest this for the phase long the to and Amos you also of best develop the all and Sam. of VBL-XXX the and congratulate Congrats the Hi, Hi, for VBL's the long journey to

of noticed XXX instance, read moved on further. you. clinic some to a entering the expected ‘XX. in colorectal for So cancer you Maybe for to could study half Dror. second if initially you programs delays both have little end of and of the for congrats Question several of these the I of timelines some the out in reasons which for elaborate ‘XX the

are there was actually, know that issues COVID-XX. antibody a for reason. obvious now we are actually basically to shifted XXX. that ready are facing world a for commerce we chain the of of right except And lot There submitting was production make because effort concluding the a a And think pandemic. manufacturing the are towards of GMP a the for clinical the that's because what quite delayed with IND only of that with or it's an I pandemic. the of starting actually And issues the in in and place producing with we the think the of I bit vaccines a having trial the a

on just why in that's changing the is [men] having I'm are of that landscape in that in programming, a in have production we the track. now the we world. right And are it's we say nothing to now mention planning first to are that already And glad So change I XXXX. could the

far the as enough before, in period you not was NCI when we of As as when signal And clinical trial get a investigators results. NCI any a is patient, GBM before colorectal look share with don't having on these clinical will in you in an trials events longer biopsies it's saying come definitely the other we a we're clinical will And I study. a have course, that the result depend always is of us it colorectal actually summarize depends is study and to investigator I a with the from going and initiated market. this. But for the oncology time that we'll where on trial bad it we enough can it's the think and taking

Okay, great. Question for Sam.

act your that, share particular observations the upon hear if So besides with through points and intend medium in thoughts term. on as working you're company any the learning and you curve could short some which a to of of you or gaining Thanks. appreciate I'd familiarity to

in learning couple medicines. great spent genetic been question. because here, think, short no, has I my relatively I've years the Yes, last And curve

been execute six the basic at the least XXX investors say that the to I that So understanding with getting and now already and to for as weeks, across I'm to And or its far. talk learn program here working company you're incredibly set story disorders. and the therapeutics the up the both on very we've fantastic to that We've development application important side, together now is of so then continue I've different technology, and for be an and been the certainly looking on out really team on continuing data cutting really as VB-XXX year at inflammatory about there. understanding as well company goals my of second novel think I clinical clinic that has exciting there multiple will bring these we the possible. plan. about further soon starting been the elementary entering accelerate readouts able the edge both program. and patients to multiple to XXXX the drug programs, to and And really the come and And as

a I XXXX think here. great we're primed really for,

Thanks again. and luck good great. Okay,

Thank you.

question remarks. I session. company would and This answer conference for the like closing concludes over to the back to any turn the

day. us very on thank everybody have a Thank wonderful call today joining much. So and you for you

This concludes today's conference call.

your have for pleasant a You lines. disconnect day. and may Thank you participating