Q4 2019 Earnings Call

[music].

Greetings and welcome to the VBL Therapeutics fourth quarter and full year 2019 earnings call.

This time, all participants are they listen only mode. A brief question and answer session will follow the oral presentation. If anyone should require operator systems. During the conference. Please press star zero on your telephone Keypad. As reminder, this conference is being recorded it is now my pleasure to introduce your host Mr., Michael what with like side buys or thank you you may begin.

Oh. Thank you operator good morning. Thank you all for participating in todays yearend 2019 results in corporate update call for VBL Therapeutics.

During the cold. This morning, we'll be professor Dror Harats CEO, the company and I must run the companies see Oh.

A press release and actual results became available at seven o'clock Eastern time today. It can be found on the batteries page of the company's website before they get I like to remind everyone that various remarks about future expectations plans prospects constitute forward looking statements stuff purposes, or the safe Harbor provisions.

Private Securities Litigation Reform Act of 1995.

Ill cautions that these forward looking statements or the subject of risks and uncertainties that could cause actual results to differ materially from those indicated any forward looking statements made on todays call. This whole speak as only up today's date birthday March 19th.

2020, the company does not intend to update any of these forward looking statements to reflect events or circumstances that occur after today's date.

As a reminder to call it being recorded it will be available for audio we broke cost on the company's website.

Operator mentioned all participants are initially analysts the only need mode and there will be up with Q nice session. Following the company's prepared remarks, so we thought I'd like to try to call over <unk>.

C O Professor Dror Harats. Please go ahead.

Thank you Mike Good morning, everyone today.

Our operating highlights.

Our blacks Fork Twentytwenty.

Joining me on today's call.

Also on our Chief Financial Officer, Oh, Gosh, our year.

And 19 financially John.

Maybe I made significant progress Wow.

I'll have to 19, and we hope on National Man.

In the year ahead.

Here, we will have.

Any kind of crime <unk> comedy day to day me 111, and we expect generate.

And your Doctor Oh no.

And our must be didn't know programs, which are advancing well.

So we don't count Twentytwenty potential.

Hi, Rob here, how long the company.

Let me begin with an update on our phase three Oh hot attention registration study.

Castigating Hate me 111 in recurrent platinum resistant ovarian cancer.

We announced in December the completion of patients enrolled Matt how are the first entry my knowledge. These current and their readout for some knowledge base is expected be holder and all the first quarter.

It's not easy one focused on C. I want Ptwenty, five response rate, which will be finalized according to GCG strict criteria in 60 evaluable patients.

Uh huh.

I don't know where there are all have deep outcome seen with maybe 111 into phase. Two study you know bar in concert is being replicate and in all while we choose a tax rate docket blind randomized control trial.

Hi reminder, we sell 58% right.

[laughter] response rate and see a 125 in phase two that these walk we are looking to replicate here, we look forward to providing an update very soon.

[laughter] the SMB hasn't resolved all stay analyses.

In February 2020, when announced the launch.

Let's talk any kind of trial, maybe 111 in combination with no renal mop and anti PD, one immune checkpoint do you need be door increased myself my stopping.

<unk> cancer.

He is being sponsored by the U.S. National Cancer Institute on there that cooperative research and development agreement on CRADA.

I am the application has been approved by the FDIC study, which is an open label study will be investigate priming, which mainly 111 can drive email shelf until that tomorrow, and Toronto colorectal tumors from being a more normal logically called.

[noise] inhibition safety and Tolerability de stocking wins will evaluate efficacy endpoints, including best overall response as well as even when the logical and you just a logical readout from tumor biopsies we.

We expect to have preliminary thoughts by the end of Twentytwenty all the beginning of 2021.

Second no stopping landfall VB 111 in Twentytwenty, an investigator sponsored study Oh, maybe 111 in recurrent GBM patients.

This randomized control study you spot short to bite Dana Farber Cancer Institute in cooperation with a group of talk neuro oncology U.S. Medical Center, including Massachusetts General Hospital, you see Alain you'll see a SAP University of Utah memo.

First on catering and University of Texas.

Sadly went investigate neoadjuvant large amount of treatment, we see me 111 in recurrent GBM patients undergoing second surgery.

Thanks Todd.

On top did porno inc. and Youre analyses the to work on that in 2010, 19, which I'm trying to do 10 that contradictory outcomes between the phase two and takes me trials in GBM delay VB 111, monotherapy priming and had lapsed.

Yes.

And I am the application for the study has gone into effect that we they asked Yang and we expect that these studies will launch in the second Walter off Twentytwenty.

Details on these studies.

We're unveiled at the society for neuro oncology and while meeting in November by Dr., Timo think lousy direct or and professor and so you'll see a leg neuro oncology program. If successful we all that these studies, we generate 20 soc that can potentially be possible five.

I mean, when they're going up already authorities.

[laughter] data from the phase two and phase three studies.

The 111 were probably ended December 2019 issue off the parents view Jonas.

Oh no role in Karachi, I would encourage you to meet these amount of scraped which are a radical online you may also be interested in an article published earlier this month in times oncology like doctors win and cloudy discussing the lessons learned from these trials and the.

Last fall, where it may be 111 in recurrent GBM is available online as well.

Turning now to our most pediatricians programs, we have two separate program.

Investigating bypass you think monoclonal antibodies pop culture, and the second developing classical antibody for him you own inflammatory indications.

I think I've people these.

Our being designed to kill tumor cells national must be too and the dog. It was expression isn't just specific company in multiple Omar we.

We previously presented preclinical proof of concept called approach using and bite antibody and are currently advancing our lead by specific time due date to work and I do fine.

New data from the program, where I expect a more accepted for the procedures.

And late breaking news session at the Twentytwenty American Association of constant research or a CR I know a meeting which was originally scheduled for April this year, but due to the coffee 19 situation, we probably take place on me later this year.

[noise] anti inflammatory program, we continue to advance that developmental power lead mostly due to antibody for him you only inflammatory indications with potential for M.S., Our AG and Nash, we have signed [laughter] agreement, which terrible Fisher scientific why often leads.

Pandora in down people DCM pro production off our lead candidate VB six one on right for toxicology and clinical development.

Hi, Andy submission or maybe six one Andre is expected in the second Altera Twentytwenty.

[noise], we were accepted to presented new data on must be too.

[laughter] talking for Nash and Crohns disease.

At the European Association for study also leave her or he asked Sam I know on international lever, Congrats as well as at that digestive disease week or DDW conference actually our I've stopped fall at DDW was right. That's in the top 10.

Percent off all studies in this category and was selected as opposed to distinction.

We look forward to presenting our data when this content says well take place later on this year.

In summary.

We are proud also progress being made across our company called <unk> and R&D pipeline as we continue to execute on all our programs.

We expect to have meaningful capitalist throw out twentytwenty, beginning with interim Riyadh wait out you know foreign concert in the next couple of weeks announcement of our must be two programs in inflammation and oncology.

Well one of finance went approximating $37 million into back into year end, which will take us into the third Walter off 2021.

I want to say equate corridor about coffee 19 relative to our business.

At home today, our operation I have not been affected by the outbreaks and our ongoing all have tried.

Tenure to enroll late stage of our cancer patient in good pace, obviously with the necessary.

Cautions required in this situation since we have our own it in house GMP manufacturing facility, how he'd be 111. We began has the ability to continue into production I'll say strat was relatively small effect by that called me 19 situation I.

Well now turn the call offer it to almost rone, our CFO to review the financial resolved hold to quote or.

Thank you.

We're booking revenues for the year ended December 31st 2019 relate it could be as corporation.

For opening 6 million books.

Research and development expenses net of government grants. So you ended December 31st good though than a name thing were approximately $15.5 million compared to approximately 15.9 million doors in the same period, the nice thing in twinkie.

Okay.

During the study that marketing expenses for the year ended December 31st, though they didn't like being were $4.9 million.

To $5.6 million for the same period.

2018.

We reported net loss for the year ended December 31st to go the isn't 19 [noise].

Oh for your goals or 54 cents for sure.

Birds to a net loss.

$20.4 million or 62 cents per share.

The year ended December 31st to build and then B piece.

At December 31st that doesn't mean being.

<unk> cash cash equivalents.

But because it's interesting.

Deposits.

So $37 million and we expect that were cash cash equivalents and shorten bucks deposits will be sufficient could be bill.

And our other product candidates.

Operating expenses and capital expenditure requirements into the third quarter two builder Brandywine.

For further details on old friend and so these are true to form 20-F, five we've actually seen this morning.

We'll now open the call for questions.

Thank you will now be conducting a question and answer session.

He would like to ask the question. Please press star one on your telephone keypad.

Confirmation told what indicate your lines in the question Q. You May proceed start to if you'd like you move your question from the Q.

I just didn't do you think speaker equipment, maybe necessary to pick up your hands that before passing the Sarkies. One moment. Please we pull for your question.

Our first question comes from the line, that's Kevin Degeeter with Oppenheimer. Please proceed with your question.

Hey, Thanks for taking my questions first after with regard to the ovarian cancer interim analysis can you remind us is there an option to evaluate potential recycling of that study as part of the assessment.

Yes. Thank you Caroline I don't think that there will be every sizing golf and try and due to that interim analyses because you can try my lousy she's looking at their response rate to see a wants 95 and as you all remember the primary endpoint is over.

<unk> five <unk> and we're not looking at overall survival at this point I can tell you that he wants we hope and expect to see is that we are repeating day very high response rate that we so in the case too and we know that this response rate was correlate wins.

Some five no later on in other interim analyses no question might become.

On a much more rain importantly, and each might be that there will be a change later on but not at this point.

And with regard to potential timeline for completion of enrollment for the ovarian cancer study against the kind of current trends of enrollment and you know cobot 19 is definitely in the background of this question. How do you think about providing guidance for timeline for completion of enrollment.

Do you think out your prior guidance still appropriate in light of the number of unknowns that are currently in the market.

So we hope that's what happened there in the last thing a couple of weeks or even the last three weeks and surprisingly enough and maybe that because there is not much choice for these same and late stage patients.

Recruitment trade is that going in a very good pace right now we are and in line or even a bit ahead of line of what we want it of course, nobody now and we should be on very careful way. That's called me 19, right now bought and.

In the United States and there isn't as the recruitment is going very well.

In anyway, we are not all pen yet in Europe. So we don't have a major effect on the recruitment there right now and as I was saying, we see the opposition, but I don't want to say anything because we don't know what will happen in the next couple of weeks, but right now looks that patient are getting to therapy getaway.

<unk> recruited and even today, we had another aarons conversation so I believe that.

And as you all know I haven't.

I'm also heading and these are b.

A committee here in Israel, and we look at different price.

I believe that that effect will be on every trial somewhat but much lasting oncology trials, where you need to create the patients.

That's terrific one more for me, maybe then I'll get back into queue with regard to acceptance of the late breaking abstract phrase see our first congratulations for that niche terrific see validation of the science.

Do you see our at least in the context of.

Clinical data has suggested to sponsors that they may not you know penalize for future presentation at their conference. If the sponsor moves ahead with publishing the data you know prior to yeah. The rescheduled date, you know any thoughts as to whether for yard.

Data there may be options to communicate.

Some of the findings your prior to whenever that meeting ends up being rescheduled to.

We definitely considering it and when it comes back and told them all category that I don't think that we would like to delay. This very important information that we are holding and you can guess at the if we were accepted to the late breaking news. It is important information, but we will have to.

Well these are right timing for that.

Thank you for taking my questions.

Thank you. Thank you.

Thank you. Our next question comes from the line, especially a sand lutzke with like my capital. Please proceed with your question.

Hey, Thanks for the questions are going.

Just real quick could you remind us of the contribution from a financial standpoint to anti and investigator sponsored GBM studies as far as than anticipated size of each thanks.

[noise], Okay, so definitely to major and contribution because poor. They NC I study, we are paying a very small amounts of money for administrative and the only thing that we do is we support them when they and with our drop and Oh.

All the rest is actually taking care by that.

A U.S. government and Nancy <unk> and that we that hey investigator sponsored trial in GBM, we're giving them and an education grant that is to support mainly the monitoring also tried so that the doctor will be in line offering that does that you can actually something.

Me too the agency and anti agreement that we haven't today centers is that's a dot top belong to if he'd be out and that we will be allowed and actually doing it together with them submitted to the agency, there's such a major need in recurrent GBM and you can did we get a positive results in these front.

I am I try not to be a very important issue for the patients.

Got it and then in terms of enrollment size. It each are you thinking about that.

The enrollment say hey for they aim.

And see I thought he is actually planned to be and all pen.

Single arm trial, just to see if indeed in their colon cancer, we are making that tomorrow hot and of course snack would be the case then the idea is to extend it to other indications in and G.I. oncology and asked so that's and the plan and we are planning to actually.

He and the.

Recruit about a 27 230 patient save for colon cancer, but there is I was saying we will be flexible here because it's might be that's very early we will see that's a combination A.A., it's actually working and that's why we're saying that we're going to see.

Hey, dotcom or ready to wear to endorse this year, we're doing biopsies on all the patient and very soon we will know after seven right patient if indeed, well, making these two more hawk and if we do so then of course, we want to extended in time, I'll say, a GBM trial, it's actually.

Plan does a blinded randomized controlled trial, so I believe that to Taco, we calming twentytwenty one maybe the second half of Twentytwenty, one when that and full stop be easily actually already recruiting.

I can tell me, what I'd say, a doctors will see them arises because from the operation on.

It's not a blinded to try because we have one group, we choose getting game and standard of care and the other two arms getting VB 111, any say, we'll see and meaningful things and they will come back to US we will know about it but the plan is that we will have the results financial crime.

Okay. Thank you.

Thank you. Thank you. Our next question comes from the line I ran slaying bakula with H.C. Wainwright. Please proceed with your question.

Thank you and good afternoon drawer and they lost a couple of quick questions.

First one on the interim analysis expected.

You know before the end of this Florida, so outside of the see a bunch, let me try data that you know LIBOR big.

Expect to see what other data were Oh wouldn't be present that you know from the 60 patients.

So that they get a better appeals for what the code for in India in no. The total trial data.

Okay, So and thank you our K for the question.

In the interim analyses, we will be able to disclose they data on the blended populations of response rates as we do see Louise.

You want Ptwenty five on the tone total population maybe talk about what percentage of response, we do see into one to develop fever, which we know that they are basically on VB 111, that's the most important thing is that a.

And train was designed in a way, but it will be enable us to tells a market. If we are at least as good as and what we've seen in the face too. So the go no go. He snarky, we are not where sorry. If we are the same as chemotherapy you see if we are much better than that.

Chemotherapy and that's how it's all designed we won't be able to.

Disclose exec number in each grew up this is a blinded trial until the smelter primary endpoint I can tell you what I can dance, Hey, and entry and they did somebody is going to have more information about.

He was this response, but we're not going to disclose this but actually I was mentioned before this whole go together in a very aligned way the patients that have a response to see want ptwenty five usually ever response to.

Hey by resist.

And vice versa and at least in our phase two we saw was very good correlation between responds to seeing want Ptwenty five in survival later on.

In the next interim analysis, which is taking place when we ever hundred patient day recruited.

You are randomized to the trial and follow up for at least 100 days, we're already gone to locate PFS and that survival Nationals plan today. According to assumptions of number all thing.

And mortalities between expected to be spawned.

Well. Thank you. Thank you very much for those detail.

Regarding the is the study.

In GB.

He said that could be use as a.

Good good part of FDF filing. So can you elaborate on that you know do still or should we still like they do you have to take that data.

And the globe to the FDA or is that is that something else. In addition to these studies that you will need to do before do you.

Take today did put then show approval.

So of course, all depends on the resolve itself. This trial, which is a randomized control trials that have man standards of care on them and then Neoadjuvant an advance harmful VB 111.

Indeed, we do repeat what we've seen in our phase to when we primed with VB 111, and that's exactly what you're doing here.

Then of course that would be and major thing in recurrent GBM when there weren't.

So far and randomized controlled trial that came in positive. So together with the data that we have into phase two and where everybody understand that what happened in the Gulf trial was actually and the results all thinking avastin added to the drive where I'm asking is actually blocking the expression of PD 111 and.

Taking out the target told to drop so I believe that together with all these data we wouldn't be able to highlight to the agency but of course, it's all depends on their goals. If you've tried off lease neutrons. If we are running.

Thank you one last question on on MOSFET into intense so.

I know you may not be able to talk too much about the preclinical data that you're excited.

You know, it's set up a accepted they see our but based on the data that you have so far I'm you know could you share with us a little bit on day.

Plans for the clinical development program and provide us some color I'm, such as like what kind of indications could be be thinking about.

But then show timelines you know Portland started at the clinical program.

So I'm thinking because I'm trying to think what I want to say what I can say so a I can tell you that we basically already selected they lead compound.

Based on the adopt sounds that we have and so far and there are two very good candidates that we can go forward the Queen and of course, we are testing it now into friend indication Preclinically and it's working in a more than one indication then we will have to choose.

Switching to occasion, we want to go a whole weren't there resolves all quite pay a compelling and the bottom of course, we want to have to go and day and producing unit GMP and do toxicology and everything gain needed we are having game and plan where.

We basically do right now some of this looking at and safety you will see St compound the result ways.

Initially is by specific antibody when you use a city three as one of the arms to eat cause systemic gain a side effects, we didn't see any of that so far but we are testing mahmud much more deeply to be sure that every snow there we are.

Also considering game and doing some maureen and specious, there, but I will definitely elaborate to provide much more information.

Later on this year hopefully very soon.

[laughter].

Thank you very much at your and good luck and doctors.

Thank you.

Thank you. Our next question comes from the line I assume it Roy Jones trading. Please proceed with your question.

Hello, everyone. Thank you for taking the question.

I hope you all that takes a or.

Just a could you give us a little from ballpark Gulf wind up.

Oh for for this interim data coming up this month wins that data cut them. She is a click or do you March or more in February.

And could you remind us.

When you think the enrollment completion will be for the overall it's Pete.

And I have one question one more question.

[laughter], Okay. So I asked thank you so maybe it for the interim analyses.

If youre familiar always that GCA GE criteria. Once you have to do is actually a although the patient and see if there is at least 50% reduction in CA won 25 to quality time response, and then you have to have a confirmation which has to be at least 28.

Days.

Okay from each he.

And testing we were trying to have.

Most of the 60% a person and patients that we have for the interim analyses in a way that we will have a definite resolve to either they are responders on non responders. So we finished recruiting game and they're all cohort in a personal second week.

Coffee in January I believe and kind of course, we had to keep on some a photo op. So they.

Cutting get paid for the information is actually just from sometime in the last week and that's why.

And you can imagine there are only not that many days to where they handle say water, but we will hasn't D.C. diff and be meeting and we will have the information will be able to come with this information before the end of lease months.

[noise] regarding their resolves all the pool resolved Oh. He's tried we believe that we're going to and has a full recruitment by a or towards the end of Twentytwenty. One and then of course it all depends on that he yeah.

Mortalities, we wouldn't see into trial here it will be according to our calculations. It can be about 12 months from the last patient Dean bought it all depends and we have a maximum of 18 months from the last patient Dean even if we don't get to the full number off.

A events.

Got it. Thank you that's really helpful.

And.

Well, the CRC trial or.

Oh I notice you have any inclusion criteria of from Liberum, but it's at a very common copper and sent.

Is that where do you see the crop is almost cubic trimble and you expect we'd be 111.

More than just keep it give us any color on that.

[noise] definitely and you know that's most patient we call them cancer has a lever.

And Matt that's basically the usual seeing and usually they have quite a big live or mats and that's one of the big problems. If it's too big you cannot do what we called the Swiss cheese surgery that you take off the same at this topic lesions and when we're talking about patient into stage. It there are no say responses to chemotherapy anymore.

Almost all of them if not all of them, we'll have to lever metastasis and the reason to go for liver metastasis first it's much more or it's much easier to do the biopsies, so and we depends on a biopsy here because every patient will have a biopsy.

All the way so that we will prove that diseases and any immune quotes tomorrow and then each patient will have another biopsy. After VB 111, priming and then after.

The combination with moving them up so they colon cancer and liver metastasis.

It's very important.

There is also a benefit here because I didn't know virus actually and go to the lever about 90% of what we are injecting get systemically went down to Delever and then and then liver metastasis are having a lot of neovascular churn. So it's a very good target for us and indeed if.

We do see positive results, we are making it talks in the same way that we did for inventory and then at one of the next syndication might be and went to send remark carcinoma.

Right. Thank you so much and congratulations on all the brokers.

Thank you very much.

Thank you. Our next question comes from the line a Jonathan I met with Rural Research. Please proceed with your question.

Hi, I'm. So we're beginning to see some of the Corona by borrowers dynamics impacting the CRL landscape and potentially slowing down recruitment and maybe even pushing often initiation of certain trial. So how much of these dynamics.

Are you seeing or expect to see a as the situation evolves and coming weeks are coming months for but you'd be M. study and then what are the factors you expect could impact in the initiation of the trial going forward.

[noise]. So thank you Jonathan I was separated into the different trials in a GP and try and day and maybe in the private pay assets and see I.

Might have some of things because as you were saying some tries Arnold and people are more reluctant to stop the study unless there is a major need any GBM. There is a major need so as far as of today. There is no effect on the company.

And with leasing coffee.

He 19 story and that's surprising already in terms of so far in trial, we do see recruitment as planned.

Hey, so far and even if one I haven't needle delay you all know that disease. Unfortunately, the concert is keep on and I believe that we will be able to catch up very quickly later on but thing we on in that somewhat an unknown area I can tell you.

I know for sure from and after we got from the agency and say Hey letter that every company every sponsor God and I can tell you with the same thing we got from the Ministry of House here in Israel actually there are much more and flexible right now we've not.

I'll sit rules that they have in out to run to try and so if there is a delay in monitoring its okay. You say there is a delay in imaging. It's okay. The major thing is to try and get that patient to get to drive and look for safety and you can do and monitoring and.

A veer too I'm already tore I guess, we called it or distant monitoring. So I believe that everybody is working to make sure that the studies are going on and I'm in touch with.

In the big pharma a.

I won't mention names my time in touch with them all so when we all working together on how you can keep on running to try saw the benefit to patients. We don't want to patients to die from their primary disease, just because we have restriction on becomes Wilson virus.

Okay I have another follow up I'm. So we've seen two compared to two trials failed during this quarter and ovarian cancer I want this thing a PARP combination on do you ever will the PD one agent. So at least studies Burger accumulate so what are your thoughts in terms of the possible combination study will be out.

Won them one in a barrier in either one of these.

And.

What is the medical community learning on the benefit other potential combination therapy.

The realized our data is progressing since being introduced a lot of jazz the first line therapy.

[noise]. So I think it's all depends on that and biology off a tumor and the mechanism of action Austin drugs that you're testing.

Unfortunately, PD one inhibitors don't work.

In coal tomorrow, because they don't has done a sounds to work on and a enough aren't concerned there. He is repeated taylor using a checkpoint inhibitors anything away a little bit on P.T. that you a coupon or the time people keep on doing these trials and actually.

And.

Using patient time, and patient safety and doctors time to repeat again and again and these type of trying to having thing that's because we are bringing the immune cells into the tomorrow. So combining our drive with checkpoint inhibitor might be a very good. They do you have actually.

Hi believes that one of the reasons why some patients after a long period of time to down responding to our Dr., Mike actually and stop responding gets because you have the immune cells. There, but now they are shocked to find it tomorrow and then of course, adding checkpoint inhibitors will be a major thing we're going to learn much more about.

In the trial that we are running in the colon cancer, because that's exactly what we're going to do there and from at least anymore models. We know that this combination work very well in turns off and combining it with drugs like Poppy Navy doors I believe so thats, a a makes sense but.

I will say, even more that combining VB 111, because it was to make any single function and because it's working completely different ways from others might be a good idea and different kind of regimen. We will have to think very carefully when the positive results in our all her trial what should be the next step should we added two popping up.

He door.

At the time to to patient is basically in remission I'm not sure at all because we need some two more to work on or should we added right. When you have said first sign that tumor is recurring or maybe even at that first line, but all this is a.

They all this will be consider in done later on we only have to remember that the into overdrive muscles of patients coming to this trial already fake.

Lasting and already found pop you need be tours and nevertheless, if we remain calm in the next couple of weeks and say that we are repeating the phase two where we have.

And where we basically in the case to go up almost 60% response rate. So if we are beating need even in patients that already fans papini be tours and fan avastin that will be a major de risking for these trends.

And this program.

Okay, Great. That's very helpful. Thanks, and good luck.

Thank you very much.

Thank you there no further questions at this time I'd like to turn the call back over to management for any closing remarks.

So thank you all for joining us on this call and stay safe.

Thank you very much have a good day.

Thank you. This concludes today's teleconference. You may disconnect. Your lines. The time. Thank you for your participation have a wonderful day.

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