Q3 2020 Vascular Biogenics Ltd Earnings Call
Greetings and welcome to VBL Therapeutics third quarter 2020 earnings call.
At this time all participants are the listen only mode and question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad. Please note. This conference is being recorded I would now like to turn it over carpets to your host like a weighted with lifestyle.
Hi, there. Thank you you may begin.
Thank you operator, good morning, and thank you all from participating on today's third quarter 2020 results and corporate update for VBL therapeutics, leading the call. This morning will be professor Dror Harats.
Oh, VBL and I must run the Companys CFO.
Yes at least with the company's financial results became available earlier. This morning and can be found found on the investors page on the Companys website, if need be lrx dot com.
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 and the safe Harbor provisions on the private security gains on Securities Litigation Reform Act on Nike 95, VBL cautions that these forward looking statements and are subject to risks and certainties and could cause act.
<unk> results to differ materially from those indicated.
Any forward looking statements made on todays conference call speak only as of todays date from Monday November 16, 2020, and the company does not intend to update any of these forward looking statements to reflect events and circumstances that occur after todays date.
As a reminder, this called being recorded and will be available for audio rebroadcast on the company's website and as the operator mentioned all participants are currently and they listen only mode and they'll be a brick and they session. Following the company's prepared remarks.
I'd like to turn the call over to professor harassed CEO VBL.
Go ahead.
Thank you Mike and good morning, everyone. Joining me on today's call is almost zero and our Chief Financial Officer, who will discuss the third quarter Twentytwenty financial results [noise].
I'm pleased to say that it has been another productive quarter from VP and it was important developments and milestones for our lead program VP on 11, VP as unique gene therapy for solid tumors.
We are particularly encouraged by the ongoing progress with our phase three all volume evolved on the trialing of on cancer, which if successful and the potential to establish and use standard of care in a challenging disease settings, where patients currently have limited options.
[noise] on about it is and international placebo controlled double blind phase three potential registration study in recurrent platinum resistant ovarian cancer patients are being randomized to receive either a GPU on 11 or placebo on top of weekly Paclitaxel and which is just on.
And on top of care chemotherapy for this condition.
This study has been designed to enroll up to 400 adult patients and the primary endpoint is overall survival.
Despite a COVID-19, and they make recruitment and the Ole study is proceeding well and the pace of recruitment and it's now proceed on our initial projection there.
There are now almost 200 patient enrolled which is on how close it projected study population.
Earlier this year, we announced Salcombe free specified interim analysis that was conducted by the independent debt data safety monitoring committee or do you assume seat on the first 60 patients enrolled which demonstrated that the response rate and definitely be 111 treatment.
Was 58% or higher and this response rate impressively higher than expected for standard of care treatments for each response rate is typically between 10 and 20%.
Maybe on 11 is if I based on cancer gene therapy debt scanning Judas flu like symptoms Apone dozing, such seemed almost on not expected to wish chemotherapy and.
Patient, we supposed to treatment fever, which are likely to be on the VB 111 treatment. Their response rate was even higher 69%, which is of course encouraging their results were presented at the American Society of clinical oncology conference in June.
Why it is important to note that the study remains blinded were pleased by the steady exceptionally high response rate over 50%, which we continue to see in the total available patient population, which is close to 200 patients enrolled to date.
And you can see they all have tried continued to advance swell and the next periodic debt. Some siri view is scheduled to take place in the first quarter on 2021.
And another reason development on VB 111 was that we had non say initiation of a phase two study, which is evaluating a combination on VB 111, with nivolumab and immune checkpoint inhibitor for patients with metastatic colorectal cancer.
The study is being conducted on their at Rada agreement between the National Cancer Institute and Phoebe and.
Colon cancer is one of the most come on cancer worldwide, but so far on immune based approaches have been mostly on successful one possible explanation is that in Gi gastrointestinal cancer in general it appears to be less immunogenic.
The going on this phase two is to investigate where price English we do on 11 flow.
And old by the additional from Nivolumab main juice and anti cancer immune response. There are also plan to initiate and investigator sponsored studies, which debut on 11 for recurrent GBM and Dana Farber cancer Center, and other leading neuro oncology centers and the U.S.
[music].
We are also making excellent progress with our must be day two program in September we reached an important milestone when we had that free I and de meetings with after FDA will reach alignment on the clinic clunk of clinical development plan for VBL seeks a one which will be the first.
There are a point Dick monoclonal antibody candidate we plan to take forward from you on inflammatory indications. We are currently advancing VB seeks a one through I and de enabling studies aiming to submit and 90 application into second half on 2021.
Finally in October we were excited to announce that point debt appointment on small, causing as vice chairman of our board Mr., causing.
Where's transition to the role of charm and during Twentytwenty, one at which time doctoral Bennett Shapiro the car and chairman will step down, but we'll continue to sell on our board.
As we advance toward becoming and commercial organization and prepare for success.
These important way of bald members without proper York areas of expertise, Okay, and a half guiding the company to the next stage and they just don't causing have three decades of industry and consulting experience and has an exceptional track record on tapping biotech companies.
Many of you will know him through his association with the healthcare royalty partners and LDK, we're thrilled to have and take on this important role.
I will now turn the call over to analysts role and our CFO to review the financial results for the quarter Amos. Thank you.
And the news on third quarter two program frenzy.
Well 193 cells and dogs come from.
[laughter] 79 going on.
Compared with the year 2000, and <unk> and.
The increase from 100 and.
Yeah.
Research and development expense net were approximately $4.8 million well the food go through and compared to approximately three point they view on income.
On a comparable periods of 2000 and man.
General and admin.
And just a few expenses on third quarter were $1.1 million compared to $1.2 million from third quarter 2000 and <unk>.
Comprehensive loans this quarter was $5.8 million on that'd be sent.
Per share compared with 4.9 million going on.
Wilkinson for sure.
Well the third quarter 2000, and then.
And then just to see and felt that and went through with the cash cash equivalents. So income bulk four weeks and are speaker.
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[noise] 37.3 million go low.
And working cap income 30.7.
We expect that our cash and cash equivalents and Buck Bose.
We'd be sufficient to fund operating expenses and capital expenditure requirements and <unk>.
Third quarter, EPS can call and Wendy.
Okay and then.
And on our financial guidance for.
The form 6K and fine this year.
With that I'll turn things back to go free true well, the Q and they force on this afternoons call.
Thank you Neil if he would like to ask a question. Please press star one on your telephone keypad and come from if you don't want and they see your line is and the question Hill.
May press Star two if he would like to remove your question from the Hill.
And for participants using speaker equipment and may be necessary to pick up your handset before pressing the star teas.
Our first question is from Kevin did either with Oppenheimer. Please proceed.
Great. Thank you for taking my questions and congratulations on on all the progress with regard to enrollment for although I guess really maybe two questions from US today dry believe you and your prepared comments sided or pulled a response rate of about 50% and all from the first 200 patients can.
Can you provide a point estimate our exact a figure for that response rate and the number of patients and that's based on.
[noise] Yeah of course, thank you Kevin when we talk about the valuable patiently as you. All know we took about patients that have wait and see a 125 and.
Oh for at least a twice the normal day 11, which is both 17 its exactly what we did in the interim analysis and that's about 80% to 85% also patient accrual debt folder trials and of course, we are talking of patients that we have and at least two months follow up so that we can actually know each day sees a greater risk.
And so not a response and that actually not far from the two Andres I was a and talking about but one can estimate I don't want to give an exact number but it's at bolt on 100 and day and 50 patients already and I can tell you that your number right now is around 55% response rate for these.
Total population, which is even a bit higher on fold we've seen in the first day and 60 patients. So its a very steady very high response rates and we do see a index trial and now that we are a basically halfway recruiting from this trial. So we can actually conclude that this trial, we are going to have a high response.
Right now this is of course, a blind to try and so what I can talk about is a what we do see into total loans that population, but we already know from the interim analyses that its Wayne say quite nicely to the favorable CB 111, and why would that change now definitely moving from.
60 patient to 150, if steel we have the same very high response rate. So this is really encourage [noise].
Right, Okay for that and and then I guess I think our second question and just with regard to the on the SMB update and into first quarter and maybe two parts to the question first yeah was that shading towards your earlier in the quarter plus or the January timeframe or or perhaps later closer to to March and then you're just remind us as to you know what.
The you know either expected learning or are they on are the adaptive communication, you anticipate being up and provide to investors following that up there.
So of course the vs. A man C meeting games actually has plan due to every six months and it's going to be in the middle of the first quarter actually.
Right, Hey, exactly and the mail. So you can estimate exactly when it's going to be I don't want to say this specific dates for day A. I mean, because if he has some see never like to actually a heavy publicly disclosed that day to day on meeting.
I was telling you before thats, what they are looking and of course, you suppose safety, but not just safety at the low can get because he can see as well because day sees a survivor, Larry a tried and true all of us know that if and drug show survival benefit it's quite difficult to keep on and try and.
A although there are no rules to stop the trial early for free to see the DSMC insist to see all the data. So what they are going to see is its very and.
Thorough and data on safety, which they're getting every time, including all day essays A's everything and of course, they should come back last hopefully and say as we always go up and to do you see is quite the safe drug but also they are going to see it affords dot dot on the day primary endpoint, which is over on.
Survival and secondary April eight and point, which is PFS on that and the second secondary which is a response rate pocius resist and we see a 125 basically they are going to see data on all the patients recruited to that time, which is we expect to be of course over 200 patients and.
They are going to see the data and they're very similar to way that they are going to see the doctors and also try and what they are going to disclose.
Not that much actually because they we have to be blinded and we keep very careful to be blind and this is a pivotal trial. So far it's really a promising try because it's a very high response rate and nobody wants to Eric These trial in any way with the agency and therefore, most probably what we will be able to.
Say that they looked at the data and they gave us the green light to go on it's unlikely at that point that they will have enough data even if the drug is working and a very well wait to stop the trial early.
[music].
That's extremely helpful listen congratulations on all the progress thanks for taking my questions.
Our next question is from RK with H.C. Wainwright. Please proceed.
Thank you good afternoon, and drawer and name on since you already answered my questions on Oh, low and regarding the.
Going on at the cancer study.
Could you give us some additional color regarding the design and also and Ah, we could potentially see get debt plus look on the data.
This ends up and as an interim analysis.
So thank you and.
Okay. As you know this trial is done and together with day and.
Okay, and National Cancer Institute and.
And there and we are actually and recruiting patient ways.
Okay, and colon cancer from it to start the colon cancer, which are beyond the standard of care and therapy. So most of them failed chemotherapy and all of them already failed checkpoint inhibitors. I'll go you know the checkpoint inhibitors don't where occasionally and colon cancer and water. They are a getting through its actually.
And single open trial, where we are recruiting these patients are getting gas first biopsy, usually from them and the static leisure and aim to lever to show that indeed, there a tumor as well to be called and called two more that there is no immune and it seems to be involved in the door and we expect.
That would be and basically everybody there to recruit on day say a try and then day, we'll get on that same day. The first dose Oh, Hey, VB 111 tend to the therapy and viral particles.
Two weeks later.
And before getting day and next dose all three okay, and so getting the first dose of me Photomask. They will have their ill hop off then we'll have a second day biopsy just to show to give you on the 11 and loan is doing to the immune system and we know from biopsies. We did you know far and cancer and we should.
Expect to see the new system, there, it's a bit early but it's okay. Because we are going to have a third a biopsy [laughter] in that second week, they're going to get a new volume up and they're going to get the bottom up every two weeks.
While every six weeks they will get a combination of both Steve you on 11 and the volume up. So this way we are priming to bring the immune system into the tumor and that of course, we hope that the checkpoint inhibitor we activated.
The second half of patients that didn't get it biopsy a after they just may be 111 wait and get a biopsy just before.
Second dose of VB 111 to see what's the immune system reaction is through the combination of sleep you on 11 flow Sandy volume up. So we are going to actually look at these biopsies quite soon.
We estimate that by made Twentytwenty, one or sometime in the second quarter. We will have the first results that will tell us. If indeed, we are turning caught on cancer to become a hot tumor.
Okay. So.
And then at the time you do the biopsy really also be doing any biomarkers and then they'd be looking and any biomarkers. In addition.
And to the tissue.
And of course, the guy and to be a thorough investigation of the tumor, including [noise] genetic genomic broker on make everything.
Perfect and then on on most PD to.
What.
What I listen on work needs to be done you know before you get to file that Andy.
Or incrementally and indications and a second half of next year.
So actually for the I.N.V., we need to add to completely and toxicology and testing we are and doing it right now we already got preliminary results, which I'm not going to disclose but everything goes forward quite well and.
And of course, and where they are a making the batch for day and clinical trial. So we expect to submit and sometimes in the second half off 2021, and hopefully towards the end of the year, we will be able to start the study.
Perfect. Thank you. Thank you for taking my questions.
Thank you very much.
Our next question is from Sumit Roy with Jones trading. Please proceed.
Hello, everyone and congratulations on on that progress and.
A quick question on the overall trial.
Are you seeing given the very promising data from the second entry and then a person dream are you seeing any uptick and retail full enrollment or expansion and a number on site, that's and go live and give us and stuff how many sites currently enrolling the trial.
And the second is are you collecting data on four point.
Oh and be on Greencore, we'd 90, and if any of your patients are being tested and will that be present and separately or how is that being present that to be offended.
Sure. So first day to answer your first question, we have now 73 centers and most of them and United States.
And some of them in Israel and lately, we opened some meat and centers in Europe, and we are planning to open centers in Japan, a quite soon so actually it's going very well know trustee and recruiting and not just in the recruiting centers that are already are a cooking, but also in opening day and new centers.
And actually the vibes that we're getting from United States also centaurus, our portals Geo Gi organization. So we hear from day, a steering committee, which is mainly members of Geo GE is that things go very well and doctors are quite that please and we wont. They do see of course patients are tested.
For COVID-19, there were only if I recall right two or three patient that actually get GAAP infected with day coffee and 19, and I think that all of them stayed on the trial, but.
I'm not 100% true of all this information because we try not to get too much information from these blanket tried and then we have some <unk> issues. So I don't think that we will need to do and different a analysis for patients that were infected re scoping 19, it's only very minimal number of patients right now.
That's perfect. Thank you so much congratulations again.
Thank you very much.
Our next question is from Jonathan Aschoff with Roth Capital Partners. Please proceed.
Oh, Thank you very much growth.
Where the clinical trial with debone on that what results will you guys gene and successful enough to proceed with a further trials, what's the other bogey that you're looking for.
[noise] So of course, everybody wants to see some me and signals all fair and response in terms of Fay and resist I won't say in term of PFS and Oh, and when you talk about a small number of patients, but I think that's a major endpoints and we are looking for is actually giving a simple.
Systemic Ivy and fusion.
And change to more from a cold tumor to outdoor I'm sure that you're all familiar with and numerous studies done now we it's very complicated procedures injecting into the lesion and taking cells and educate them ex vivo and put them back into the tumor.
All of this is really a quite complicated with your local complication.
I think that even if you're just show that we can turn on color on contract were out to more and bring didnt and other immune cell there.
That would be good enough to actually make a decision to do and relatively small randomized controlled trial on the combination and the syndication even did we see more than 30 cents from signals.
And may be the right thing would be to do a bigger client right away.
Okay, and I can't see where I'd written down the Sars and it's time for many patients.
With simple okay. They the size and this trial is planned to be up to about 40 patients. It doesn't mean that we are going to go all the way to 40 patients. The idea is that after about eight to 10 patient, they're going to look and say and shiites on the biopsies and.
Actually get the first a result on a if the tumor is becoming their hopes to north and that the first a result that we are expecting in day.
Hey, Hey, Mead.
Twentytwenty one so right now a day a protocol talking about 27 patient, but they weakening crazy if needed and actually we can actually also increased it to other indications and G.I. If indeed, we do see and colon cancer that we took on cold tumor halt the planet and sea ice to extend it to other indicate.
Asian and <unk>. So the whole idea tells the story on the study you can call. It that teasing study to see if indeed, we are repeating what we have seen in April following on cancer, because you know far and cancer, it's quite clear and every biopsies that we're taking.
Including biopsies from Phase three where we are blinded, but we look at the biopsies just to see that they're done right.
A lot of inflammatory cells, and we know that that's not coming from patient plus chemotherapy. So we do okay. Maybe 111 does change cold tumors Hot.
Thank you for that and the 55% that you answered for response rate to the first question was simply trades and 50% blinded response rate and going up five for we'd be on 111 and downside for control right.
He said at a minimum and no no I I want to make it clear we were talking about over 50% in the totally blind that population and then he asked me if I can be more specific how much over 50% I was saying that at this moment, it's 55% for the total population.
But we all know that chemotherapy gave.
Gave a very or relatively low responds range and we already know from the entering.
That we had at least 58% response rate in the treatment on and 69% in the one that we know that are on VB 111, So we expect it to be much more than 55% into treatment though.
Okay. That's it and five is based on 150 patients you were saying well debt.
That's right.
Thank you very much true.
Thank you.
As reminder to star one on your telephone keypad. If you would like to ask a question will pause for a brief moment on for question.
Okay.
Our next question is from Jonathan Crazy and with Hillary Research. Please proceed.
Got it and your line is live.
[noise] drawer almost can you hear me.
Yes of course, we can here.
Okay. So we're beginning to see some encouraging testimonies on patient forums from women showed some positive outcomes from their enrollment and the old trial.
So while I acknowledge these are sporadic testimonies, if you will and the companies of course blinded to the results.
And these results do eventually turn out to indicate the higher awareness and PFS outcome either in the upcoming on next interim analysis, what kind of flow with some PFS thresholds or do you think would be required from the DMC to valuate stopping the trial and recommend the company to initiate a filing process.
So this question should be honest and this is DSMC I don't I told you, it's not pre specified and anyway, but I guess it well day, we'll look for to see is a statistical significant difference between the two.
And because they're getting a cup and Meyer cares so they wouldn't know and indeed, if it took care of separate and enough to show statistically significant which is for now for overall survival, each Oh 0.05 and for it and the PFS and as a secondary each again all point.
Oh, five deals unless and old 0.05, and a the hazard ratios that floor actually calculate it for something like that it's about Oh point.
A 65, so it's quite a good the hazard ratio. So I'm not sure. If you see it will be exactly on all 0.05. They will make these decisions, but you know day will never take a decision like that the loans usually there is a special meeting with the agency when something like that happened because [laughter].
Relative trial to flow to drag on the marketing and very difficult indication, but I can assure you that besides those ideas from seats, where we have a very strong steering committee and chaired by dR.A., Brad readily monk, which is at one of the later on GLG and they are monitoring the study and it.
Free care for ways, we are not rating by purpose. All these testimonials from patients were not allowed to do it as a company, but hey, the vibes that we get from day, and steering committee, which actually taking care of a lot of the patience and you can guess because geo GE is most of the centers there.
Quite optimistic.
Okay, Great and second question and most be too. So maybe if you could share some thoughts on how you're planning to approach clinical trials.
And Twentytwenty, one and whether you expect at this point to initiate the trials on standalone or partner with a sponsor a and what is the financing and planning and budgeting ahead of the clinical phase.
[noise]. So we are actually in our budgeting, we are calculating a all the expenses, including gay all the way to the end of phase one eight which is not going to be a big try and of course, you know that when you have such a novel technology and novel indicate.
And one has to be very careful and go from a low dose to a higher dose and that's the plan and the pace.
Okay, One day and.
And.
And if in day to results will be as expected.
And because they touch and although a two.
Type of therapy for immuno inflammatory diseases, and because we already have a very strong data and the preclinical work we assumed it at the certain point, we want developing to low.
But right now we are geared to develop week old and wait till the end of the phase one study.
Okay. That's helpful. Thanks.
Yeah, We'd said never a question answer session I would like to turn the conference back over to management for closing remarks.
So thank you all for joining us today on day school and we all hope to be able to tell more good news in the future. Thank you very much.
Thank you. This does conclude today's conference you may disconnect. Your lines at this time and thank you for your participation.