Q2 2020 Vascular Biogenics Ltd Earnings Call
Greetings and welcome to the VBL Therapeutics second quarter 2020, <unk> earnings Conference call.
At this time, all participants are in listen only mode.
He brings question answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
As a reminder, this conference is being recorded.
It is now my pleasure to introduce your host Michael would like say advisors. Please go ahead Sir.
Thank you operator, good morning, and thank you all for participating in today's second quarter 2020 results.
Corporate update call for VBL therapeutics.
Leading the call today will be professor Dror Harats C O the company and I must run the Companys CFO.
Press release with financial results became available at seven am eastern time today.
Can be found to all the investors page of the company's website.
Our next dot com.
Well, 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 Nice 95, Phebe all cautions that these forward looking statements that are subject to risks.
Certainties that could cause actual results to differ materially from those indicated any forward looking statements made on todays conference call speak only as of today's date. That's Thursday August 13th 2020 on a company does not intend to update any of these forward looking statements to reflect events or circumstances that occur. After today's date as their mind at a conference calls before.
<unk> and it will be available for audio rebroadcast on the company's web webcast.
As the operator mentioned all participants are currently in listen only mode and there will be a brief kinase session. Following the company's prepared remarks, so with that I'd like to turn the call over to professor up Professor Harats C. O VBL Dror. Please go ahead.
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Good morning, everyone. Joining me on today's call is almost thrown our chief financial Officer, who will discuss the second quarter Twentytwenty financial results.
We are no just passed the midpoint for the year and we're very happy with the progress a company made so far and the milestones we have achieved.
Our clinical programs evaluating VB 111 continued to move forward and well work was mostly due to monoclonal antibodies.
Is advancing to where the first I'd filing.
We also strengthened our balance sheet during defaulter winter successful completion of total equity financing.
Let me begin with an update on our phase three all the study which is investigating VB 111 in platinum resistant ovarian cancer.
Well, if I heard a cancer is a silent kildair, we that high mortality.
According to the NIH official dot dot.
27 team there were over 217000 women living with a bar in cancer in the United States.
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Well, if our cancer is frequently detected in advanced stages as a patients are I seem to my peak in their early stage.
<unk> met advanced disease, usually failed surgery and platinum based chemotherapy. Unfortunately, most of the patient to achieve remission with first line chemotherapy will ultimately develop recurrent disease and each subsequent line of therapy is characterized by.
Short term disease free interval.
The worst outcome I reported for patients with platinum resistant disease.
In spite of investment of substantial resources current therapies are insufficient and are not translated into survival benefit in the vast majority of patients.
There is a huge unmet need for therapies that can extend patient survival with good quality of life, particularly those with advanced disease.
This is exactly the golf our overall study.
These controlled double blind phase three potential registration study in recurrent platinum resistant ovarian cancer has been designed to show overall survival benefit as its primary endpoint over <unk> is being conducted in collaboration with the Geo GE Foundation.
Earlier in March the independent data safety monitoring committee or DSMC also open to study conducted and if he can see interim analysis and the outcome of this was featured in a presentation at the ASCO conference in June.
The goal these analyses wants to see in an early stage of the study you said positive signal that was seen in our phase two study univar in cancer could be replicated in a double blind randomized placebo controlled trial.
They're not as this was successful.
Demonstrated that their response rate in the VB 111 treatment arm was 58% or higher with an absolute percentage advantage of 10% or higher although the controller.
The patient with most waste Posttreatment fever, which is frequently observed after VB 111 treatment. The response rates was even higher 69%, which is very encouraging.
This week.
The independent DSMC overseeing this trial completed and pre planned second interim review.
The analysis was initially projected to occur in the fourth quarter of Twentytwenty and we are pleased that eight took place at ahead of time.
[noise] that analyses slow.
And then I'm blinded data from the first conversation, which were followed up for at least three months and assessed overall survival into second in the two treatment arms for futility.
As you recall overall survival is a primary endpoint also open study the call Micky has recommended to try to continue as planned.
When the company blindly reviews response rate data in all Tri Party expense that is in the treatment and control ropes combined.
We continued to observe a high response rate of over 50% off that Daltile Evaluable patients. These high response rate is of course encouraging as well.
[noise] recruitment into almost study is proceeding well in spite of the coffee 19 pandemic.
Overall, the pace of recruitment is in line with our initial projection and even slightly better steel to father expedite the developmental CB 111 were currently getting ready to expand the overall tried to additional geographies.
We should provide additional update on all violent and studied advances. The next spring you don't think DSMB Siri view into all of a study is expected as planned in the first quarter of 2021.
We are excited to advance baby 111 for the potential benefit so far in cancer patient and would like to say.
All the patients and their families as well as a investigators and health care professionals, who are taking part in this important ongoing study.
Turning now to our mostly due to program. We are conducting two parliament drug development programs that are exploring the potential for must be too.
<unk> team, which we identified as a care a story of sale multi Ricky and as a therapeutic target for inflammatory diseases and cancer.
Our proprietary antibodies targeting most could you do have potential for treatment of various inflammatory medications.
And we are advancing our lead candidate VB seeks a $1.90 in June we submitted a pre I'd application for the F.D.A., which is currently under review by the agency, we expect to start toxicology studies in the fourth quarter of Twentytwenty.
And first in man study is expected in 2021.
[noise] and inflammatory disease in inflammatory disease, we presented new data and so you'll our 2020 meeting on the use of our I'd be most to antibodies as a potential treatment oh from onto it I tried.
We showed the treatment weighs on due mostly to antibodies significantly in a bit at our tried this progression in the call again into your small that'll help drive.
The treatment reduce disease severity by more than 50% and blocks father disease progression importantly in that advance Faisal fit disease.
The most speed to demonstrated higher activity, then anti TNF alpha the classical therapy on the market today with a 17 billion dollar market.
North America.
Actually I would not to go beyond preclinical results as they glass must be doing the crime scene in human disease, We show that biopsies taken from our eight patients show strong staining full must be didn't do anything flame joint which is another support the f. supportive.
Evidence for the clinical relevance of MOCVD tool in our rate.
I would not paying out right at two additional findings, we presented the Nash and pull like this and that the jets, Steve disease week or DDW Twentytwenty meeting.
Stuck in a study that was rate that in the top 10% or phone abstract in this category and was selected as foster off distinction.
Our that's a show the treatment with UNFI, mostly due to antibodies degrees inflammation and fibrosis international there and significantly reduce disease activity and it will likely small there.
[noise] in our second program on most speak to in oncology. We are studying by specific antibodies aim to kill tumor cells, having established that must be didn't do as a dog. It was expression is induced in multiple type of tumors. The most recent data.
From this program were presented in the late breaking session at the AC our virtual meeting in June.
Resolved, where from preclinical study in which we administrated our antibodies to animals that had the sloppy commit the static cervical and breast cancers.
We show the treatment ways, the bi specific antibodies to resolve that statistically significant improvement in survival.
The data also showed that our antibodies, maybe 18, killing of tumor cells by C. D. H T cells in a dose dependent manner and induced T cell activation in vivo.
To summarize as you can see significant progress has been made in both our creek programs.
Maybe 111 and must be too well keep you informed as additional updates come up.
I will now turn the call over to almost rone, our CFO to reviews, our financial results for the quarter I'm. Most thank you absorb.
Revenues for the second quarter, two covenant 20 were $158000 compared to one other than $68000 for the comparable periods in 2000 and might be.
Research and development expenses, some medical play grants.
Research and development expenses net worth approximately 4.9 million those for the second quarter.
Compared to approximately $3.7 million in the comparable.
You are those two adult than it might be.
The increase in research and development expenses net is in the second quarter was mainly related to the increase is a must be too risky and a decrease in ziad growth.
Offset mainly by payroll related costs for share based compensation expense.
General and administrative expenses for the second quarter were $1.1 million.
Compose the 1.2 million those for the second quarter Frankie line.
Financial income net well the second quarter 2020 was approximately $3000 compared to approximately 132 Kelvin laws for the second quarter 2000, it might being the decrease was primarily.
It will unfavorable changes in the currency exchange rates.
Comprehensive loss for the second quarter was $45.8 million Hawkins Centsper share concluded we hope.
$7 million or 13 cents per share for the second quarter 2000 and <unk>.
As of June 32020, we had cash cash equivalents sold them bunk deposit.
Restricted bank deposits.
The $1.3 billion and working capital to 6.1 million goals.
Our cash position was enhanced during the second quarter by equity financings.
We completed in May.
Net proceeds were approximately $6.4 million.
We expect the tower cash some discrete willing to central them bunker.
Yes.
Would it be sufficient to fund those.
Oh operation.
And the capital expenditure requirements into third quarter.
Well then in 22.
For further details on our financials is true to form 6K filed with SEC.
We will know opens a coke questions.
Thank you we will now be can talk to your question and answer session.
I would like to ask a question. Please press star one on your telephone keypad.
Confirmation toll indicate your line is my question Q.
You mean press star Q, if he would like to move your question from the Q.
Participants using speaker equipment, it maybe necessary to pick up you had said before person is dark he's one moment, please while we pull for questions.
[noise]. Thank you. Our first question comes from the line a Kevin to year with Oppenheimer. Please proceed with your question.
Hi, guys listen congrats on a really encouraging uptake you know and although a few questions from me today.
No drug can you remind us as to what triggers the next interim assessment in the first quarter 2021.
So actually and because they say hey registration trial, and we are talking about 400 patients and of course, it's not a short trial. So the SMC unless there is an urgent or some reason for them to me. We meet regularly every six months. So that's I mean twice a year each time.
In terms of TSMC meat, they not only looking at pay a safety results, which of course is a little are getting a very a detailed safety on the whole study, but they also look at then unlighted fashion on every endpoint. So if they're in the first.
The interim analysis. They looked at response rate, mainly with CA 125 in this entry May analysis. It was pretty plan. They looked at the overall survival because the first one was for efficacy and this one was.
Futility fourth a safety a off the patients from now on they are going to look at all day resorts, both for efficacy and for safety and they wouldn't get resolved as if we are at the end of the trial each time and of course, they will guide us if we should go.
Hey, According to plan or if there is there any alarm or any reason this demo safety or if there's any a major signal all fair and he can see and then of course there is always an ethical issue. If you do see if he can see should you keep on treating patients with placebo.
And therefore, they're going to actually meet convene every six months and guide US is there a.
Onshore and the steering committee, which is mainly wheeled from a gay people. If we should go with the trial without any modification.
Terrific. Thank you for that and with regard to.
The effort to expand the number of sites are I think you mentioned geographies as well can you, perhaps two things one remind us how many sites are currently open. They then to your general thought process in terms of your geographies and perhaps target number sides to open in the coming.
Yes.
[laughter] So right now we I believe me, Hey, opening and 65 centers, Doug don't get me on the exact number it might be 64 66, but we are having a almost all the centers that we are planning to have both the in Israel in United States and actually.
All the centers a are opened for recruitment and although we have the public 19 patient traveling to get to VB 111 to the centers, where they need to get it. So it's quite encouraging there a geography extension is mainly to Europe and to add Japan.
There are two good reasons to do it first to expedite.
The time that we are going to actually recruit patients and the second thing is of course for regulatory issues, both in <unk> and Europe and Japan.
Okay, because they'll say hall or do you today Colgate 19, we actually elected not to installed in Europe previously when they pandemic was really.
Quite bad there and right now we are working on it and the same me in Japan, but I can tell you that doesn't so we didn't open yet both Europe and Japan. We are actually ahead and beat of our plan on their equipment.
Perfect and then maybe just one last one from me if I may with regard to the six a one yeah.
Really positive to hear the path into central clinical development or 2021, do you anticipate or phase one program in healthy volunteers or you know in a patient population with with active disease and kind of after a lot or what what patient populations might make sense.
So we're still a debating they say show you all know that there is an option a two days to go directly to patients a bit more complicated and I believe that that say and and I'm not committing right. Now we will go first to healthy volunteers, because we would like to.
[noise] a study in a much deeper way they way our monoclonal antibody is working on the immune system and the easiest thing is to actually take healthy volunteer where they have and normal and healthy immune system and see what our at six or whatnot.
The body is doing not just to add monocytes migration, but also to all the function, which we know that.
And so far in example studies it doesn't do anything to add the functional say hey model side. It doesn't affect any he says will be sales, but it will be much.
And better understanding to do eat in vivo ores in human beings and as I was mentioning we stopped having some.
Evidencing humans from the studies that we were doing on the histology and hopefully we will show mode.
In human even before starting the phase one but a the idea is to start with a short study in healthy volunteer right now and then go to the indications that we will pickup.
Thanks for taking my questions.
Thank you very much.
Our next question comes from the line of Jonathan Nashvilles with Roth Capital Partners. Please proceed with your question.
Hi, Thank you hi, guys. Congrats on the progress and I was wondering what is the minimum survival delta between the groups that was required for a second interim success, you know progressing without modification.
[noise] next Sunday question, Jonathan and that it's not in the public domain, but do you all have to understand that we're talking very early in the study, although we already a recruited for they say hey analyses at quarter off the patient 100 patients, but it's only three months.
A follow up so which was mainly for safety and futility. So I don't want anybody to make a anything about a FICO see also survival at this point do you still early to call I believed that the next time, where the DSMC going to look at the data in six months from now and they would all.
I'd look at most probably about 200 patients so more and some of them, we'll have a very long a photo op that'll be the first meaningful time to look at signals of efficacy and therefore, we didnt disclose it and we don't want to actually mentioned and numbers.
Only think I can tell you that they.
Told us that we can go forward without any without any mine ore or major modification of the study.
Okay, and then second interim that was triggered solely by greater than or equal to three months for at least 100 patients and had no minimum requirement whatsoever for desktop right.
Yeah.
Can I assume that you did not get any blinded information regarding survival in patients that had a fever nothing like that right.
Oh of course, not we're not going to get any blinded information from now on this is registration a blinded and got a blanket that of course, we do get I.
I may say understand your question, yes, we do get a blinded data on a survival, we do get blinded data on responds rate, we do see the blind the data because as you know everything right now is on his Crs.
And the blinded data is actually and something that we do see.
How are we going to talk about the blind to that that we wanted to separate the completely from and the de SMB or DSMC recommendation. So we to be clear to everybody is that the SMC didn't disclose any on blinded data to us so when I talked about response rate.
The blinded that doesn't the only thing I mentioned today, we have more information on the other a endpoints of the study but of course, each always quite risky to talk about blinded data.
Okay. So you were.
Referring to meet the maintenance or very high response rate you know quote over 50% you didn't specify but can I assume you're still was used to referring you get 125 and not RECIST criteria.
When I talk about over 50% it was a c. I want to 25, because that's what we add disclose before but we also seeing there a resist response rate as well and they will take the opportunity to talk about Pete.
I would say in the near future.
Okay, lastly, or the timing for the GBM and the colorectal initiation is is that it is still very difficult because of the I guess t. nature, where do you how to handle that.
[noise], so actually we are really on truck.
They're in both studies, although you can imagine that to stop the study and then the middle office pandemic.
It's not simple and many times, it's even at differ it's completely but that's not the case here, but I prefer to talk about eight when we as a first patient team and we when we will have the first patient theme, we will announce it.
But they really are.
Thank you very much on.
As a reminder, and he would like to ask the question Press Star one on your telephone keypad.
Our next question comes from the line Swayampakula Ramakanth with H.C. Wainwright. Please proceed with your question.
Mr. Ramakanth your line is lot.
Okay.
I apologize I'd been [laughter].
And then drawer and the most.
I've been something between called and if I'm going to us something which has been already answered I apologize for that too.
A couple of quick ones HM.
In your remarks, you mentioned about increasing the are expanding the study into certain additional geographies, Florida all outside.
So could you comment a little bit on HM.
It does the need for that.
According to succeed behind expanding.
Is it more for registration purposes into other geographies.
[noise], so actually when we decided to do it it was there for a very good reason boasts Jorge getting good recruitment told their trial and meeting the timeline and of course for registration a right now they're recruitment is going very well.
Nevertheless, I think it will expedite the recruitment and it's very important for registration. So we have both reasons in our mind.
And then regarding the most PD two programs.
At this point walked out additional preclinical work do you need to do or are you can start designing.
Your phase one programs or no clinical programs.
So actually whoever familiar with that and the regulation I'll say, a monoclonal antibody development.
You always have a two meetings with agency. The first one is a pre I'd meeting, where you have to actually submit to them already Youre synopsis full day phase one clinical trial and error.
Hey, outline what type of development you want to have and we already submitted that to the agencies. We already have a level details about what we want to do in the phase one and what we want to do a later on of course exec dosing is it depends on the toxicology and the second thing you have to submit.
To the agency at this point is walk easy or toxicology plan you can actually skip this meeting if you want but then you come to an eye, Andy and meeting and he might be that the agency want a single will not think that.
You had a significantly enough pre clinical or or a toxicology studies. So we already submitted the old program to the agency I was saying that it's under review a we already and no.
The mood, let's say they think about it but I will disclose everything when we look at an official response from them.
The plan is to stop the toxicology in that hey upcoming quarter in Nash the forced Walter So you can imagine that we are in line with what we plan and then when you get to toxicology reports and everything done that's when you can they submit basically they hi, Andy does agency, but.
He wants me the first time that they see the whole thing because they already got Mostel cemetery out that they're going to see in there I and the except for those outcomes that talks going.
Thank you for that.
Last question from me is on on dual one [laughter].
That's right, but did not to use what's the status there how much how much of.
How much can you disclose publicly on on what's happening within that program that you look good collateral.
Okay. So you all the AD recall that we have a small molecules that we actually did you deal with one of the big fat companies and say a already we already met toolset milestones in the program and there because of the coffee 19, and I was saying.
Before one I'll say important trials you know the clinical trials in that these on any melting snow day on human being but they said trial was postponed because of 19, it's going to be down in one of the Ivy League or universities in United States.
And a I can they tell you right now.
That's it's actually a going to start are starting gave very soon so there was a little delay, but hopefully things will progress now very quickly.
Thank you Laura Thanks for taking all my questions.
Thank you very much our king.
Our next question comes online Jonathan Kreisman with Longbow Research. Please proceed with your question.
Hi, Andrew around them. So congrats on the developments around the old trial.
So I had a question or two around the most could you too.
Well you published a series of papers and presented some considerable preclinical Atlanta advancement achieved today.
There would be helpful. If you could share one of the next steps, we should expect them whether a these could include any commercial option and maybe some thoughts you have around the prioritization. Some of these programs. How you plan to approach the clinic and some timeline to think a realistic considering current environment. Thanks.
Okay. So hey, Jonathan Thank you for the a question.
In terms they'll say a.
[noise] coming milestones in there must be too I believe that the first and most important one would be there and discussion way the agency, which we are expecting to get soon and that's going to be an important milestone because that's basically going to reassure our program to where the a them.
Mark at the next stay very important thing will be of course. It took US ecology were also we have.
In two stages in these toxicology and we might be able to add disclose it but if we will keep on with the toxicology that should be a good day and assigned to them all kinds of what we do see so far is a very good otherwise of course, if there are issues in toxicology.
You always have to rethink about their program.
Everything Okay goes well, we're going to present more data on a.
A.
Multiple led a sclerosis quite soon there is a conference coming and hopefully we are going to present, they're important data, but I believe that say.
Relatively soon we will have some more evidence on the activity of small speedy to know Justine a animal models.
But also in things that are related to human beings and when will the had this we are going to actually at present it to the public and hopefully even have a key opinion leader in France talking about why they say hey programming, so unique and inflammation and I believe.
What I was saying today about they are hey, Hey, I just want to emphasize Elizabeth Elizabeth more about Pete and all these small deals in animal models you gave a.
A.
Anti TNF fine you do see response, but then when that is progressing technically a vein almost say completely or pathway with a must be too monoclonal antibodies. It's actually the opposite it's actually working on the Chronicity of all these diseases and even if the animal.
Can start developing the disease and maybe get too about.
Up to 30, 50% activity off the maximum disease. It you can get but then he just flourescent down for even subside because monocytes play a major role in chronic inflammation. So I believe that the next a year, we're going to come with more resolved.
Both in preclinical in some human ex vivo studies, it's we're doing with a toxicology and then of course, we die Andy.
Oh, but I'm just again on privatization and you have several of these programs.
Out there.
Any any thoughts around which ones you expect would progress earlier into into the clinic next year.
I believe that thing they they they'd be takes a one which is for inflammation he's going to be definitely there at first to go and not the bias to see think by specific as we all know it's more a complicated program and they in terms of 40.
Indication, we're going to look at first.
Hey, there is an option that we will pick up multiple sclerosis, as the first indication, but at the whole toxicology program is actually aim to the phase one phase.
Two way into B and there is no much different a in terms of they agency a regulation, which program. We are peaking so we are deferring. This decision right now as you can imagine whenever we can ways more resolved and this is completely different program from any other anti inflammatory process.
Brands on the market, we do get.
Questions interest discussion and of course will say a.
I would say.
Part of our decision where exactly to go of course, it where there is a neighborhood where there is I tried that you can achieve actually proof of concept relatively easily and they Walt is they need off the market in terms of say a option to get there yes.
But there is shape here because if it didn't didn't working in many different inflammatory indications that's going to be a huge problem.
Okay, great Thanks, and good detail.
We have no further questions at this time I would now like to turn the floor back over to management for closing comments.
So thank you all for participating in our call today.
And the.
Keepsakes.
It's very hectic time, thank you very much.
Ladies and gentlemen, this does conclude today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation and have a wonderful day.
[noise].