VBLT - Earnings call transcript Q2 2020

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Operator

Greetings and welcome to the VBL Therapeutics Second Quarter 2020 Earnings Conference Call. [Operator Instructions].

As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Michael Wood of LifeSci Advisors. Please go ahead, sir.

Michael Wood

Operator. you, Thank thank quarter and VBL for in participating Good results you and second XXXX for corporate today's morning, all update Therapeutics. call CEO Amos call Professor the will of Harats, the Leading company; the Ron, today and company's CFO. Dror be results the release at available financial press X:XX became A with a.m. page today and Investors found website company's on be Time the at Eastern the can of vblrx.com.

these safe to prospects harbor remarks about purposes plans as forward-looking and differ constitute Before that Securities statements materially subjects Act today's various August Thursday, of of conference statements under risks to could indicated. Litigation we future those and today's of Any cautions provisions that forward-looking the begin, the Private date, that's statements XXXX. remind uncertainties everyone are XXXX. I'd the from that made the XX, results forward-looking like for only cause speak Reform actual on of expectations, VBL call

to events after forward-looking not these update does of company date. today's circumstances the or intend And any reflect that to statements occur

a company's being available on the rebroadcast and audio for it will the be As call [Operator recorded conference Instructions]. webcast. is reminder,

please with ahead. like that, the Dror, turn over Professor So Harats, VBL. of to to CEO call I'd go

Dror Harats

you, and morning, good Thank Michael, everyone.

Amos is who XXXX financial call today's our the results. on second me Chief Financial Officer, Ron, discuss Joining will quarter

progress achieved. We company have made midpoint past we and for the milestones the happy are we with the just are so now the year, very and the far

first monoclonal filing. continued VB-XXX is evaluating programs forward, the our with clinical move IND antibodies Our and work advancing toward to MOSPDX

equity X the strengthened the our completion with financing. of also sheet during quarter We balance successful

platinum-resistant cancer. is our an investigating Phase Let VB-XXX III OVAL update with study, on me which ovarian in begin

chemotherapy. in stages stage. line each the data, platinum-based worst disease-free who with asymptomatic United most advanced first-line Unfortunately, a in characterized early ultimately and shorter States. mortality. cancer is surgery outcome remission with cancer therapy According disease is the will frequently XXXX, advanced and chemotherapy were reported women is as subsequent Ovarian ovarian achieved patients living NIH of of a disease. The are the high there are cancer platinum-resistant in silent disease Treatment with patients XXX,XXX over detected Ovarian for the include official with usually in intervals. killer by the to recurrent develop patients

goal of spite those insufficient in therapies In show is benefit translated OVAL survival are III of the as ovarian survival patients. that This advanced been survival our This study being collaboration of is patient has designed the extend in in conducted substantial quality double-blind study. vast GOG There overall the therapies of Foundation. of with majority investment controlled OVAL huge resources, a are with current Phase its primary with benefit platinum-resistant into is exactly disease. potential to registration need good of particularly and for cancer can life, unmet not recurring endpoint.

analysis signal goal the March, a interim ASCO The replicated be see cancer was a a was of to in seen is an Committee, that independent study and randomized, Data this analysis, or presentation Earlier in the of study featured the Safety conference early positive in double-blind, an this ovarian could efficacy the DSMC, Phase in of the our in placebo-controlled of outcome conducted in study in trial. II was stage at OVAL June. Monitoring

control the were arm. was the this fourth time. the -- VB-XXX very at or analysis DSMC XXXX, futility. encouraging. patients, The The demonstrated unblinded in XX% arm The rate post-treatment This over independent review. interim treatment XXX with advantage is -- frequently the that the which the overseeing most or followed trial the up of and treatment, first VB-XXX observed response with even was absolute arms took fever, in completed with higher, XX%, ahead which are for an second after response pleased we a that was week, in patient preplanned quarter the second in rate the XX% is higher It treatment at to looked least The it successful. higher of was from assessed of X analysis occur analysis projected place X data for an which overall months survival and percentage initially

planned. The survival overall reduce data company blindly OVAL recall, has control endpoint groups trial trial study. you combined. continue treatment As in primary that that participants, committee all the RA and the in as of When the recommended is the is the

response high This observe the evaluable as of a well. encouraging course, total XX% rate We is, continue rate of of patients. over to response high

additional Recruitment in VB-XXX we are pandemic. geographies. Overall, currently well is the the development projection line in proceeding and the slightly to COVID-XX the better. OVAL with recruitment of our trial further ready Still of OVAL to spite of even expand pace initial expedite the study to in is getting

The We as periodic DSMC OVAL advances. the study planned on expected XXXX. of OVAL the next should in update additional study quarter is in provide as review first

the thank and advance their as well families this potential patient the Ovarian and as the all are taking part We in cancer important care benefit ongoing would and who patients VB-XXX for of excited professionals investigators are to study. health like to

MOSPDX our program. to now Turning

cell identified drug potential regulatory which for target we development two of as We and key as and are programs the parallel that MOSPDX, cancer. a a exploring of motility inflammatory a protein, therapeutic diseases are conducting

our targeting for inflammatory towards have VB-XXX medications, are treatment and of antibodies advancing IND. various proprietary we MOSPDX potential elite candidate, Our

we the June, which pre-IND under a In application by for FDA, the submitted is currently agency. review

XXXX disease study the inflammatory in first-in-man disease, start new fourth XXXX. rheumatoid and EULAR inflammatory toxicology the to on presented -- our MOSPDX potential We studies data treatment arthritis. at meeting we the of a An expected in antibodies is quarter in of as of use XXXX expect anti

XX% inhibited and disease in than the the more blocked The showed progression. antibodies disease collagen significantly anti-MOSPDX severity of with induced arthritis. progression further We by treatment arthritis reduced treatment model

higher the MOSPDX data classical alpha, preclinical scene America. as anti-TNF activity X the advanced results therapy the phase Importantly, disease. in market crime in in in disease, beyond on billion $XX a date the a go with of than the human to Actually, anti-MOSPD demonstrated market our

biopsy that clinical MOSPDX strong of supportive from the joint, RA the in is showed staining evidence inflamed for is patients in another RA. for We MOSPDX which relevance taken show

Our NASH data in RA a add additional to we and DDW, Disease as or presented colitis meeting. findings Week, in Digestive XXXX

selected the In of was of a this in abstract all distinction. XX% study rated was poster and category that in as top

manner kill antibodies, cell a program resulted MOSPDX T in oncology, cells activation significant also that we a meeting in our the target at In antibodies by studying a recent we the MOSPDX fibrosis a show data treatment cancers. preclinical bispecific reduced colitis session in activity in and mediated animals The were program results with treatment on induced with established in shows are the in T expression disease model. from metastatic presented our of a inflammation statistically in Our in in to antibodies virtual in improvement CDX administrated that decrease dose-dependent and killing the We aim late-breaking survival. anti-MOSPDX significantly tumor cells cells. model cervical data to tumors. from antibodies antibodies AACR study June. breast this and the showed our vivo. which multiple and whose tumor that had The of NASH established Having most in data were bio-specific type The as induced is second

To progress made our MOSPDX? summarize, will VB-XXX as as updates both keep in see, quick you can and informed significant been up. additional We programs, you has come

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

Amos Ron

second and related were development by was in mainly expenses in to for expense. MOSPDX net for decrease the the Thank -- a of IAA net you, second second development research in the the XXXX. for XXXX to offset million costs XXXX. the shown in General expenses grant, The million the $X.X IAA $X.X increase the $XXX,XXX quarter expenses payroll-related were development compared share-based $X.X comparable mainly in for grants. approximately and $X.X to are period the expenses compared Revenues of period for XXXX. were activity approximately the million quarter compensation administrative is for the Dror. comparable second compared and second in and Research $XXX,XXX Research and quarter quarter net million to increase quarter

compared primarily attributable was XXXX. $X.X for for quarter currency Financial was second second net for $X.XX decrease the $X.X XXXX or for per million the the compared unfavorable loss exchange in of the with $XXX,XXX approximately share the The $X,XXX changes to was per second approximately million income to $X.XX in XXXX. quarter quarter Comprehensive or share quarter rates. second

restricted $XX.X and XXXX, of and As bank working deposits equivalents, deposits cash cash of bank had and short-term June million. of $XX.X million XX, capital we

completed we enhanced equity Our the during proceeds million. in Net approximately by was that $X.X were second financings May. quarter cash position

short-term and operations our XX be the bank that deposits at and -- and requirements XXXX. expenditure expect cash us quarter into We of capital cash our to June will third fund equivalents sufficient

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

questions. open We will now call the to

Operator

[Operator Instructions].

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

Kevin DeGeeter

the from really assessment the first the XXXX? OVAL. today. of encouraging on triggers A Congrats you in to us quarter Dror, remind interim update on next me questions few can as what

Dror Harats

registration short of And a it's trial, are course, it's because actually, we a So patients. about and XXX not trial. talking

at meet, a an but X DSMC, will the not study, only on some year. them regularly of mean time to they that meet, very is results, the reason months, whole DSMC a also we'll safety detailed look -- they or unblinded for they're unless fashion are every looking safety course, endpoint. there every which, on an urgent getting twice meet that Each So at so

one they this they it the in was survival first first CA-XXX. if futility, So for safety the the was with rate, because In overall for one at of for was at looked looked efficacy, analysis, preplanned, mainly interim response this patients. the interim and analysis,

end From they the and all they go time plan, we are course, any to results, they is signal time. the and as of is should going any And get any each trial alarm for an of there always there the we both or look result major safety of or safety And if then, ethical course, at this or at to issue. if of according efficacy. if will for the is will there of if us now on, are guide reasons efficacy

actually the guide patients from meet, they're months which people, any do every go to therefore, with If should is as we convene committee, X keep with the GOG modification. and and should steering And treating see their without mainly us going you if trial sponsor placebo. on efficacy, built you

Kevin DeGeeter

sites of remind I Terrific. open? your the Can of X And of open things. many target then you general perhaps And you terms to think geographies do currently effort how two, expand with One, geographies regard And mentioned to months? in sites. perhaps thought to sites number the and the coming us in as number well. are process

Dror Harats

So both to are all are the right to centers get XX I Don't centers might we, traveling And opening have me centers. they in States. having And be all to are XX get actually, Israel or planning the the but and that believe, we almost now, on It number. centers exact have it. in the although, to open we get we recruitment. patient for COVID-XX need United VB-XXX the XX, where

The to extension encouraging. quite and to Europe do reasons it's good Japan. So are to mainly There is it. X geography

the the for expedite in that and issues, second regulatory to going And Europe actually patients. to time course, in thing of we is, both Japan. recruit First, are

really previously, both to we also, didn't working the it -- tell when Europe actually Because can Japan. better. due and the we And quite elected COVID-XX, it same right or we open was now, But I and are in Europe to not the on that in pandemic Japan. of you start

recruitment. our the bit on a We ahead are of actually plan

Kevin DeGeeter

Do Perfect. XXX, into sense? maybe me, may. development make And to and if Phase might healthy one clinical really for population you populations or kind volunteers positive a hear then what active in program regard potential the in patient I the a patient latter, XXXX. one anticipate the with if I to disease just last With path of

Dror Harats

So this issue. we debating are still

It's patients. You there I'm is all to not -- And and go today now. that complicated. an option right bit that's to I more a that believe know is directly committing

also much We and doesn't to our what monocytes. XXX vivo, to our take doing vivo but function, to will immune not which a affect the evidence like so And be volunteer with will antibody as a understanding human even but anything go hopefully, we we any course, far doesn't we would study volunteer monocytes more pick function doing And is healthy in study, data immune system the histology. the to easiest studies see ex short start in T cells it on was is it antibody show actually in start know I on human Phase have or because B the normal before way thing and to is to we It indication that healthy that And to to a migration, being. first working and the much from but way, in having will mentioning, just up. some right in the all to system. do of of we in better humans now cells, the where the it healthy healthy then we monoclonal will go I, in that is starting they idea volunteers the were deeper study

Operator

question comes line next from with of Partners. Our Jonathan Capital Aschoff ROTH the

Jonathan Aschoff

groups is second the that progressing modification? without minimum wondering, was I And between success delta interim required survival progress. the on a was what for Congrats the

Dror Harats

it's excellent all study, already is to patients, it's early of very public we although, domain. have follow-up. you we this X only question, This in an for understand Jonathan, are But patients, but XXX in not analysis months that the X/X the recruited talking and the

and mainly safety was So futility. for it

efficacy. the and anybody want meaningful at of at already probably long to a will is It the now, DSMC most going and efficacy that point. look about survival from of X signals that data the months next follow-up the look more, don't patients I in look to they call. about I early first too have of anything or to at be will this at very where will to time time So the make XXX them some believe

you we without or The the don't of we modification us actually forward -- they and we it, minor tell that the with that therefore, any only And mention told disclose can didn't want any to study. I go numbers. thing major can

Jonathan Aschoff

for equal than no for right? minimum Okay. was or greater triggered interim, XXX And death X that to requirement second least then solely months at by whatsoever had and patients number,

Dror Harats

Yes.

Jonathan Aschoff

like that assume had information any I that get patients you right? blinded that, did nothing survival fever, not Can in regarding a

Dror Harats

not. Of course,

Yes, data about on and data completely We are we see. your blinded is on. a do you not from the the something data, get. survival. everything going as blinded data. going recommendation. misunderstand data right on registration We that talk wanted We information question. see get we I the actually response to do of it blinded This get DSMB the now unblinded we do data now Blinded We blinded know, because, to do is on Are blinded any course, blinded CRF rate. is is do or separate data? we to from the get DSMC

any So clear it data DSMC didn't to unblinded that be everybody disclose the us. to will

quite study. mentioned response So have rate always other only on the it's data, we talk on risky to information more today, about data. when blinded I of thing the endpoints the talked the blinded of I about course, But

Jonathan Aschoff

Okay.

rate specify, and but XX%." I you're that a resist referring CA-XXX still "over assume So referring maintenance not You to were can response high criteria? to of when you the didn't

Dror Harats

over rate before. about also the it, to But in XX%, that's what near CA-XXX take resist well. I will future. the say, And seeing we're disclosed as talk talk would it opportunity we I the because When response about was we

Jonathan Aschoff

Okay.

or are a do timing and nature GBM initiations, IST difficult for because the you is the that they of the that? the very handle still -- just on Lastly, colorectal have

Dror Harats

have times, there although And on deferred completely, imagine it's you really first when actually, team, but we simple. of patient in team. will to optimistic. start So it's the the studies, I it. prefer not announce we talk not that really And patient But we're first we can pandemic, even the that's about But middle the have track the it will are in we when to study both many here. case

Operator

Instructions]. [Operator

of next Wainwright. Swayampakula Our with line question comes the from H.C. Ramakanth

Dror Harats

RK?

Swayampakula Ramakanth

couple the apologize. geographies other for certain In mentioned a expanding. remarks, that, expanding geographies? Could about too. been there's trial. has increasing -- ones. if and registration something I'm little the for for more been strategy bit for I the purposes behind if Is the you quick going into calls comment a on I've the apologize ask you it what -- I between study additional Or into A shunting to is it? or answered, already which of need OVAL your

Dror Harats

going it, it's when was registration. very is we the recruitment recruitment both expedite recruitment, course, Right do the the So trial good important But and very decided reason, it and and a well. for will to of it actually, very a for for good nevertheless, for registration. now, I think for getting the meeting timeline,

in our reasons mind. both have we So

Swayampakula Ramakanth

preclinical programs. programs? you clinical do MOSPDX this before you your Phase then designing the regarding your And additional or to At can do need programs start what point, work I

Dror Harats

So actually have the meetings X whoever familiar of antibody a with development, always agency. you monoclonal with regulation

is The to for we the clinical synopsis have pre-IND submitted submit and the that you have, want meeting, and of a where your first type already Phase to development one trial to actually you to what outline, I them agency. already

of we what a Phase want lot I to we want So have already to the about in do what do and later details we on.

at Of exact the toxicology. -- your what is second to is And submit you toxicology depends plan. course, the the point thing dosing have this is to agency on

you it will not then skip might meeting, you if You can IND to this but that you an think agency be think won't studies. or want, pre-clinical meeting, significantly enough actually come the had and that or toxicology

plan the the that fourth think program it's from agency. to disclose saying toxicology will quarter, what in I get is But an the will in We know whole the they quarter. upcoming about the them. under already official everything it. I we the to submitted when start review. already we But was mood, response So the

see it what report toxicology line of agency. the then for submit already can when thing the toxicology. going we of result imagine got to won't the But most to be when And get the So that's the we the you and the you they that materials they you are planned. can everything done, because with IND the see first basically time whole they in the are except IND, that that in

Swayampakula Ramakanth

me happening question -- program much the The European for veterinary Okay. you use. on status How on publicly last can much with the what's from collaborator? there? that of XXX is within What's disclose how

Dror Harats

Okay.

starting a already did the because clinical animal, it's I in we milestones they before, was you -- small of trial the program. on the done And the recall you tell I with of States. can this X it the, that But met have important trials vet one we molecules being. COVID-XX. in all So the and one already postponed in vet believe, the going we companies, on that one actually going start that and in deal COVID-XX, trials, the because of universities big of of was or of It's not And be very to right actually it's soon. United is human to now, I saying

a things hopefully, there but progress was very little will now delay, So quickly.

Operator

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

Jonathan Kreizman

the on OVAL around Congrats trial. developments the

I have So a around question or two MOSPDX.

timelines to options? maybe are around and You share realistic of some And are approach series today. and include advancement any clinic How of would the you It these some published current you you we you presented of think environment? whether plan expect the what could steps programs? and the next papers if considering prioritization helpful some achieved considerable thoughts preclinical these could should a be commercial have for some

Dror Harats

Okay.

for So the you Jonathan, thank question.

basically most we do a the will expecting disclose coming I toxicology, the the able get good. agency, believe terms on And going Otherwise, sign will goes to always the in have is with which soon. present well, that of one be we we also if stages that's issues that multiple next be to far to to In course, conference discussion MOSPDX, the first because toxicology, more market. of that's going towards thing program. we see we sclerosis should the going very be be, about is There in are where very good toxicology, But quite The are milestone of to be and a program important data might to important if the of in this and X milestones keep the with we what market have course, are you so will the rethink reassure If our important an there coming. to soon. everything toxicology, on it.

believe more X, human going there have MOSPD to key just hopefully are And about I it beings. activity we to in and present are this just little evidence opinion And that going relatively what this, in some present that do RA. see to it's actually believe to XX% even flattened hopefully, can In in about almost a inflammation. we'll the have major all is event, important I or these was activity about and the the we in anti-TNF animal developing of talking chronicity But then are get. so maybe if bit leader the even role a animal animal I XX%, why actually emphasize to the monocytes And public, a the want it things when to with about more soon, data. program get start progresses, MOSPDX also will related of saying unique monoclonal disease, and but models, today just I you or not on all have play actually we of vein to the alpha, inflammation. give subside But models, And when the then disease it's diseases a antibodies, even It's up working pathway you you down diseases. But because these can maximum chronic opposite. in actually on response. the a completely models, it.

the next the are doing are And year, that some with study with toxicology. in course, vivo the preclinical with ex of going in that more to both human we come then, So results IND. I believe we

Jonathan Kreizman

thoughts -- around into next Right. you just any which out would several the prioritization, there. year? earlier ones expect again, of on And clinic have Any progress these you programs

Dror Harats

an in first going we go which to we the And what bispecific. VB-XXX, terms of Bispecific, to at definitely in program. is it's there option the that different the to and IIb, as all be first Phase and is the which and up aimed that sclerosis will the are going program look is I whole is not inflammation, a toxicology there for terms first, multiple actually indication. Phase much are in know, of the But more and believe no pick agency complicated picking. program the is I indication we to as IIa regulation, we

are deferring this So decision right now. we

can is decision you we of from whenever say, of imagine, our market. I completely As come with anti-inflammatory where different interest, on the, go. discussion the more programs exactly results, do other to of questions, course, this We program get would and part and any one

many huge Of is in relatively partner proof-of-concept course, is where different going indeed actually is inflammatory get what in that be indications, it's need, terms option of if this is a it's easily? where working you Because to of here. need And can program. a a trial there shape market there the is a achieve strategic to

Operator

We closing have this to at floor the over management for questions turn no further like would now comments. back to time. I

Dror Harats

our So for participating hectic time. call all you safe keep thank this much. in in today very very Thank you and

Operator

teleconference. this gentlemen, and does Ladies conclude today's

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

Notable Labs (NTBLQ) 13 Aug 202020 Q2 Earnings call transcript