VBLT - Earnings call transcript Q2 2021

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Operator

Greetings. Welcome to VBL Therapeutics Second Quarter 2021 Financial Results and Update Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. [Operator Instructions] Please note, this conference is being recorded. the to turn VBL now will conference the over team. I you. Thank

begin. You may

Unidentified Company Representative

Amos corporate call everyone, Thank Chief quarter Therapeutics and VBL Financial the the on Investor press page of you. Officer. release Executive financial XXXX Leading vblrx.com. the and company's results available Ron, you was and issued is Good morning, website Officer; Chief company's at thank and for Dror be will Professor joining results today's financial earlier A of this update. morning Harats, Relations the second

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

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

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

Dror Harats

you, and morning, Eric, good everyone. Thank

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

survival were year's of upon and the to the endpoint to The primary Successfully FDA. a as either ovarian of XXXX. to III We and submission original in sufficient trial, clinical annual The remains the the accompanying most submission. June primary details readout meeting anticipated OVAL added has the half year of change second a the the second potential at end compared the press of readout Successful BLA continue point. expected Phase on release. endpoint agreed in overall in in survival progress original projections accelerate described make of overall progression-free based presentation be is this a VB-XXX the registration-enabling early significant was anticipated the quarter with to with the cancer. a BLA to ASCO meeting U.S. study event change was our support the the in OVAL Progression-free endpoint XXXX to approximately survival survival in one by which endpoint, meeting protocol

to the treatment time cancer. anticipated addition VB-XXX's as and implications shortening for positive OVAL the use for potential trial potentially protocol BLA changes In several submission, a ovarian have platinum-resistant the for the

we now as two will to to a that BLA. second First, obtain have a result trial including us on endpoint independent submit a shots the derisks goal enable

on the an overall Second, available show which benefit. not differentiate data overall currently ovarian to did endpoint, progression-free keeping and cancer approved from opportunity far survival VB-XXX were the treatment so based survival preserve survival

Controls U.S. study continue on VBL precautionary the protocol the are meantime, the batches on be voluntarily that OVAL new was enrollment regarding a we U.S. the do XXXX. Israel requested expectations half back supply their Japan. readout step will At when we the the paused an data group with this U.S. group, patients. from of CMC, Manufacturing for we and patients to would VB-XXX we agency Europe, the enrollment, in new agreed temporary of hear in and CMC the and As in FDA's FDA-approved pause the the June, all And the U.S. of the maintain part of PFS we them. Existing and batches in took used enrollment August, and it being data reserve who point, on of in additional OVAL estimated continues actively documentation data in materials enrolled our we provide the We the submitted U.S. the Chemistry study. in respect patients to to to in with U.S. our have In agency second evaluating treated not in early of timetable Despite discussion timing review. sent is

this next for reviews of time, the year. it study. OVAL Our XX% will is successful the quarter. expected about upcoming patients. This we three DSMC To study of review review date, February most have population, in DSMC of this milestone XXX one include that had was is recent of the The

to cover which hand. year-end OVAL in issued more until into the the These again company equity that of Following in the in BLA readouts first is patients, XXXX, ovarian quarter, mostly the potential quarter, of us a company proceed $XX.X DSMC we existing well as as we $XX from submission to the XXXX, expected as the second at existing at of the Together the and that shareholders Israel. In than funds our strengthened XXX to through injected million position. U.S. during now VB-XXX institutional gave million the public price million and are a funds the offering cash light additional looked market $XX.X closed we of Earlier in with were from proceeds warrants was raise net the which clinical the significantly planned. cancer. quarter, review, beyond the on green have also

changes commercialization for prepares of to VBL of had few VB-XXX, our As success Board a Directors. and potential we

in of cell health as execute has products to product welcome experience to critical be Michael was and VB-XXX Bio Finger experience global capital we at Commercial our Bluebird. from happy patients. including operational top to strategic as Bluebird Rice to care Board. and extensive Alison the plan commercialization bringing Chief in previously are and approach at of therapy our We Alison will the commercialization, disclosure we Officer to and markets OVAL objectives Michael's in line data VBL and gene

VBL of Bennett but was of Chairman the planned Finally, Marc our is recently a for our our to down now Vice stepped our Kozin, will October, Board. completed. contribute Chairmanship as Dr. last Board succession the member who as our joined Chairman. Board continue to as Chairman, Shapiro

half our are second optimistic that our the continued half this we the year. XXXX about to Before to I say Chief would momentum hand of of like and Financial the Amos have XXXX call into first I over Ron, Officer, from

programs investments through financial are VB-XXX, year. look We rest encouraged the sharing our for discuss forward you. I I who by second of that, the will With will on the Amos, off the of quarter. updates the and Thank the results hand to significant to call ongoing

Amos Ron

Dror, Thank good everyone. you, and morning,

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

Revenues second to be in million expenses period same million the share We $X.X compared Q&A fiscal our comparable expenses expect comparable XXXX. the will basic for in to the in $X.X for second per $XXX,XXX comprehensive period expenditure for million in year million $X.X the morning that capital $X.XX were for short-term $XXX,XXX in compared With compared and to Thank equivalents -- share was of to the quarter year-end will period as the to And you. for XXXX. million per XXXX. operator same until share compared quarter and expenses was to administrative $X.XX the I that, loss in call net or quarter and XXXX. requirements million R&D $X.X the cash bank $X the portion second for back this period $X.X call. XXXX. sufficient and turn operating the basic or fund the cash finally, was deposits in per General

Operator

Instructions] is first from [Operator Etzer with Please Darout Guggenheim. Our proceed. question

Etzer Darout

Great.

similarly, of guess, batches that glioblastoma if a study the study? by to And the that that the U.S. DSMC? is, update the of of respect the patients, pause of sort the in there's sort impact first the I Just the on guess on sort couple for the precautionary with VB-XXX. does quarter does sort third concerning I of nature of any change sort trial, investigator of

Dror Harats

have pause we we or to the we that that the at to States are in we the Thank position the position a were review, not supply are to the you, because new time, this will FDA the VB-XXX because DSMC we actually give screen this a took not to And we step the going patients are Actually, to quite batches want was was patient responding But these to drug some that trial review imagine trial, patients. approved a we voluntarily on the And And now amount patients. be screening, we Etzer. cutting not want is patients know using by of list they affect you that for in step. already for right United all voluntarily for that a DSMC therefore, long in don't that the United took know there a to to and going patients patient done to a and quite that the of if to new be recruit we when stop study. recruited X.X the a they in actually by is to affected mainly recruit that just that had patients staying any, can on are and centers they announce a to that significant was wanted States this. this

to XXX off bit is So patients, the population XX% a the about of going trial. review the of patient which is be over done

in that any supply with because what trial, cancer to to didn't that them go. trial. not we the affected because they for are know by were have is But GBM about in screening running new we for we're we not patients and just batches they in centers, a more colon before way also to need The we that other enough position Regarding running. trials for the have two we we in the want one open are the open we were this the approved NCI that event

for approval drug the GBM that Now back for it, post the for the will from the open trial. the CMC. already to recruitment able the moment the waiting final we and be OVAL will And is we in get U.S.,

Operator

Our Oppenheimer. next DeGreeter is with there question from Kevin

Susan Chor

This Susan Kevin. on is for

couple of questions. a Just

Is question. just rest to expected within year? R&D baseline? of the the last Is First, for step a modeling X.X million new the

Dror Harats

repeat Can you you the couldn't hear well. question? We

Susan Chor

Sorry.

for Let Is quarter me new the the for the R&D year? remainder the try of this spend again. baseline

Amos Ron

for in Are the the quarter? referring increase you R&D to expenses

Susan Chor

Yes.

Amos Ron

Yes.

Okay.

rate or run do year. continue we for this So the to not the full quarter expect current

will month per We rate of run expenses year. about less with R&D average million year expect our to a be or the bit be in last the in the quarter. not is than total gearing the for line advancing on $X evident a study the the was little VB-XXX. higher And And but portion oral in that because are we year, up, the

Susan Chor

question on follow-up VB-XXX A enrollment.

Can in patients. the update of So XXX guys you you enrolled June, provide I an enrolled? think had patients on number

Dror Harats

provide get it basis. to don't provide significant numbers. Usually, we regular a when on We it we

now, I right we would number So prefer on the keep progressing. not say to but

course, in screening the Of are we not now U.S.

able we or pace by the if the will of next but slower, line recruiting time year-end bit with be we a meet things the beginning we year. well will CMC, of can So work actually that believe finished -- is to

Susan Chor

any last one process? inspection is just follow-up provide kind the that on-site is, lines? delay guidance to Great. question. that time there I Did my And of on the FDA guess any And review might

Dror Harats

inspection. expect No. We don't on-site any

BLA. the that the You is when coming usually, inspection on-site you know submit

come all for that it's time in on sending done wanted There data and The reason potential was before shortening they know right they of And them. us it guided FDA FDA we beginning they actually course, -- of step. see in back We the because at will to that I are they a send moment the are at now sending that we've And the working know what status information, documentation. believe we the one our them were review the submit reviewing on-site to and the we exactly is of it believe Of information we this BLA, BLA, it. and them been in that we that month. all the case, will lot that visit. is us we no on the assured this need thoroughly to are that but quite

Susan Chor

That's the from all questions us.

Operator

question next Wainwright. RK Our H.C. from Please is with proceed.

Ramakanth Swayampakula

you enrollment, the Dror regarding you're impact Amos, population commentary statistics study. terms the precautionary final analysis mix and have a of U.S. -- potential you on the when do in of the what in the get or that to if oral the on side do is taking pause you on there

Dror Harats

that I either an U.S. overall of don't or a When think this the question, it I the we good will have from very but the the statistics majority we think patients had -- step, don't that's population. took on effect already coming

So from and anyway. FDA where that issue there that of thing that of will won't want they know be the that's majority to part coming the majority patients of the the an know from you see because patients the U.S. coming of

real patients The pace we as second of just that change big I thing amount screened. the was quite no recruitment saying before before, were is this that there in is significant of had because pause,

And was fully plan better than we XXXX. So time all time be we saying was, knew recruited recruiting year-end. all we our by anticipated, were assuming the statistical the that quarter will our because that we first are plan of --

So I the change think of any the or will will population we if will it statistics don't of change mix any have. of that it

Ramakanth Swayampakula

And drug on enough long the then U.S., these in that drug of case recruited is the patients in people to already than for of for need the life longer you've stay shelf anticipated? the some the

Dror Harats

and was we have no we now, with issue. I Shelf the years. X.X%, no way, That's And shelf a life extending by it are production. life. long we recall that it's we and right, X I now issue right life, but for with VB-XXX, have issue it very shelf believe any have have we don't if about

be looks making are batches more the for all and the already commercial batches some will We batches well. and of very

release comparable to of was are So the that only lab was it the showing issue site. new the what in actually the and done facility other

Ramakanth Swayampakula

update studies on the cancer the GBM at any time last My in on recurrent progress? and data colorectal terms expectations? And all is in of the the any question of lines commentary also terms

Amos Ron

at as planned. you are tumor lot cancer meaning all colon cells. the we we colon look know, doctors CDX the tumor, continue to if Institute agreed see have biopsies is that National into that inflammation turning a we So the with of a the off hot -- and And there indeed CDX we actually as cold Cancer will and

that, are For where enough on and patients on when they the need combined therapy. are we biopsies VB-XXX alone

advanced of patients and quite market. at enough And course, imagine, more have I data will takes we that's and signal, trial collecting have share it for bad As histology, that's a is information And on enough with like will disease. are that don't that you think on can the this that. but that biopsies it patients are going we ongoing NCI and that the point the we in their moment it have point we The about the study time. don't I that. the will

the trials, that the centers Regarding are But open, approved are of GBM is some use use patients in are sake agency on except didn't the want for for to sure that material the OVAL for have drug, on clinical we because trial supply are VB-XXX amount them. and a have that patients for of patients are significant any getting we make U.S. enough to that the trial, actually on and centers some any already ready the the trial, for OVAL by of to the that again, open. the there the trial, to we are

Operator

Roy [Operator Instructions] with is from proceed. Jones question Our Soumit next Trading. Please

Soumit Roy

progress. the on Congrats

U.S. what how you percent from U.S.? And us patients and If second U.S. many could ex is, the ex is possibility patients a give if that's a little if are post you have redosing on relapse? patient, color treatment just a versus on what versus And kind would it are stable there sites U.S. of they idea of -- the of if sense? undergo any makes mechanistically, -- what

Dror Harats

Yes.

question. So thank have In you, patients over the for out these do patients. of U.S. the we XXX XXX Sumit,

XX There alone. sites So about the are the it. U.S. U.S. about from majority are There question is no in the coming

about U.S. from imagine. can we coming the sites So as you you are talking of majority

from sites also the was question? have beginning your second the Japan in in patients was number We majority of but to U.S. study planned significant a Europe, of What and the the from in Israel, have

Soumit Roy

patients allow? Does -- able not disease development something these to it redose of make antibody patients? sense be because for that's vector or to you mechanistically Or stable won't

Dror Harats

and from prevent quite does No, get the drug models not chance is the it when of for is could it the a about recurrent gene protected the antibodies significant no. time. of time, had both tumors. to the the working The takes showed very in human quite and period of responses they the long actually being in a and cycles biopsy long drug few dosing. we of Actually, cells from in we endothelial to see into for a in because animal expression there drug we a period stay blood And and

question to a patient OVAL actually and not X every And no is that colon And give X until sure the progression. it real there treat we why the giving we beyond every So weeks. to weeks treating trial progression are pseudo this recurrent every progression. actually, progression allow And drug is not X in weeks, study, are until you the we're that's we dosing. that in can in the

progressed. OVAL the trial. the So part system the it the checkpoint because that When one restart But maybe at trial colon inhibition inhibitors of not the there in be control the it or we giving tumor we working. combined they study It NCI, checkpoint progress cannot we with it's that -- inhibitors. given where But induce we of I think theoretically immune of by there. a what would it then is drug the the brought patient dosing part is repeated because the the checkpoint are progressed, as until of patient is should that reasons theoretically,

as they them So go to ask a of if is chemotherapy, patient put as me cancer. but know, doctors you the there try what no the sometime treatment platinum-resistant when do they for ovarian far real progress, on I radiation,

Soumit Roy

progress. Congrats on the

Dror Harats

much. Thank you very

Operator

our This question-and-answer turn does VBL conference back conclude comments. the to to closing I like would session. over for the team

Dror Harats

all us a thank for on today's wonderful Thank and So you. call, you day. joining have

Operator

does conclude Thank you. This today's conference.

your time. your you disconnect at for this may participation. lines And thank You

Notable Labs (NTBLQ) 16 Aug 212021 Q2 Earnings call transcript