Q1 2020 Earnings Call
Greetings and welcome to the VBL Therapeutics first quarter Twentytwenty earnings Conference call.
This time, all participants in listen only mode, a question and especially following the formal presentation. If anyone should require operated assistance. During the conference. Please press star zero on your telephone keypad.
As a reminder, this conference is being recorded.
I would now like to turn the conference I was a cheap.
Mr. Michael would have left side advisors. Please go ahead.
Thank you operator good morning.
Thank you all participating today's first quarter 2020 results and corporate update call VBL therapeutics, leading the call today will be professor Dror Harats C. O I was wrong the Companys CFO.
Press released to the Companys financial results became available at seven o'clock Eastern time today and can be found all the investor page of the company's website.
Before we begin I'd like to remind everyone that various remarks about future expectations plans and prospects constitute forward looking statements for the purposes. The safe Harbor provisions under the private Securities Litigation Reform Act of 1995 bps cautions that these forward looking statements other subject to risks or uncertainties that could cause actual.
<unk> results to differ materially from those indicated any forward looking statements made on todays call speak only as of the state of the cold and that's Thursday May 14, 2020 of 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, the coal is being recorded I will be available for audio rebroadcast on the company's website as the operator mentioned all participants are it'll that listen only mode there'll be a brief kinase session. Following management's prepared remarks.
So with that I'd like to try to coal over to professor.
Please go ahead.
Thank you Michael and good morning, everyone. Joining me on today's call is almost thrown our chief financial officer, well, we'll discuss the first quarter Twentytwenty financial results.
The first quarter of Twentytwenty has been very productive for VBL and we have had and number of important developments since the beginning of the year.
Most notably there was successful interim analysis in the ongoing.
Phase three study in ovarian cancer, showing at least 58% objective response rate to VB 111.
We've also made progress and announced new data in our most predictable programs.
Based on these positive developments over the last week, we successfully strengthened our balance sheet with $18.1 million in gross proceeds.
You know registered direct offering from new institutional investors and key existing shareholders.
Beginning with the overall interim analyses overall as a reminder is an international <unk> phase three randomized pivotal registration clinical trial in patients with platinum resistant ovarian cancer that these comparing combi, Nick combination or we'd be 111, Dopeless say both both.
On top of Paclitaxel standard of care.
Studies primary endpoint is overall survival and secondary endpoint includes PFS and objectives to more response, according to see a wants ptwenty five and resist responses.
This study was designed to enroll approximately 400 patients.
Hi, it's being conducted in collaboration with the GE GE Foundation.
In order to mitigate risk when we were design designing this study we included pre planned efficacy interim analyses to be performed by the independent data safety monitoring called me team the golf season, not as east west or see in an early stage.
The study if we can replicate the positive signals that we so in our phase two study our accordingly de Silva interim analyses compared this CA 125 response rate measure according to the strict juicy igene criteria enter.
Great and then I'm control.
And most of the first 60 evaluable patients.
There was a pre specified efficacy criteria on for continuing to study, which is an absolute percentage advantage for that percent or higher into say once ptwenty five response in the VB 111 Christmas.
Versus control.
Into analyses the comedy confirmed an optional percentage advantage of 10% or higher in CA 125 years phones in the VB 111 creep up Vericels control all.
The call me to also confirmed that the commodities see I want to 25 response rate of all 60 patient deemed analyses that is both a combined is 53%.
Since we also know that there is an absolute advantage of 10% or higher into VB 111.
We can make the deduction that their response in PB only 11 Christmas Tom is 58% or higher.
From this analysis, we can see that the interim see want Ptwenty five response rate for the VB 111 into all of a study is at least as good as their response rate that was seen in prior phase two study of we'd be 111 in public stock sale, that's enrolled seem a lot population of pay.
And with platinum resistant ovarian cancer. This time, the dots are coming from a randomized blinded controlled study and it's part of the phase three trials that we are running.
And not are supposed to find D is that response rate associate with fever fever inflammation is collect that this part of the trial safety data.
Our previous clinical trial, we've seen that about 40% of patients dosed with maybe 111 developed a classic and distinctive feverish phones, meaning that they developed fever within hours from dosing and the fever, usually subside by 24 hours. This is no.
It's surprising seems VB 111 is a vial based gene therapy does not show that in those patients to experience fever that are most likely our own the VB 111 treatment.
The response rate was even higher 69%.
Following these positive results also preplanned interim analyses that DSMC recommended continuation of all of 'em trial as planned and that's a worthy Scott in a capital call that we hosted on March 26 that feature our presentation by Dr. Brad.
Only monk well, you're still fresh start Guinea called you can call G.S. University of Arizona and the German also on study steering Committee. If you did not yet have chance to listen to these the replay is still on our website.
There is a second interim analyses built into the although study, which will assess overall survival is that to treatment arm for futility. These analyses will take place after 100 patient a follow up for at least three months as we already.
Successfully enrolled those 100 patients these are not as easy as expected into third quarter of these here.
There are two other trials with maybe 111 in metastatic colorectal cancer.
And in recurrent GBM in February we announced.
The launch of the phase two clinical trial of we'd be 111 in combination with Nivolumab.
And on the Btwob immune checkpoint do you need be door into treatment off metastatic colorectal cancer. This study is being sponsored by the National Cancer Institute Orencia.
Under at Krotz agreement and the eyes. The application has been approved by the FDA. The initial target enrollment is 27 patient and if we see activity in these patients.
We'll explore testing the combination in other G.I. to Mars and this is an open label trial, we expect to have first resolved I'll start recruiting seven to eight to 10 patients.
The study in recurrent GBM is an investigator led studies sponsor by Dana Farber Cancer Institute in callable right collaboration with a group of stopped their own colleges in the U.S. and no major medical centers.
It will investigate neoadjuvant in Atlanta treatment with BP 111 in recurrent GBM patients undergoing a second surgery.
And I'm the application for the study has gone into effect. We've asked the eight and if successful we hope that this study will generate resolved that can potentially be part of future filing wins or regulatory authorities.
They support by the National Cancer Institute, and the Neuro Oncologist consortium clearly shows that there continue to be a lot of interest in VB 111 enzyme called you community, we expect to stop patient recruitment as soon as Cobiz 19 situation allows.
Also regarding two VB 111, we announced in April that following the positive interim data nano carrier, which he is a Japanese licensee for that product intends to extent they ongoing phase three almost study to enroll patients in Japan they will.
You are responsible for that required operations and expenses related to the study in Japan recall that in 2017, we signed an exclusive license agreement, we snow carrier for the development commercialization.
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Suppliers, maybe want to 11 in Japan.
We're pleased with a decision to extent of out as it will open up another avenue patient recruitment and will accelerate commercialization of we'd be 111 in this important market. According to the time of our agreement we'd be out can potentially receives more than 100 million.
And I was in development and commercial milestones payment from national carrier as well as a high teens royalties on net sales if the product these approved.
Turning now to our most pivotal program earlier in May at the DDW Conference, we presented data showing the potential of our must be to anti bodies in models of Nash ankle like these we have shown that must be the two plays a role in that.
I suggest as each of these diseases and that targeting must be to using our proprietary specific monoclonal antibody VP fix a one.
Can offer a meaningful therapeutic intervention and potentially advantage and differentiating 0.4 days approaching Nash is that it's opens the possibility of for treatment of patients we've established disease.
Her has advanced stage stages of inflammation and fibrosis.
Similarly treatment with our optimal speedy to a profile proprietary antibodies was shown to reduce disease activity in an inflammatory bowel disease.
Our proprietary anti bodies can block monocytes migration and thereby affect the chronic inflammation inflammatory process Vbls innovative study was right. That's in the top 10% of all ops and was selected as a poster distinction.
We also recently published a paper or.
We also recently published peer reviewed metal scrape on the potential of targeting must be didn't do as a treatment for M.S. in the journal.
Clinical and experimentally immunology. These data showed that knock out of mostly due to gene in mice protex that the animals from developing CNS disease E, which is well established experimental model for I Miss Furthermore, VBS proprietary I think.
Most people do antibodies that's block model size migration, we're assuming already shown to reduce inflammation and tissue damage. These open up opportunities for potential treatment, all three lapsing as well as progressive forms of M.S. disease.
Our lead candidate antibody VP seeks a one which as you can see has potential for multiple chronic inflammatory diseases is advancing toward a first in man study, which is expected to begin in twentytwenty why.
We also made important progress in our cutting edge technology MOCVD tool by specific antibody program for solid tumors, we expect to present, new data, including a late breaking even poster at the upcoming HCR virtual unwell meeting in June.
For information on our bi specific antibody program will follow in the next few weeks.
I will now turn the call over to almost rone, our CFO to review the financial results for the quarter I'm most.
Thank you.
Hi, My name will the colder than most.
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Revenues for the quarter and just months.
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Research and development expense, Matt were approximately four.
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The quarter ended tomorrow.
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Financial income that one of the first quarter.
He was approximately 263000.
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For the first quarter, though.
Well the first quarter ended March.
With the review will do the math laws.
5.4 million goals.
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The $4.2 million old since.
At March 31st with other than Brent Ti VBL had cash cash equivalents short term bank deposits and was the restricted deposits.
Totaling $51.6 million and Virgin working capital of 24.6 million goes.
There were a couple of both periods events, the effective or balance sheet.
First thing they we were awarded Nondilutive ground up too little more than $3 million.
New use early shekels, sorry, oh or approximately $9 million.
By these really utilization.
And finally as Jordan mentioned on my.
Severance.
Entered into an agreement with several use institutional investors for the purchase and sale of approximately 6.35 million ordinary shares that's a price.
1.575, Belows for sure.
Registered direct offering.
Brian the markets under Investor groups.
In a concurrent private placement, we also issued to the investor interest to.
Unregistered short term warrants to purchase up to the same number of ordinary shares subsequent to this offering.
Earlier this week some four key existing shareholders invested in the second buffering under the same terms.
In vote of confidence in the company endings prevention.
The gross proceeds from these offerings.
I approximately $18.1 million before deducting the placement agents for use in the others to meet their operating expenses.
We've done certainty around the covert 19 pandemic, we believe that this fundraising was an important and necessary step to security operations and the continuation.
Right.
Under the current operation operating plan.
We expect that our cash cash equivalents and short term button.
We'll be sufficient to develop maybe 111 and other product probably dates and fund the operating expenses in the capital expenditure requirements into the third quarter 2022.
For further details so no financials. Please a true to form 6K fun. We've asked you see this morning.
We'll now open the call Wes.
Thank you, it's timing will be conducting I question answer session.
Good question. Please press star one telephone keypad.
Consummation time will indicate your line isn't the question King.
You May proceed start to see what I currently via questions on the Q.
He said he thinks they can equipment it may be necessary to pick up hence handset refocusing the case.
Your first question comes.
Comes from Jonathan actual fumble capital partners. Please go ahead.
Thank you and good morning, guys I was wondering given the recent paper and the oral presentation.
My last PD too to what extent can you describe this that's the partnership discussions and inflammatory disease.
I think a once you talked about.
[laughter] potentially.
Strategic.
Hey agreement only when they do happen and of course, there is an interesting around these very novel technology, especially when we present data.
But I prefer to actually talk about it if things will mature.
Okay, how about 'em can you say anything about initial cancer indications that my bias or you'd be stick so to toward or is that we're too early.
[noise] so it I think it to be the early but I can tell you that say when we are testing 18 a.
Hey, animal models, and they just say and want to make it clear six to one in six or tool are actually a monoclonal antibodies for inflammation six to one is our lead compound and six to do is our big component.
Takes 111, he is an hour by specific candidates. So it would be easier. When we are having gained six oh it will be for inflammation wouldn't stop me six one it would be the bi specific so the 611 is actually was tested already in vivo in the two different a cancer type we're going to elaborate more.
Hey, Seattle, but I can say now that it was in there a.
Triple negative breast.
Breast cancer and in cervical a culture, we believe it will work in many different solely to Mars and it's a bit say a early to say, which indication we're going to at this first but.
I think that we should all look forward for they a.
That data presentations that we are going to actually presented a CR I know that tomorrow morning. They are going to publish say obstruct it's going to be into public domain and they I believe that we will have a press release to follow in the beginning of next week.
Thanks for that and lastly, what is a clinically meaningful oh less difference at a three month with those hundred pension and do you have a.
The better sense of the PSS expectation then you had a when asked US back on March 26, when they enter the person from came out.
So as you all know.
It was a very unique a interim analyses that we de DNA in March because at that time, we basically planned and if he can see a.
Meaningful differentiates we have to see in CA 125 to go forward because that was basically go no go decision on how closely people what are they a chances that these would be positive trial and indeed with this very good results that we got in these interim analysis, it's quite clear that we de risk the study quite.
A significantly nevertheless, CA 125 is not the primary endpoint, it's a secondary endpoints. So a bucket was too early to look for survival. So the first time to TSMC is going to look at survival, but they are.
Hey, they only want it's going to be unblinded and they they of course going to tell US go no go and they're going to look at an overall survival for the first time, we'll do it quite early.
But the TSMC is meeting every six months and each time they are getting a very important table, where they're seeing PFS in dose group and now of course on light it and always seem to go screws and they're seeing the maybe on and they're seeing if they see statistically significant.
What I would be a just very carefully in saying that this trial is blinded and because it's blinded we cannot a give any information on a how the data is divided between the two groups because we don't know buttons and we already know.
From the C 125 that actually their response rate is going very.
Very well into right direction, which mean that say a patient on VB 111 are responding in a much better way then of course, a control arm. So if we do see high response right. It's very encouraging if we do see the PFS is much longer than was expected with chemotherapy.
According to all the air historical control studies and the same for the whole with its make all of US really encouraged another thing that we always can do and of course, we are not going to a put it in the public domain, we can look and see how the patients at the Battle Creek over which we know that they are older drugs are.
Responding in terms of PFS and always so we all have to be patient for they a mid summer.
Where we will have this entry analysis in the third quarter it would be.
And later on I believe that even the most importantly, a timing will be the next meeting of the TSMC in the beginning of this 21, because that would be already at times. It it would be really meaningful to see what we are seeing in PFS in the with no you all have to remember that this topic.
As for 100 patients. It's a big study that's already recruited more than 100 patients. So what you do see in the first onto the patient as Dr. month was saying is usually what you will see a in the following bottoms. The study because it's not looking at the small group so into summer it will be at about 100 patient.
I believe that in the beginning of 21, they're going to have that Oh.
About half the patients in the trial and that would be a really meaningful.
Thank you George you just kind of popped in one last last question not how has cobot 19, you know sort of temper the enrollment in the last couple of months for all.
Okay. So for the overall, we were a quite surprised.
Cause a wonderful day I assume that's almost no patient would be recruited in the trial at the situation like the coffee day 19, we are recruiting patients. We are randomizing patients, we are a bit slower than at the plant, but not in a major way in any way and.
We are.
Randomizing patients.
Every week.
And we are randomizing almost seem to based as we were planning to randomize patients it's happening both in Israel in United States I believe that one of the reason for that is we're talking about and deadly disease, where there is no much to offer to patient and the doctors that stop recruiting patients in their centers.
And so response rate into one to develop fever, and so the C was 25 interim analyses are really encouraged so just as an example, we offer a patient to get there and the Paclitaxel, it's a long dr. clinique, none of them too.
And they say a new approach and all of them came to the centers to get the drop so we are actually getting affected and beat but not in a significantly.
Okay. Thank you.
Thank you very much them.
Thank you Sir your next question comes from ran ramp a cool I would hate C. Wainwright. Please.
Please go ahead.
Thank you thank your <unk>.
Sure I hope you're doing.
Okay, all right and staying healthy a couple of quick questions I know I'm sure I'm sort of a lot of questions I bet.
They had [noise].
For the Oh, Oh, I'm just want to make sure did you say the second interim analysis of the sometime in the so it's something that third quarter or did you said today talking about.
What kind of no no theres both.
The interim analyses that is 100 entities. The next interim analyses she's going to be into third quarter Twentytwenty.
And this interim analysis is what I was saying that for the first time. They are looking at overall survival and that's when we have 100 patients.
Followed for at least three months.
That's going to be in the third quarter of Twentytwenty I was asking.
From then on every six months the DSMC he's going to look at all of course safety, but all the primary and secondary endpoint and of course. The reason is that the study primary endpoint is overall survival.
All the drugs on the market in.
A platinum resistant ovarian cancer, none of them has improved.
If approved on overall survival and if a drug is actually prolonging life want us to be very careful if you are allowed to people, giving placebo now.
Okay.
For the study itself I know aren't you kind of give some qualitative.
Information regarding how it's getting involved so is it possible for you to tell us Oh Oh.
Oh, no patients are being handled at this point.
Well before them decision, but do you mean.
Yeah, we always very carefully and they're talking about and number of patients because you know it can vary from one month to the other as you know we were mentioning that we've recruited 100 patient and that was actually at the end of.
March were going into right pace that we were planning.
I believe there would be a bit delay in opening gay Europe. He told because of the company had 19, but now that we have Japan to join US. We all believes as we will make a timeline that we were saying for the VB 111 noble trial.
Talking about Japan.
It's it's good that Manorcare decided to you know extend.
Get involved in the old trial so.
Well this datamyx.
Next up is that and then trying to give you.
I'm trying to get some patients onto the trial.
Or is there is there something else.
Needs to be done in Japan before they can get on the job censorship, some paperwork and stuff, but it's to be get done.
And how quickly can though.
Yeah. The plan as first no carriers stoking to be M.D.A.A. quite a significant time and they were getting all the guy that's and everything and right now they and they're going to you is a all the vendors that we are using into Trialing swamping trial, we are controlling the tried but they're just a taking care of apart enjoy.
So it's got to be a rated one trial, they're going to have a local see a road that they are a recruiting right now and the plan is that.
Everything will go well.
Now when we have they called it 19, everybody should be very careful in a talking about future, but the idea is that already in twentytwenty, most probably in the fourth quarter, we will start recruiting patients in Japan I want to emphasize on why Japan is so important.
First they're going to take part also burden off these trial actually all fair off their shoulders ofi be out because they are going to fund older patients it down in Japan and of course, we are going to end 400 patient total regardless of where they are where they are recorded second thing is that they will.
Expedites the time that we will get a to the last patient gain of course into stride, but it also will expedite the time that they wouldn't be able to register the drug in Japan, and the NAV southeast Attia, if and as we hope that drive we'd be positive because as you all know that.
You need to have patient from Japan, or South East Ashley and a sick patients to actually air registered drug Hey, both in and Japan, and China. So for US it's a very big advantage that they are joining the trial.
Thank you to a one last question for me on the Oscar.
On trends.
Outside of the C. I want to defer those funds data is that any are these anything additional that we could see in in the presentation.
[noise] Unfortunately, no and I was saying, okay in a very careful way, although we look at a blended lined the doctor and we're really encouraged.
It's blinded data and we're not going to.
Say any numbers or anything that we do see following the trial you said the SMC one common say something.
Going forward of course will say, but that won't be in these ASCO meeting.
We should be patient about.
[laughter]. Thank you very much a drawer and good luck with everything on purpose.
Thank you.
Thank you Sir your next question comes from plant and Plecki mid last got less capital. Please go ahead.
Hey, good morning, everyone. Thanks for the questions I'm just have Warner real quick just regarding the fever biomarker that would be great you get your take on potential for this to be used in the future I'd say cognos or prognostic marker and then based on the data you've seen throughout studies will be 111 today, yes are there any clearer differences or you've seen.
That baseline between those should do and don't get a fever I know that some of the data is blinded, though thanks.
So that's an excellent question because we always ask yourself Sam if the fever is just a signal of patients are doing better. So actually there is no different things kind of stay between the treatment and the untreated group. So one cannot say that because they're independent well being that doing it and we don't see about Kindle ski when we.
Compare the Wanda developed fever, or don't develop fever, and actually previously we already published that there is.
A very unique a cytokine.
Elevation worry and map cytokines that increase with its fever and by the wage north denials seeks out six and Christmas Peter but that's not a biomarker we're talking about so looking at all the data from a the many different tries the only ran with VB 111, it looks like that the fever is really.
Bio a marker here in the trial that actually at first it say signaled that Watson specialty is on the drug but second to want to develop fever. I'll go there are knocking the better karnofsky scan or anything like that they are usually have a high.
Prior response I'm not sure about say almost trial because as we mentioned 69% of station. Please fever had to respond and there at the VB 111 total group it has to be more than 58 to actually if you calculate he tried to even more than 60. So it's very close to each other so it's all done.
Pens and that some say 125 of course, one it's meant to be seen what does affect it will have on PFS and always but as we were saying before there is a very good correlation.
On patients treated with VB 111 between the San Juan 25 response.
Just to be scones, PFS analysts and we sell baked into phase two and when we had a chance because in the first interim analyses, we got more information than usual, we could see that that's exactly.
And what's happening in this a group of patients. So we keep on seeing that's the one that has seen 125 a response.
They have a better PFS. They haven't that are all last and as you all know with chemotherapy. That's not the case because this chemotherapy they couldn't find any correlation between a C 125, and a PFS and also asked and I believe that's a reason is at least chemotherapy. Even when you have a response, it's a very short response.
We see I will say maybe 111 their responses that we are seeing are very long responses.
Great appreciate that thanks.
Okay.
Thank you very mechanic question.
Thank you. Your next question, it's from Jonathan crisis that low rates that please go ahead.
Hi, good afternoon. So again most of the questions have been answered.
Maybe one on the.
On the Japanese studies, so we know there I ethnic and genetic differences between the populations as well that's in terms of club graco per census patients.
So are there any additional clinical sectors, you need to town or versus your original study with the Japanese patients eventually placing the European patients.
So I think that's one of the reason Jonathan that they'll sort is in Japan and in China wants to add.
Add these patients we know that ethnic a group behave it'd be differently in by the way they looked at behavior beat differently in terms, you'll see 125 years African Americans they have less they want ptwenty five as a biomarker in they ovarian cancer, but that's not the case in the Japanese patients actually there.
Behaving very similar way to go Kashi and so we didn't need to change anything in the trial.
Okay, and then maybe you could provide more color on when you expect that you'd be m. study to kick in so you mentioned that you're waiting for the cobot situation to to improve Nevertheless, GBM is obviously dudley or as deadly has varied and maybe even more severe so.
Maybe if you could provide more color on when realistically you expect to start to kick in.
So I must say that even during the copied 19, a pandemic they a. I, albeit to Dana forever basically approved the trial.
It was conditionally approved they needed to get some answers, but basically was approved even during this pandemic, but I'm a little bit reluctant to opened centers in the middle of the pandemic. So we're waiting a little bit now we're looking to see where the centers are that we're planning to actually go some of them are in California, it's not an issue.
One of them is in.
A new York I wouldn't opened the center right now so when we will as a more clear picture, we won't come back to the market than say something right now we prefer to be silent on that until we know that we are really opening centers and when the centers will be open then of course, it's not yet.
We are most medical centers are little bit reluctant to open centers right now if they are openport drives and of course, they are trying to recruit different recruited already patient they're trying to keep on the patient, but a to open new studies in places like in New York, It's very difficult income.
For now I believe it won't be it difficult anymore, and we will try to work on it.
Okay, great. Thanks for the details.
Thank you ladies and gentlemen, we have reached the end of the question and answer session I would now like to end the call back to management to closing remark.
So thank you everybody for joining the call have a wonderful day and keep safe.
Thank you Brian.
Thank you that does conclude todays conference you may disconnect. Your lines at this time. Thank you for your participation.
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