Q2 2021 Vascular Biogenics Ltd Earnings Call
[music].
Greetings and welcome to the P. P O therapeutics second quarter 2021 financial results and update call. At this time all participants are in a listen only mode. A question and answer session well that's it for my 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 will now turn the conference over because they have to be out do you think EMA.
To begin.
Thank you.
Morning, everyone and thank you for joining today's Bbl Therapeutics second quarter 2021 financial results and corporate update we did the call will be professor Dror Herrera, Chief Executive Officer, and Amos Ron Chief Financial Officer, a press release with the company's financial results was issued earlier this morning and is available on the investor relation.
Page of the company's website at V B L RF dot com.
Before turning the call over to management I would like to remind everyone that during this conference call forward looking statements made by management are intended to fall within the safe Harbor provision back of the private private Securities Litigation Reform Act of 1995 and section 21 E of the Securities Exchange Act of $19.34, as amended as set forth in our <unk>.
Release forward looking statements involve risks and uncertainties that may affect the company's business and prospects, including those discussed in our filings with the SEC, which include among other things our annual report on form 20-F.
These filings are available from the SEC or on our website any forward looking statements made on today's conference call speak only as of today's date Monday August six 2021, and the company does not intend to and intend to update any of these forward looking statements to reflect events or circumstances that occur after todays date as it were.
Minder. This call is being recorded and will be available for audio rebroadcast on the company's website.
It'll be a Q&A session following the Companys prepared remarks.
I'd like to turn the call over to the rest of Iraq. Please go ahead.
Thank you Eric and good morning, everyone. Joining me on today's call is almost Ron our Chief Financial Officer.
I'll discuss our second quarter financial results for 2021.
We continue to make progress in our clinical trials and registration, enabling phase III study of VB 111 in ovarian cancer.
The most significant events of the second quarter.
Protocol change a greater phone with a U S FDA.
Progression free survival was added as a primary endpoint to the original overall survival endpoint.
Successfully making either endpoint is expected to be sufficient to support a BLA submission.
The details of the change were described in her presentation at this year's <unk> annual meeting in early June and the accompanying press release.
Successful meeting of the progression free survival endpoint with the readout anticipated in the second half 2022 has the potential to accelerate the BLA submission by approximately one year compared to our original projections based on the readout of the <unk>.
For our survival primary endpoint, which remains anticipated in 2023.
In addition to potentially shortening the time for the anticipated BLA submission. The protocol changes have several positive implication for the oval trial and repeat one eleven's potential use as a treatment for platinum resistant ovarian cancer.
Including a second independent endpoint are risks that trial as we now have two shots on goal to obtain a result that will enable us to submit the BLA.
Second keeping the overall survival endpoint preserve the opportunity to differentiate in VB 111 from currently available ovarian cancer treatment, which were approved based on progression free survival data, so far and did not show an overall survival benefit.
As part of our discussion with the U S FDA CMC.
Industry manufacturing and controls growth. It was agreed that <unk> would provide additional data and to common patients on new batches to be used in the other study in the U S.
We submitted our request is material to the agency in early August.
And the CMC group is evaluating the debt that we sent them.
At this point, we do not have an estimated timetable on when we will hear back from the agency regarding their review.
In the meantime, we took precautionary step to reserve supply of FDA approved batches of VB 111 for U S patients.
We are being actively treated in the other study and in June we voluntarily paused enrollment of new U S patients.
Existing patients enrolled in the U S continue on protocol and enrollment continues in Europe, Israel and Japan.
Despite the temporary pause in U S enrollment, we maintain our expectations with respect to the timing of the PFS data readout in the second half of 'twenty 'twenty two.
Our next milestone for all valve is the upcoming DSM Sarath you expected this quarter.
This time. It will include review of 75% of the study population that is about 300 patients.
To date, we have had three successful TSMC reviews also study. The most recent one was in February of this year. Following their review, which looked at 200 patients to TSMC again gave us a green light to proceed as planned.
In the second quarter, we also significantly strengthened our cash position.
Earlier in the quarter, we closed a public equity offering at market price to raise net proceeds of $26.4 million from existing shareholder as well as institutional funds from the U S. Sandy's revenue together with the additional of $12.3 million.
That was injected into the company during the first quarter, mostly through the existing.
Of warrants that were issued in 2020, we now have more than $57 million on hand.
These funds are expected to cover the company until the year end 2023, which is beyond clinical readout in <unk> and the potential BLA submission of the VB 111 in ovarian cancer.
As we began prep.
Paris for success and potential commercialization of VB 111, we had a few changes to our board of directors. We are happy to welcome Alexander finger and Mike can rise to our board Alison was previously the Chief commercial officer at Bluebird Bio and has extensive experience.
<unk> and global product commercialization, including commercialization of gene and cell therapy products at Bluebird.
Mike has experience in health care capital markets will be critical to Bbl as we approach the disclosure of top line data from <unk> and as we plan to execute our strategic and operational objectives in bringing VB 111 to patients.
Finally, our planned succession for the chairmanship of our board was recently completed Marco Zinn, who joined our board as Vice Chairman last October is now our chairman Dr. <unk> stepped down as chairman, but will continue to contribute to <unk>.
As a member of our board.
Before I hand, the call over to our Chief Financial Officer, almost rone I would like to say that we have continued our momentum from 2020 into the first half of 2021 and are optimistic about the second half of this year.
We are encouraged by the significant investments of VB 111, and I look forward to sharing updates on our ongoing programs through the rest of the year.
With that I will hand off the call to Atmos, who will discuss the financial results for the second quarter. Thank you.
Thank you observed and good morning to everyone.
As of June 32021, we.
We had cash cash equivalents short term bank deposits and restricted bank deposits.
Totaling $57 million.
And working capital of $49.
Sure.
We expect that our cash and cash equivalents.
Optum.
Yes.
We will be sufficient to fund operating expenses and capital expenditure requirements until year 2020.
Revenues for the second quarter.
$188000.
First $150000 for.
For the comparable period in 2000.
R&D expenses net.
<unk> was $6.6 million for the fiscal year.
Compared to $4.7 million in the same period in 2012.
General and administrative expenses.
Was one $5 million.
Second quarter compared to one 3 million users.
Same period in 2000 and input.
And finally <unk>.
Comprehensive loss for the second quarter was $8 million or 12%.
Sure.
Two five.
Yeah.
<unk> 14 cents per share.
<unk> and the <unk>.
Comparable periods in 2000 and Flint.
With that I will turn the call back to the operator for <unk>.
Q&A for us.
Of this mornings call. Thank you.
Thank you if you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the queue you May press star two.
He would like to remove your lines and thank you for participating.
Speaker equipment.
May be necessary to pick up the handset before pressing the star is our first question is from there.
<unk> with Guggenheim. Please proceed.
Great. Thanks for taking question just.
Hum.
Sort of.
VB 100, Logan I guess first does the precautionary pause of U S patients does that change the nature of the update in the third quarter by the deal.
And I guess similarly with respect to the.
Investigator Glioblastoma trial, if there sort of any impact on that study sort of.
Concerning the batches.
For that study thanks.
Thank you Sir.
Actually the codes that we were.
Voluntarily took.
Not too.
Recruit new patients in the United States to screen for new patients in the United States.
<unk> was down mainly because we know that there are patients on the trial right now using the batches that are already approved by the FDA for this study and we don't want it to be in a position that the patient is responding to VB 111, and we know that some patients are actually staying on the drug for quite a long time and we have.
We'll be in a position that we want to have a supply to give to these patients and therefore, we voluntarily took this step but this step is not going to affect the TSMC review because of DSM CRE deal was cutting.
<unk> data was not affected at all by this and if any just when we announced to the centers that we are going to stop.
Greening you can imagine that they had a list of patients that they wanted to recruit to the <unk>.
And they actually recruited quite significant amount of patients so.
The review is going to be done of Abbvie.
Over 300 patients, which is about 75% of the page.
Patient.
Population of the trial regarding the other two trials that we're running the one that we're running with.
The Mci in colon cancer is not affected in any way by this.
The event because they have enough supply for what they need for the trial, but in the GBM trial. We also not screening for new patients because we just we're in a position that we were about to open more centers and we didn't want to open them before we know that we have.
The batches.
Prove to go now the drug is already in the U S waiting for the final approval from the CMC and the moment that we will get it we will be able to open deck bus recruitment for the overall and for the GBM trial.
Great. Thank you.
Our next question is from Kevin.
<unk> with Oppenheimer. Please proceed.
Hi, Good morning. This is Susan on for Kevin just a couple of questions.
Paresh.
Just a modeling question is the step up in R&D expense.
Good.
To last for the rest of year is at $6.6 million new baseline.
Can you repeat the question, we Couldnt hear you well.
Alright, let me let me try again.
In the R&D spend for the quarter or the new baseline for the remainder of the year.
Oh, that's cool.
Are you referring to the increase in R&D expenses for the quarter.
Yeah.
Yes, Okay. So we do not expect.
Oh.
This quarter.
Burn rate to continue for the full year.
We expect to be in line with.
Our average AUM for both.
$2 million or less per month.
Right.
<unk>.
The total R&D expenses for the year will be a bit higher than last year, because we are advancing.
VB six to one.
The Ole study is gearing up but.
Not in the portion that was evident this quarter.
Yes.
Thanks.
I'll follow up question on VB 111 enrollment so I think in June you guys get involved.
300 patients.
You provide an update on the number of patients enrolled.
We don't provide it.
On a regular basis, usually we provided when we get to.
Significant numbers, so I would prefer.
Not to say the number right now, but we keep on progressing of course.
We are not screening now in the U S. So the pace is slower, but we believe that we can actually if things would work well with the CMC, we will be able to meet the timeline of finish recruiting by year end or beginning of next.
Next year.
Great. Thank you.
And just one last question.
Uh huh.
Did the FDA provide any guidance on the review process and as my follow up to that is is there any kind of onsite inspection.
That might delay timeline.
No. We don't we don't expect any onsite inspection you you know that usually the onsite inspection is coming when you submit the BLA and of course it was.
The FDA wanted to know a lot of information.
In our case before we submit the BLA and I believe that one of the reason is.
Because we were shortening the time for a potential BLA, but it's all done in data that we are sending them and documentation there is no onsite AAV.
Is it the <unk>.
FDA actually guided us wide.
A thoroughly on.
What exactly they need to see in the startups that we are sending them and we believe that we send them. All this information at the beginning of the month, we know that they are working on it right now and reviewing it.
And we've been assured that they will come back to us.
At the moment that they will review this step.
Thank you that's all the questions right.
Thank you very much.
Our next question is from.
RK with H C. Wainwright. Please proceed.
Thank you good afternoon.
Most.
Regarding.
The cautionary pause that you're taking.
In the U S sites in terms of enrollment.
Hum do you.
Winning awards both commented you have on that.
Dennis.
The potential impact on the statistics.
And the and the population mix.
When you when you get to the final analysis.
A study.
I don't think Thats very good question, but I don't think that it will have an effect on the either the statistics all the overall population.
When we took this step we already had the majority of patients coming from the U S.
There won't be an issue of where the majority of patients coming from because you know that that's part of the things that the FDA will want to see and they know that the majority of patients coming from the U S.
Hey.
Second thing is that.
There is no real big change in the pace of recruitment because just before the suppose as I was saying before we had quite significant amount of patients that were screened so our plan was all of the time. Our statistical plan was all the time, assuming that we will be fully recruited by first quarter.
A 28.
22, and we because we knew that we're recruiting better than anticipated we were saying year end. So I don't think it would change any of the statistics will change any of the mix of population that we want to have.
Thank you for that and then.
Sure.
For the people that do it already recruited in the U S.
<unk> is the shelf life of the drug long enough.
In case some of these patients need to stay on the drug.
Other than anticipated.
Shelf lives that we have for VB 111, now if I recall right about five years, that's a very long shelf life and we don't have any.
The issue I believe it was a four and a half and we are extending it right now.
And we have no issue with shelf life.
And by the way we have no issue is production, we are making more batches and some of the batches will be already for the <unk>.
Commercial and.
Batches, all looks very well.
So it was only the issue of showing that new facility in the release lab are actually comparable to what was done in <unk>.
The other site.
Thank you for that my last question is.
Any commentary.
On the colorectal cancer.
Colon GBM studies.
In terms of the progress.
And also.
And any update on the timelines at all in terms of data expectations.
So the colon cancer is continue as planned.
And as you all know that we have.
Grid with a national country Institute doctors that we will actually look at the biopsies to see if indeed, we are attending the cold tumor of the column into a hot tumor, meaning that we have inflammation, there and a lot of CD four and CD eight cells for that we need enough biopsies, where the pace.
<unk> to our own VB 111 alone and when they are on combined therapy.
As you can imagine patients it's growing on trial like this at NCI are quite advanced in their disease, and we are collecting enough patients and enough biopsies for that and the moment that we will have it and that we will have data on the <unk>.
Histology of course, we will share it with the market. The point that the study is ongoing and the point that it takes time I don't think that that's a bad day.
<unk> and.
Signal, but.
I don't have more information.
About that.
Regarding the GBM trial.
Some centers are open some centers are ready to open but again for the sake of the patients that are on the oval trial, we didn't want to use any of the material.
That is already approved by the agency to use in the U S for clinical trials.
For any trial, except for the patients that are on the oval trial and getting VB 111, because they are a significant amount of patients that are actually on the drug and we have to make sure that we have enough supply for them.
Thank you and thanks for taking my questions.
Talk to you soon.
Thank you.
As a reminder, it is star one on your telephone keypad.
Like that's a good question. Our next question is from Sumit right with Jones trading. Please proceed.
Hi, Ben.
That's on the progress.
If you could just give us a little.
Color on what percent of patients are from the U S versus ex U S. Ex U S and how many sites are you.
As versus ex U S and.
Second is if you.
Do you have any idea on.
What.
The patients are.
What kind of treatment around the globe post <unk>.
Relapse.
And if there is a possibility of re dosing or stable patient if that's at all.
Mechanically it makes sense. Thank you.
Yeah. So.
Thank you Sumit for the question.
In the <unk>.
U S.
We have to.
Over 200 patients out of these 300 patients. So the majority are coming.
From the U S. There is no question about it they are.
About 64 sites.
In the U S alone. So we are talking about majority of sites coming from the U S. Can you imagine we also have a significant number of sites in Israel in Japan and in Nash.
And Europe, but the study was planned from the beginning to have the majority of patients from the U S.
What was your second question.
Does it make sense mechanistically to to be able to re dose these patients.
For our stable disease patients or.
That's that's not something you.
Because of the vector or antibody development on Hello.
No no actually are the antibodies does not prevent the drug from working because it takes about a year.
A few cycles of the drug in the blood to get into the endothelial cells and they just stay actually.
A quite protected in the gene is there for a very long periods of time and we showed it boosts in animal models and in human being when we had the chance to biopsies from tumors. The expression of the drug is a quite significant for a long period of time and we could see responses in recurrent dosing so.
There is no question that you can deviate in a recurrent dosing and actually that's why we are treating the patients every eight weeks until progression and we allow in the oval trial to actually create beyond progression until we're sure that this is real progression and not a pseudo progression and in the column study we.
Giving the drug every six weeks not every eight weeks. So we are giving the drug in has repeated dosing until the patients progressed when they progressed to.
So rapidly I think that what should be given is checkpoint inhibitors because may be one of the reasons theoretically that the patients will progress is that we induced immune system. There are royalties there, but then the checkpoint.
Inhibition by the tumor restart working but we cannot control it because it's not part of the trial of the oval trial. It is part of the call on study at the NCI, where we've combined it with checkpoint inhibitor. So if you asked me what the doctors do in the patients progress.
As far as I know they go in chemotherapy that drive to put them.
Sometimes a radiation, but there is no real treatment for <unk>.
Platinum resistant.
Aaron Council.
Got it. Thank you so much and congrats on the progress.
Thank you very much.
Thank you. This does conclude our question and answer session I would like to turn the conference back over to the BPL team for closing comments.
So thank you all for joining us on today's call and have a wonderful day. Thank you.
Thank you. This does conclude today's conference you may disconnect. Your lines at this time and thank you for your participation.
[music].
[music].
[music].
Good morning, everyone and thank you for joining today's B B L. Therapeutics second quarter 2021 financial results and corporate update we did the call will be protected Guajira, Chief Executive Officer, and Amos Ron Chief Financial Officer, a press release with the company's financial results was issued earlier this morning and is available on the inverse.
Relations page of the company's website at <unk> Dot com.
Before before turning the call over to management I would like to remind everyone that during this conference call forward looking statements made by management are intended to fall within the safe Harbor provision back of the private private Securities Litigation Reform Act of 1995 and section 21 E of the Securities Exchange Act of 1934 as amended as set forth in Europe.
Press release forward looking statements involve risks and uncertainties that may affect the company's business and prospects, including those discussed in our filings with the SEC, which include among other things our annual report on form 20-F.
These filings are available from the SEC or on our website any forward looking statements made on today's conference call speak only as of today's date Monday August six 2021, and the company does not intend to update any of these forward looking statements to reflect events or circumstances that occur after todays date as it were.
A minder that fall is being recorded and will be available for audio rebroadcast on the company's web site, there will be a Q&A session. Following the company's prepared remarks.
I'd like to turn the call over to Richard Horowitz. Please go ahead.
Thank you Eric and good morning, everyone. Joining me on today's call is almost Ron our Chief Financial Officer.
I'll discuss our second quarter financial results for 2021.
We continue to make progress in our clinical trial and registration, enabling phase III study of VB 111 in ovarian cancer.
The most significant events of the second quarter.
They all have a protocol change a great upon with a U S FDA.
Progression free survival was added as a primary endpoint.
The original overall survival endpoint success.
Successfully making either endpoint is expected to be sufficient to support a BLA submission.
The detail of the change were described in her presentation at this year's <unk> annual meeting in early June and the accompanying press release.
Successful meeting of the progression free survival endpoint with the readout anticipated in the second half 'twenty 'twenty two has the potential to accelerate the BLA submission by approximately one year compared to our original projections based on the readout of the <unk>.
For our survival primary endpoint, which remains anticipated 2023.
In addition to potentially shortening the time for the anticipated BLA submission. The protocol changes have several positive implication for the oval trial and we'd be 111, its potential use as a treatment for platinum resistant ovarian cancer.
Including a second independent endpoint are risks that trial as we now have two shots on goal to obtain a result that will enable us to submit the BLA.
Second keeping the overall survival endpoint to preserve the opportunity to differentiate in VB 111 from currently available in ovarian cancer treatment, which were approved based on progression free survival data, so far and did not show an overall survival benefit.
As part of our discussion with the U S FDA CMC.
Industry manufacturing and controls growth. It was agreed to CBL would provide additional data and documentation on new batches to be used in the other study in the U S.
We submitted our request is material to the agency in early August.
And the CMC group is evaluating that that that we send them.
At this point, we do not have an estimated timetable on when we will hear back from the agency regarding their review.
In the meantime, we took care of precautionary step to reserve supply FDA approved batches of <unk>.
111 for U S patients.
Existing patients enrolled in the U S continue on protocol and enrollment continues in Europe, Israel and Japan.
Spikes, a temporary pause in U S enrollment, we maintain our expectations with respect to the timing of the PFS data readout in the second half of 'twenty 'twenty two.
Our next milestone for all valve is the upcoming DSM Sarath you expected this quarter.
This time. It will include review of 75% of the study population that would be about 300 patients.
To date, we have had three successful DSM CRA views also study. The most recent one was in February of this year following very few which looked at 200 patients that the FMC again gave us a green light to proceed as planned.
In the second quarter, we also significantly strengthened our cash position.
Earlier in the quarter, we closed a public equity offering at market price to raise net proceeds of $26.4 million from existing shareholder as well as institutional funds from the U S and Israel together with the additional of $12.3 million.
That was injected into the company during the first quarter, mostly through the existing.
Warrants that were issued in 2020, we now have more than $57 million on hand.
These funds are expected to cover the company until the year end 2023, which is beyond clinical readout in <unk> and the potential BLA submission of the VB 111 in ovarian cancer.
As we began preparing for success and potential commercialization of VB 111, we had a few changes to our board of directors. We are happy to welcome Alexander finger and Mike can rise to our board and as Shaun was previously the chief commercial officer at Bluebird Bio.
And has extensive experience in global product commercialization, including commercialization of gene and cell therapy products at Bluebird.
Michaels experience in healthcare capital markets will be critical to Bbl as we approach the disclosure of topline data from mobile and as we plan to execute our strategic and operational objectives in bringing VB 111 to patients.
Finally, our planned succession for the chairmanship of our board was recently completed Marc or Zane, who joined our board as Vice Chairman last October is now our chairman Dr. <unk> Shapiro stepped down as chairman, but will continue to contribute to <unk>.
<unk> as a member of our board.
Before I hand, the call over to our Chief Financial Officer, almost rone I would like to say that we have continued our momentum from 2020 into the first half of 2021 and are optimistic about the second half of this year.
We are encouraged by the significant advancement of VB 111, and I look forward to sharing updates on our ongoing programs through the rest of the year.
With that I will hand off the call to Atmos, who will discuss the financial results for the second quarter. Thank you.
Thank you observed.
Morning, everyone.
As of June 32021.
We had cash cash equivalents short term bank deposits and restricted bank deposits.
Totaling $57.2 million.
And working capital of $49.2 million.
Yeah.
We expect that our cash and cash equivalents.
Some bumps proposals will.
We will be sufficient to fund operating expenses and capital expenditure requirements until year 2020.
Revenues for the second quarter.
$188000 as compared to $150000 for.
For the comparable period in 2000 and Flint.
Yeah.
R&D expenses.
Net was $6.6 million for the fiscal year compared.
Compared to $4.7 million in the same period in 2012.
General and administrative expenses.
Was $1 million to $5 million for the second quarter compared to one $1.3 million in the same period in 2000 and plan.
And finally.
Comprehensive loss for the second quarter.
$8 million or 12 cents per basic share compared to $5.8 million or 14 cents per.
Sure.
Sure.
Comparable periods in 2000 and slim.
With that I will turn the call back to the operator for the Q&A for us.
Of this morning Collyn. Thank you.
Thank you if you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the queue you May press star two.
He would like to remove your lives and thank you and.
There are parts of it.
Her equipment it may be necessary to pick up the handset before pressing the star is our first question is.
Excellent they're out with Guggenheim. Please proceed.
Great. Thanks for taking question just a couple on sort of.
The BD wanted to Logan and I guess the first.
Let me pause of U S patients does that change the nature of the update.
Third quarter by the deal.
And I guess.
Generally with respect to the.
Investigator Glioblastoma trial, if there's sort of any impact on that study.
Concerning sort of the batches.
For that study.
Thank you Sir.
Actually the pros that we were.
Voluntarily took.
Not too.
Recruit new patients in the United States to screen for new patients in the United States.
<unk> was down mainly because we know that there are patients on the trial right now using the batches that are already approved by the FDA.
This study and we don't want it to be in a position that the patient is responding to VB 111, and we know that some patients are actually staying on the drug for quite a long time, and we will be in a position that we want to have a supply to give to these patients and therefore, we voluntarily took this step by step is not going.
To effect the TSMC review because of DSM CRE deal was cutting day point date that was not affected at all by this and if any just when we announce that to the centers that we are going to stop screening.
Screening you can imagine that they had a list of patients that they wanted to recruit to the trial and they actually recruited quite significant amount of patients. So.
The review is going to be done off.
A bit over 300 patient, which is about 75% of the patient.
The population of the trial regarding the other two trials that we're running the one that we're running with the NCI in colon cancer is not affected in any way by this event because they have enough supply for what we need for the trial, but in the G. P.
<unk> trial, we also not screening for new patients because we just we're in a position that we were about to open more centers and we didn't want to open them before we know that we have.
The batches.
To go now the drug is already in the U S waiting for their final approval from the CMC and the moment that we will get it we will be able to open deck bus recruitment for their overall and for the GBM trial.
Great. Thank you.
Our next question is from Kevin <unk>.
They're with Oppenheimer. Please proceed.
Hi, Good morning. This is Susan on for Kevin just a couple of questions.
First.
Just a modeling question is the step up in R&D expected.
She left for the rest of the year is $6.6 million new baseline.
Can you repeat the question, we Couldnt hear you well.
Oh, sorry, let me, let me try again.
In the R&D spend guidance what are the new baseline for the remainder of the year.
So that's cool.
I refer you to the increase in R&D expenses for the quarter.
Yeah.
Yes, Okay. So we do not expect.
The current Oh, there this quarter.
Burn rate to continue for the full year.
We expect to be in line with the.
Coverage for both.
$2 million or less per month.
The year end.
The total R&D expenses for the year will be a bit higher than last year.
We are advancing the VB six to one.
The Ole study is gearing up but not in the portion that was evident this quarter.
Thanks.
I'll follow up question on VB 111 enrollment so I think in June you guys get involved.
Our 300 patient can you provide an update on the number of patients enrolled.
We don't provide it.
On a regular basis, usually we provided when we get to.
Significant numbers, so I would prefer.
Not to say the number right now, but we keep on progressing of course.
And we are not screening now in the U S. So the pace is a bit slower, but we believe that we can actually if things would work well with the CMC, we will be able to meet the timeline of finished recruiting by year end or beginning of next.
Next year.
Great. Thank you and just one last question.
Got it.
Did the FDA provide any guidance on the review process and as my follow up to that is is there any kind of onsite inspection.
That might delay timelines.
No. We don't we don't expect any onsite inspection you you know that usually the onsite inspection is coming when you submit the BLA and of course it was.
The FDA wanted to know a lot of information.
In our case before we submit the BLA and I believe that one of the reason is.
Because we were shortening the time for a potential BLA, but it's all done in data that we are sending them and documentation there is no onsite.
Is it the.
The FDA actually guided us wide.
A thoroughly on.
What exactly they need to see in the startups that we are sending them and we believe that we send them. All this information at the beginning of the month, we know that they are working on it right now and reviewing it.
And we've been assured that they will come back to us.
At the moment.
I will review these step.
Thank you that's all the questions right.
Thank you very much.
Our next question is from RK with H C. Wainwright. Please proceed.
Thank you good afternoon Dror.
Most of them.
Regarding.
The cautionary pause that you're taking.
In the U S sites in terms of enrollment.
Do you.
Where an award would come into do you have on that.
Dennis.
The potential impact on the statistics are in there.
Population mix.
When you when you get to the final analysis.
A study.
I don't think that's a very good question, but I don't think that it will have an effect on the either the statistics all the overall population.
When we took.
Took the step we already had the majority of patients coming from the U S. So there won't be an issue of where the majority of patients coming from because you know that that's part of the things that the FDA will want to see them. They know that the majority of patients coming from the U S.
Anyway.
The second thing is that.
There is no real big change in the pace of recruitment because just before the suppose as I was saying before we had quite significant amount of patients that were screened.
So our plan was all of the time, our statistical plan was all the time, assuming that we will be fully recruited by first quarter.
In 2020, two and we because we knew that we're recruiting better than anticipated we were saying year end. So I don't think it will change any of the statistics Corey will change any of the mix of population that we will have.
Thank you for that and then.
Paul.
For the people that do it already recruited in the U S is the shelf life of the drug long enough.
In case some of these patients need to stay on the drug longer than anticipated.
Satisfied that we have for VB 111, now if I recall right about five years, that's a very long shelf life and we don't have any.
Issue I believe it was.
<unk> four and a half and we are extending it right now but.
We have no issue with shelf life.
And by the way we have no issue is production, we are making more batches and some of the batches will be already for the <unk>.
Commercial and.
Our bedroom all looks very well.
So it was only the issue of showing that new facility in the release lab are actually comparable to what was done in Nash.
The other side.
Great. Thank you for that my last question is.
Any commentary.
On the colorectal cancer.
GBM studies.
So far the progress and also.
And any update on the timelines at all in terms of data expectations.
So the colon cancer is continue as planned and.
As you all know that we agreed with the National Cancer Institute doctors that we will actually look at the biopsies to see if indeed, we are turning the call to more of the column into a hot tumor, meaning that we have inflammation, there and a lot of CD four and CD eight cells.
That we need enough biopsies, where the patient to our own VB 111 alone and when they are on combined therapy. As you can imagine patients thats going on trial like this at NCI are quite advanced in their disease, and we are collecting enough patients. They may not biopsies for that and the moment that we will have it in that way.
We will have data on the <unk>.
Histology of course, we will share it with the market. The point that the study is ongoing and the point that it takes time I don't think that that's a bad day.
Yeah.
Signal, but.
I don't have more information.
About that rig.
<unk> the GBM trial. There is some centers are open some centers are ready to open but again.
For the sake of the patients that are on the oval trial.
We didn't want to use any of the material.
That is already approved by the agency to use in the U S for clinical trials.
For any trial, except for the patients that are on the oval trial and getting VB 111.
They are a significant amount of patients that are actually on the drug and we have to make sure that we have enough supply for them.
Thank you and thanks for taking my questions.
Talk to you soon.
Thank you.
As a reminder, it is star one on your telephone keypad, if he would like to ask the question. Our next question is from Sumit right with Jones trading. Please proceed.
Hi, everyone Congrats.
Congrats on the progress.
If you could just give us a little.
Color on what percent of patients are from the U S versus ex U S. Ex U S and how many sites are U S versus ex U S and.
Second is if you.
Do you have any idea on.
What.
The patients are.
What kind of treatment around the globe post relapse.
And if there is a possibility of re dosing in a stable patient if that's at all.
Mechanically it makes sense. Thank you.
Yeah. So.
Thank you Sumit for the question.
In the <unk>.
U S.
We had to have over 200 patients out of the 300 patient. So the majority are coming.
From the U S. There is no question about it.
Sure.
About 64 sites.
In the U S alone. So we are talking about majority of sites coming from the U S. Can you imagine we also have a significant number of sites in Israel in Japan and in Nash.
In Europe, but the study was planned from the beginning to have the majority of patients from the U S.
What was your second question.
Does it make sense mechanistically to to be able to re dose these patients.
You know as far as stable disease patients so are.
That's that's not something you.
You know because of the vector or antibody development won't allow.
No no actually.
The antibodies does not prevent the drug from working because it takes about a few cycles of the drug in the blood to get into the end hotel sales and they just stay actually.
A quite protected in the gene is there for a very long periods of time and we showed it boosts in animal models and in human being when we ended a chance to biopsies from tumors. The expression of the drug is a quite significant for a long period of time and we could see responses in recurrent.
Dosing. So there's no question that you can do it in a recurrent dosing and actually that's why we are treating the patients every eight weeks until progression and we allow in the oval trial to actually create beyond progression until we're sure that this is real progression and not a pseudo progression and in the column study we.
Giving the drug every six weeks not every eight weeks. So we are giving the drug has repeated dosing until the patients progressed when they progressed to.
We're rapidly I think that what should be a given is checkpoint inhibitors because may be one of the reasons theoretically that patients will progress is that we induced immune system. There are royalties there, but then the checkpoint.
Inhibition by the tumor restart working but we cannot control it because it's not part of the trial of the oval trial. It is part of the call on study at the NCI, where we combined it with checkpoint inhibitor. So if you ask me what the doctors do in the patients progressed.
As far as I know they go in chemotherapy they tried to put them.
Some time me and radiation, but there is no real treatment for a.
Platinum resistant.
Ovarian cancer.
Got it. Thank you so much and congrats on the progress.
Thank you very much.
Thank you. This does conclude our question and answer session I would like to turn the conference back over to the BPL team for closing comments.
So thank you all for joining us on today's call and have a wonderful day. Thank you.