Notable Labs (NTBLQ) 16 Nov 202020 Q3 Earnings call transcript

Greetings. Welcome to VBL Therapeutics Third Quarter 2020 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] Please note this conference is being recorded. to LifeSci the Advisors. like host, to now Wood, Michael would turn conference over your I Thank you.

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Thank you, the became Corporate Operator. participating Good vblrx.com. Harats, this company's morning on and thank morning this Professor and be Third be Therapeutics. the Dror XXXX morning VBL will in found Ron, of VBL you, Quarter Results press with earlier for and and Update CEO Leading call today's all, the Amos at the available release Investor's company's page or the A CFO. company's website financial results for can

Reform as like made forward-looking and Before November occur forward-looking could conference Safe of we the date. not reflect statements call uncertainties that cause cautions today's begin, indicated. risks various remind company these the update those actual statements XXXX. I'd intend only constitute the plans circumstances for to or Harbor expectations, provisions events Any to today's about after the VBL and forward-looking Act from does results prospects subject to differ forward-looking remarks of Litigation these that future any today's under on XXXX materially of that and are the of purposes of everyone Securities date, statements statements to speak that XX, Monday, Private

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

brief be go the Harats, I'd mentioned, Professor As session that, call VBL. a There'll operator all the the Q&A of Please to mode. company's in participants CEO over currently turn remarks. listen-only following are to like With ahead. prepared a

everyone. morning, and Michael, you, Thank good

it VBL's to our for am with VB-XXX, important the gene will XXXX quarter me VBL financial solid milestones our another and results. for that unique on quarter third Ron, pleased Chief Officer for Financial who tumors. today's has productive discuss Joining is developments program, call of lead I say been Amos therapy

treatment patients OVAL on top setting of of with upon to likely with XX%. study the in receive were presented higher. is or population. an has in ovarian of response viral-based rate Such was XXX analysis enrolled, dozing. of Data pivotal Phase be study The currently flu-like trial is of VB-XXX encouraging. that at standard The VB-XXX COVID-XX the ongoing OVAL post and has to therapy are XX% for which the induce OVAL to patient on standard has the American which of is rate enroll projection. for endpoint the randomized for to condition. in is recruitment the There study with rate the challenging survival. overall initial this demonstrated treatment is response XX% response and successful, a Clinical XX% the are patients VB-XXX gene response weekly was higher, up study primary pre-specified treatment higher first Oncology This between the fever, or potential the are chemotherapy. Monitoring placebo-controlled conducted symptoms where in been standard our encouraged typically expected conference Phase we than designed particularly options. potential Paclitaxel, VB-XXX year, Safety the adult pandemic, now that now care are results XXX which proceeded care announced the cancer, of a of disease June. their placebo is which of progress in is Committee Society new double-blind is to Despite We which have registration and in are ovarian DCMC X our Earlier arm, this In recurrent XX course treatments rate recruitment arm by impressively care being even is a platinum-resistant the either which a expected cancer. X can independent limited that on which Patients projected the or is was international patients proceeding by symptoms almost anti-cancer outcome half pace interim not well enrolled, patients chemotherapy establish

is note it see available continue blinded, the XX%, that study by patients today. pleased to While remained patient important enrolled the the XXX over which close high response we total with we steady exceptionally population to to are rate in

periodic advance first well As the review you place see, the to of overdrive can next scheduled is DSMC and to in continues the quarter take XXXX.

agreement study, checkpoint reason inhibitor nivolumab, cancer. an investigator-sponsored for There Dana-Farber be X GBM, which that Cancer the general, a The with being to recurrent approaches cancer induce initiation this goal where for immunogenic. is CRADA with followed explanation investigate the to are is Center developmental cancer VBL. appears and that X a between cancer conducted to in combination study gastrointestinal Colon is GI, U.S. but may anti-cancer centers plans unsuccessful. of VB-XXX of immune common the National and announced in VB-XXX Institute with so the VB-XXX, under a is metastatic most immune-based leading it VB-XXX nivolumab the have by less is mostly The one Cancer patient Phase we One worldwide, evaluating Phase priming of response. been of of in with other Another possible also addition initiate neuro-oncology was far, an immune an colorectal study

the we plan plan also the monoclonal first to are program. antibody important with immune clinical inflammatory We In therapeutic to candidate a our progress meeting held an MOSPDX VB-XXX, when we indications. we September, development be alignment FDA. for will milestone for take forward making reached with pre-IND which excellent We reach on

through IND-enabling aiming the XXXX. studies in We an submit half advancing currently VB-XXX application are IND to of second

Bernard stepped our will announce Board. to the role Board. Vice Finally, Dr. as but transition our Kozin Shapiro, time, serve XXXX, in excited Chairman, of were during on at which the was appointment of will Marc to to continue of October, Chairman we Mr. current Kozin the Chairman down

has As areas can who a becoming stage. organization toward help to members company success, guiding for commercial the it next expertise and important prepare is of Mr. we with to the have Board advance with appropriate track through decades three record exceptional experience companies. Royalty of know biotech him HealthCare association Many and his consulting of helping and industry has Partners of will Kozin you LEK. an and

quarter. to have We important are for take role. on thrilled call the will the results this turn to Ron, him over financial our review Amos the now to Amos? I CFO,

XXXX. $X.X Dror. $XXX,XXX quarter, the in to Revenues net third for expenses loss to million General you, share XXXX third XXX%. Research compared quarter for quarter $X.X the for for comparative quarter XXXX. were third third an of million administrative $X.X approximately $X.XX million approximately period compared for of increase Development million the the quarter for Comprehensive third expenses compared $X.X Thank was or for or million, million $X.X per of comparable per XXXX, $XX,XXX third the period XXXX. quarter share and $X.XX with in the were the $X.X compared were to

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

into cash fund bank the operating that and to expect deposits requirements and XXXX. sufficient be our expenditure capital third expenses and will quarter of equivalents cash We

call. With X-K Q&A refer this with for please details return For the financials, filed form the operator on of SEC. to our afternoon's portion I to things that, further the back

DeGeeter Oppenheimer. [Operator proceed. from Instructions] Our is you. first Thank with Please Kevin question

you in Okay, cited provide great. comments, Dror, OVAL. about exact rate with for in all prepared and a regard us the patients pooled figure point taking patients. believe a two you estimate today our number the to from your Thank I of for on response really, guess my today. response congratulations for maybe and questions you, OVAL enrollment progress from I that XXX on? questions of based Can rate XX% that's first the

of if about [ph] you And at that we did that's patients of for talk or is Yes, patient least the we that Kevin. we is XX% real what at response. not about Thank trial. we a know this It's have a patients so we in analysis response about two [ph] follow level, know, to of the twice XX% actually the course, as CA-XXX, are of the up patient, of you, real talking interim a least and When that can XX. a available have course. normal which exactly all about recruited talk months we

was response now can and they're from I the can in higher So that rate for which but don't number want a a XXX about, XXX a number, XX tell population, talking we've XX% seen I total this is patients bit not patients. you give what but it's exact actually I the estimate. around of is one far to first above already even you right

can and to trial a response response a it's that this high very actually So this for are see so we this trial, have that trial, recruiting basically conclude rate do going rate. are very we we at in we steady, higher halfway now

of Now, is see have nicely course the from would patients of response about analysis why we now and I blinded we so very the a still blinded went the if to rate. what do quite can high already it in know trial favor what but talk population, same interim to VB-XXX is that change we this moved we the XX that total XXX, that from

this really encouraging. So is

the maybe the And DSMB two to regard I quarter, that. then question. to think our parts question, for thanks second the Great, just in with update first

communication towards shading or the to update? investors in And or to remind to earlier you timeframe as either provide expected perhaps us quarter that closer depth learning to of just then January closer being First later the could was March? able following to the that the anticipate you what

So, when DSMC that six an the to a and drug DSMC trial difficult data. the their for benefit, there - like efficacy. quite - disclosed DSMC of to they're want no to first looking planned, to because the publicly going so you not because a survival exactly middle in be. stop was this see actually rules months and this both middle; safety shows in Also, the the meeting early quite of to to to a course well quarter survival it's have date on what it's the never but as is looking to efficiency at all us safety, of of is at I every course, if going estimate exactly are of it's can we are I trial; that keep say I specific be at it meeting. as is don't know mean, telling actually insists it's before date you all The just actually trial.

going a So come to back going thorough us everything are on what to say on got every is the to they which they we endpoint and SAEs, as safe see time, they and full the and are primary drug. which it's hopefully But including data they should data getting see they survival AEs, very which all PFS. it, overall secondary always is a course that endpoint are safety, quite is of say also, the

data a have very way pivotal they're blinded going we secondary is [indiscernible] basically actually, they're we going This is trial. trial. blinded. second What be to disclose? see a over they're going expect that to careful On data the we response a much to is And be, the end because course, at the of the the to keep which which CA-XXX, in very similar and are rate XXX they patients to see Not recruited of that patients. going data to that the time, be to on all and to with see

it's gave far, able hurt [ph] promising looked and what to very trial we data, the will trial agency. this way in to that and to say probably It's data, wants well most light early. to And nobody they have be way a very high go even green if of drug with unlikely in a that they a will is that rate the at enough any at So trial the response us therefore, point the on. because they really working stop

That's my the extremely questions. progress. helpful. Listen, congratulations all Thanks taking for on

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

the colorectal the Thank get questions Dror there answered you give design sense my when Since and an Amos. if that you all in could regarding afternoon, and study, color well, the us could is you. some at the additional interim cancer we first regarding Good look analysis? also already data potentially

So you, thank RK.

- National are cancer cancer, and done of this you the recruiting together with actually As Institute colon trial which with Cancer beyond is patient therapy. we care standards are metastatic colon know,

a chemotherapy, failed checkpoint them of failed most So already of them lot inhibitors.

usually first patients. checkpoint expect two recruiting know, before system to the them in first dose these in from just and from inhibitors open the work usually what and nivolumab a third every getting tumor VB-XXX They're will the and going don't we actually ovarian are there tumor it's to we dose we on is are In they they a be have viral that Although of both expect is but you we while that VB-XXX, in the half is early, call there. biopsy. they're immune And a first particles. and a the trial. weeks, it's six second tumor, get to colon the trial, should the bit a system It's everybody XX what second to metastatic show the of getting where will nivolumab. and the to weeks because get the to liver have in to will of on nivolumab Two their later, involved they cancer, to in cancer weeks VB-XXX then getting biopsy they to going did single-arm show combination a new a know week, indeed same through, we lesion going we basically XX this every nivolumab, no alone immune recruit that okay doing what get they're system biopsies day, that a that get we biopsy of see are the

are way, inhibitor we tumor to will system into the and the we it. then the course, priming of this hope activate So immune that checkpoint bring

the VB-XXX system half reaction The biopsy VB-XXX get see the what after to biopsy just of nivolumab. didn't dose that will before of VB-XXX, get of the immune to is combination the second second patients plus just a

tumor. to that colon the become will soon. We sometime have indeed turning going or biopsies to us look are by estimated we the first cancer second tell we at hot So actually we these quite are mid-XXXX if a in will results quarter,

the looking any will the Thank you. you tissue? you Will At biomarkers do biomarkers? doing the you biopsy, any be time to also addition at be in

a be there the are including course, tumor going Of genetic, everything. of genomic, proteomic, to thorough investigation

Perfect. And IND to next file half be needs you to second year. or then the work get on MOSPDX, in additional what before done inflammatory indications of the

a actually, to we testing. the need So IND, for toxicology complete

preliminary disclose, clinical We are for got results, And doing to trial. are right We it quite I'm now. goes everything course, a making we well. of already the which but not forward batch going the

the hopefully will of to IND the we start the sometime be towards second able we to expect the So submit study. in to half XXXX and of end year,

Perfect, thank you questions. my for you. Thank taking

Our Please next Jones question is from Soumit Roy with Trading. proceed.

is question given your the sites expansion the data being Hello, everyone, DSMB? enrolling? Thank that seeing and for If of are the patients congratulations you how will you. that's How on many can all any that you you tested first the any enrolling sites progress. to separately? be give the And Are interim are currently OVAL number very trial? promising data rate being seeing the of second collecting on enrollment us Are you in in presented from second COVID-XX? is and uptick If ongoing A on presented the of or interim? the quick the trial. and the

in and of centers Sure. have lately, question, To States, opened Japan Israel planning first and of are quite United we answer now your centers the we some them open most to soon. centers XX we Europe in in in some and them

our just not centers opening in vibes in are centers GOG the very And getting it's States in recruiting recruiting, centers. organization. we're that of but already also [ph] United actually, recruiting going not in part that from and well actually just So in also new

well see. members go from hear what that mainly Committee, very pleased GOG of are do with which doctors and we they quite things the Steering So is

information trial. we tested blinded COVID-XX. all two much three There are XXX% patients recall COVID-XX. them issues. from not not we information, or infected got right, get that some were to because if I that course, I unless only, this the too patients Of about this I'm stayed actually of for trial with And think But sure have try on

will now. analysis right only patients for infected think minimal It's a don't do very we of to that that COVID-XX. I need were different number So, patients with

you Congratulations, That's Thank much. perfect. so again.

very you much. Thank

Our next Capital Aschoff Please is question proceed. Jonathan with ROTH Partners. from

will you very further Drew, successful the bogey as with deem the guys colorectal result enough you're that trials? What's trial you for much. with to Thank nivolumab. looking proceed What [ph] for?

a you're some course, of of that everybody I in think a actually a small patients. see you giving studies So PFS say that hot into them tumor major wants educate of very I'm them cells for, and systemic and about always, won't from endpoint a is that to procedures a signal of the all cold into and a vivo a in the response number terms we tumor. resist; tumor now complicated numerous change familiar infusion But are looking put term back I simple lesion, sure of tumors. when injecting talk with IV - with done taking ex to

All with this is quite complication. of a lot of really complicated

to do I show even can to this bigger enough then a actually indication. just turn we that good do make and be colon of see a thing be on control this a some will will cancer tumor lot combination Even we that there that relatively cell a a away. to to we bringing decision immune trial small hot if maybe in randomized the more the signals, right than right and trial did think

where Okay, written this and I patients I've of How trial. down [indiscernible]? the many can't size see

at and first are The becoming all the It the get planned to after on NCI to that doesn't to patients. about is to be biopsies patients. Okay. that results way size tumor. hot about mean look tumor up they're X if XX The XX we actually a is go going going trial idea the of this XX is to the patients, to

in mid-XXXX. the are we that's expecting first that result the So

took protocol indication can it needed. And see colon increase if XX the other in also in we cancer in can If it the we GI. indeed actually, but patients, to is cold turn about extend tumor NCI now, GI. other right at the increase do we plan to actually to hot, we So it indications that

So the we to have of it's whole idea if clear study are quite because blinded. can the this cells, from teasing in inflammatory chemotherapy. what we repeating of - in it call that of at tumor But seen we're cancer are - cancer, ovarian you we see that ovarian indeed study, a look every in they're just biopsy that's including we and a where done that to from with Phase lot right, not we biopsies taking, X know patient this see coming biopsies

So cold tumors change we do, VB-XXX hot. does

you right, Thank that you had simply because response, have XX% for the of for XX? minimum to first response And XX% that. the rate a question blinded to was answered the taking you

want give me moment at rate. more XX% was had in one interim all I know clear. blinded No. make XX% relatively from XX% the to the population least that we on that chemotherapy population, I We're we talking how asked very a and can if response in VB-XXX. the At that over then that know we And saying? arm already it's total the I the know much for treatment but it over XX% XX% low about you are we total in response be and specific, rate this

treatment much arm. in we than to XX% So the expect more it be

patients XX% roughly? saying based you XXX are on That Okay. is

That's right.

much, Dror. Thank you very

you. Thank

proceed. your next live. is Jonathan, from with Our Research. Valore line Jonathan Instructions] question [Operator Please is Kreizman

Dror, Aamos, me? hear you can

of course hear we Yes, can you.

encouraging the patient beginning Okay, from on their we're to enrollment so shared outcomes OVAL positive from some women trial. who in testimonies see forums some

analysis, kind results So the for will, the required of threshold the next either process? are to stopping do to and if the and in out OS interim recommend upcoming DBMC initiate blinded to the think PFS higher evaluate trial or do what the and if sporadic outcome you to is acknowledge the OS of course company results, filing indicate testimonies, eventually I be would the PFS turn these you and these while company

you as show the something statistically unless statistical calculated at curves two be enough a X.XX%, should for that to [ph], significant and that guess DSMC. the pre-specified overall PFS like told forward X.XX% ratios hazard like they if asked the way arms. is getting so I So two for hazard Because which I not significant X.XX% survival, we'll any an the they're to indeed separated this it's see difference about it's a a we'll tell actually secondary Kaplan-Meier for a but good And so gain look that, between were is for X.XX% in curve, you to will now it's ratio. [ph]. question know

of that the this that sure drug Committee we put - So, this indication. the are never if the DSMC, special agency will if the decision exactly very is Bradley of pivotal will be in there the I'm Steering a a something they market is they you a Monk, one make on GOG it way. I a difficult assure X.XX%; have not a like trial can happen take But we know, careful a But meeting very of study on strong will usually is monitoring in and because we're decision. leaders when beside they very chaired to a by you with that alone; the which like Dr.

GOG the Committee, testimonies most a the patients, the vibes which lot reading from of to all as these the as guess, that because taking can of quite from care are it by optimistic. not do allowed they're we you we centers, company. of not as actually are get are purpose But We a Steering patients,

MOSPDX. great. question on Okay, second Then,

or is So how the whether of and what ahead budgeting maybe financing, approach phase? clinical you're XXXX? expect to planning you a initiate this or the the partnered to standalone point trials at with the on you in could trials clinical share And sponsor, some planning thoughts

has you all the the be go XA, budgeting, not know technology which from a careful to So going all novel to our that's in such the you way end expenses and dose that in of higher and one actually a very the low plan of we such and the and strong as have already a indeed if diseases because data in to and all a now we're for type therapy certain right it's work, expected the it of geared till very preclinical novel won't XA have it a indication, of develop course, to And XA the way to the Phase be at point, dose develop big we calculating is a because immuno a But results Phase assume we novel are including that inflammatory the when to be trial. will Phase study. alone. we a end

Okay, that's helpful. Thanks.

reached I the our conference end to have management to turn remarks. We of closing over question-answer-session. back would the like for

So joining this very on you thank all future. you, good in more to able hope call to all, today for the Thank much. us news and we tell be

Thank you. conference. today's This does conclude

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