Q4 2021 Vascular Biogenics Ltd Earnings Call

[music].

Greetings and welcome to the V. B O Therapeutics full year 2021 earnings conference call. At this time, all participants are in a listen only mode.

and welcome to the VBL Therapeutics Full Year 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation.

A 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. As a reminder, this conference is being recorded. I would now like to turn the call over to Dan Ferry of LifeSci Advisors. Thank you. You may begin.

Once you require operator assistance during the conference. Please press Star Zero on your telephone keypad. As a reminder, this conference is being recorded I would now like to turn the call over to Dan Ferry of lifestyle advisors. Thank you you may begin.

Thank you operator, good morning, everyone.

Dan Ferry: And thank you for joining the VBL Therapeutics Full Year 2021 Financial Results and Corporate Update Call.

And thank you for joining the V. L Therapeutics full year 2021 financial results and corporate update call.

Dan Ferry: Joining me on the call is Professor Jorah Haratz, Chief Executive Officer, and Sam Backenroth, Chief Executive Officer of the Center for the Study of Human Rights. Thank you. Thank you.

Joining me on the call is professor John Hertz, Chief Executive Officer.

Stand back and Roth Chief Financial Officer.

Dan Ferry: a press release with the company's financial results was issued earlier this morning and is available on the investor relations page of the vbl's website at vbl rx dot com

A press release with the company's financial results was issued earlier. This morning and is available on the Investor Relations page of <unk> website at V. B L Rx dotcom.

Dan Ferry: Before turning the call over to Dror and Sam, 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.

Before turning the call over to Dror and Sam 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 provisions of the private Securities Litigation Reform Act of 1095 and section 21 E of.

Dan Ferry: Private Securities Litigation Reform Act of 1995.

Dan Ferry: Section 21e of the Securities Exchange Act of 1934 as amended.

Of the Securities Exchange Act of 1934 as amended.

Dan Ferry: As set forth in our press release, forward-looking statements involve risks and uncertainties that may affect the company's business and prospect.

As set forth in our press release forward looking statements involve risks and uncertainties that may affect the company's business and prospects.

Dan Ferry: 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

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.

Dan Ferry: Any forward-looking statements made on today's comments call speak only as of today's date, Wednesday, March...

Any forward looking statements made on today's conference call speak only as of today's date Wednesday March 23rd.

Dan Ferry: And the company does not intend to update any of these forward-looking statements to reflect events or circumstances that occur after today's date.

2022, and the company does not intend to update any of these forward looking statements to reflect events or circumstances that occur after todays date.

Dan Ferry: As a reminder, this call is being recorded and will be available for audio rebroadcast on our website. There will be a Q&A session following the company's prepared remarks. With that, I'd like to turn the call over to Professor George.

As a reminder, this call is being recorded and will be available for audio rebroadcast on our website.

There'll be a Q&A session following the Companys prepared remarks.

With that I'd like to turn the call over to professor Dror <unk> sure.

Thank you Dan and good morning, everyone.

Professor George: 2021 was a very productive year for VBL and the excellent progress we made both in the clinic and operationally set us up for further success in 2022.

2021 was a very productive year for VPN and the excellent progress we made both in the clinic and operationally set us up for further success in 2022.

Professor George: Our lead candidate, Ofravec, also known as VP111, recently completed patient enrollment and is now in the late stages of the OVAL Phase III Registrational Trial in platinum resistant ovarian cancer.

Our lead candidate <unk> also known as really 111 recently completed patient enrollment and is now in the late stages of the oval phase III Registrational trial in platinum resistant ovarian cancer.

Professor George: Recently, we also announced that the independent Data Safety Monitoring Committee overseeing this trial made a unanimous recommendation that the overall trial should continue as planned.

Recently, we also announced that the independent data safety monitoring committee overseeing this trial made a unanimous recommendation that the oval trial should continue as planned.

Professor George: We are expecting data readout on the progression-free survival primary endpoint from this trial in the second half of this year. If successful, this will be a transformational event for VBL, as it would position us to get ready to submit a BLA in ovarian cancer, which we would expect to occur in the first half of 2023.

We are expecting data readout on the progression free survival primary endpoint from this trial in the second half of this year. If successful this will be a transformational event for Bbl as it put position us to get ready to submit a BLA in ovarian cancer, which we would.

Expect to occur in the first half of 'twenty to 'twenty three.

We have a number of other significant catalyst to look forward to this year, including clinical data into other high value cancer indications colorectal cancer and Glioblastoma. We have also recently successfully completed toxicology studies.

Professor George: We have a number of other significant catalysts to look forward to this year, including clinical data in two other high-value cancer indications, colorectal cancer and glioblastoma.

Professor George: We have also recently successfully completed toxicology studies for VB601, the first anti-inflammatory candidate from our novel MTT technology targeting monocytes to fight chronic immune inflammatory disease and plan to enter the clinic with this program in the second half of 2020.

For VB six who won the first anti inflammatory candidate from our novel MTT technology targeting monocytes to fight chronic immune inflammatory disease and plan to enter the clinic with this program in the second half of 2022 .

Beginning with <unk>, our first in class gene based approach to treating cancer, which is a highly differentiated in the oncology space.

Professor George: Beginning with Ofravec, our first-in-class gene-based approach to treating cancer, which is highly differentiated in the oncology space. Ofravec has a unique dual mechanism of action designed to combine the blockage of blood vessels formation that are required for tumor growth with an anti-tumor immune response that recruits T cells into the tumor microenvironment.

<unk> has a unique dual mechanism of action designed to combine the blockage of blood vessel formation that are required for tumor growth with an anti tumor immune response that recruits T cells into the tumor microenvironment.

Professor George: Therefore, it has a broad potential to change the standard of care in multiple solid tumor indications.

Therefore, it is a broad potential to change the standard of care in multiple solid tumor indications.

Professor George: In addition to ovarian cancer, our lead indication, it has also shown objective responses in phase 2 trials in GBM and in thyroid cancer, and has been shown to have a good safety profile to date.

In addition to ovarian cancer, our lead indication. It has also shown objective responses in phase two trials in GBM and entirely to cancer and it has been shown to have a good safe profile safety profile to date in more than 300 patient in completed clinical trial.

Professor George: In more than 300 patients in completed clinical trials, we have not seen significant bone marrow toxicity or other concerning side effects. Importantly, it has a dosing schedule that is convenient for both the physician and the patient as it is administrated every eight weeks and is not expected to require any special monitoring.

We have not seen significant bone marrow toxicity or other concerning side effects importantly, it has a dosing schedule that is convenient for both the physician and the patient as it isn't ministrate at every eight weeks and is not expected to require at any special.

Monitoring.

Professor George: We were very pleased to announce earlier in March that OVAL, the phase 3 trial evaluating Ofravec in recurrent platinum-resistant ovarian cancer, is now fully enrolled with a total of 409 patients.

We were very pleased to announce earlier in March that awful the phase III trial evaluating <unk> in recurrent platinum resistant ovarian cancer is now fully enrolled with a total of 409 patients.

Professor George: We also announced on the same day that the independent Data Safety Monitoring Committee overseeing this trial made a unanimous recommendation that the trial should continue as planned.

We also announced on the same day that the independent data safety monitoring committee overseeing the strides made a unanimous recommendation that the fraud should continue as planned. This preplanned analogies is particularly important as a committee provided its recommendation.

Professor George: This pre-planned analysis is particularly important as the committee provided its recommendation following the review of unblinded data from 370 patients, which at the time represented more than 90% of targeted population of the tribe.

Following the review of Unblinded data from 370 patients, which at the time represented more than 90% of targeted population of the trial.

The oval trial is designed with two individual primary endpoint progression free survival and overall survival based on regulatory guidance successfully meeting either of these endpoints should be sufficient to support a BLA submission.

Professor George: The OVAL trial is designed with two individual primary endpoints, progression-free survival and overall survival. Based on regulatory guidance, successfully meeting either of these endpoints should be sufficient to support a BLA submission.

Professor George: Readout of the PFS primary endpoint is expected in the second half of this year. With a positive outcome in the PFS endpoint, we would expect to submit a BLA for FDA approval in the first half of 2023.

Readout of the PFS primary end point is expected in the second half of this year with a positive outcome in the PFS endpoint, we would expect to submit the BLA for FDA approval in the first half of 2020 through.

Professor George: 23. As a reminder, all of the other

'twenty three as a reminder, all of the other.

Professor George: Existing drugs approved for ovarian cancer, including POP inhibitors and Avastin, were approved based on PFS data, and they have not demonstrated an overall survival benefit to date.

Existing drugs approved for ovarian cancer, including PARP inhibitors, and Avastin were approved based on PFS data and they have not demonstrated an overall survival benefit to date.

Professor George: As we get ready for success, we had two important senior management hires recently.

As we get ready for success, we had two important senior management hires recently master it was due to the new created position of Chief commercial officer earlier, this year and some Bakken Ross as our CFO during the fourth quarter met will be responsible for.

Professor George: Matthew Trudeau to the new created position of Chief Commercial Officer earlier this year and Sam Beckenross as a CFO during the fourth quarter.

Professor George: Matt will be responsible for all commercialization activity around Ofra.

All commercialization activity around off of it he brings more than 25 years of U S and international experience commercially zing.

Professor George: He brings more than 25 years of U.S. and international experience commercially seen.

Professor George: complex biologic products and has worked.

Plex biologic products and has worked on all aspects of commercial practice at both small and large biotech companies both met and Sam will be based in the U S.

Professor George: on all aspects of commercial practice at both small and large biotech companies. Both Matt and Sam will be based

Professor George: I think it's important to see these appointments in the context of a broader strategic initiative to establish a U.S. presence for VBL and to prepare the company for future success in advance of the OVAL readout.

I think it's important to see these appointments in the context of our broader strategic initiative to establish a U S presence for ABL and to prepare the company for future success in advance of the oval readout.

As part of our strategy to increase awareness for off of it and the company in general we will be hosting a live in person K O L event in New York on Monday April 11th.

Professor George: As part of our strategy to increase awareness for Ofravec and the company in general, we will be hosting a live in-person KOL event in New York on Monday, April 11.

Professor George: The event will provide investors with the opportunity to learn more about Ofravec and the Ovarian Cancer space in general, and will feature presentations and panel discussions by three world-renowned experts in the field.

The event will provide investors with the opportunity to learn more about <unk> and the ovarian cancer space in general and will feature presentations and panel discussion by three world renowned expert in the field.

Speaker Change: Dr. Brantley Monk, Dr. Richard Benson, and Dr. Kathleen Moore.

Doctor friendly monk Doctor, Richard Penson, and Doctor carefully more.

Speaker Change: This is a timely event, given the upcoming PFS readout from OVAL and the increasing interest we are seeing in Ofravec from the medical community.

This is a timely event given the upcoming PFS readout for Marvell and the increasing interest we are seeing in off of it from the medical community.

Speaker Change: This will be our first in-person event for investors in over two years, so we are looking forward to seeing many of you there. You can find a link to register on the investor relations section of our website and also in the earnings press release that we issued this morning.

This will be our first in person event for investors in over two years. So we are looking forward to seeing many of you. There you can find a link to register on the Investor Relations section of our website and also in the earnings press releases that we issue.

Should this morning.

Speaker Change: I would like to remind the audience that Ofravec is also being evaluated in two other clinical trials that are expected to generate preliminary data in 2022.

I would like to remind the audience that offer that is also being evaluated in two other clinical trials that are expected to generate preliminary data in 2022. The first is a phase two clinical trial in combination with opdivo and immune checkpoint inhibitor for.

Speaker Change: The first is Phase II clinical trial in combination with Optivo, an immune checkpoint inhibitor for the treatment of metastatic colorectal cancer. It is being conducted under a cooperative research and development agreement with the National Cancer Institute.

The treatment of metastatic colorectal cancer. It is being conducted under a cooperative research and development agreement with the National Cancer Institute. The purpose of the trial is to see if off of ink can recruit the immune system into the GAAP environment, which b.

Speaker Change: The purpose of the trial is to see if Ofravec can recruit the immune system into the gut environment which behaves quite different than the rest of the body. The result will teach us if simple systemic dosing with Ofravec can turn the colorectal tumor immunologically hot and will help inform the company on whether this is an application we should pursue further in additional studies.

It's quite different than the rest of the body. The result will teach us if simple systemic dosing with all from it can turn the colorectal tumor immuno logically hot and will help inform the company on whether this is an application we should pursue father in additional studies.

The second is a randomized controlled phase two trial investigating offer Vic in neo adjuvant and adjuvant setting in recurrent GBM patients who are undergoing a second surgery. It is sponsor by the Dana Farber Cancer Institute in collaboration with a group of top notch.

Speaker Change: The second is a randomized controlled phase 2 trial investigating Ofravec in neoadjuvant and adjuvant setting in recurrent GBM patients who are undergoing a second surgery.

Speaker Change: It is sponsored by the Dana-Farber Cancer Institute in collaboration with a group of top neuro-oncology centers and enrollment is ongoing. We expect preliminary data from both the colorectal and GBM study later in 2020.

Oncology centers and enrollment is ongoing we expect preliminary data from both the colorectal and G. P. M study later in 2022 .

Yeah.

Speaker Change: Turning to our pipeline, we continue to make excellent progress with our monocytes targeting program and are on track to initiate the first inhuman study for our lead candidate, VB601, which aims

Turning to our pipeline, we continue to make excellent progress with our monocytes targeting program and are on track to initiate the first in human study for our lead candidate VB six one which aims.

Speaker Change: to offer a novel and differentiated approach to treat prevalent chronic

To offer a novel and differentiated approach to treat prevalent chronic.

Speaker Change: inflammatory diseases, such as multiple sclerosis, rheumatoid arthritis, stato-hepatitis, inflammatory bowel diseases, and others. VP601 is a monoclonal antibody that targets a receptor known as MOSPD2, the monowalk protein, and is engineered to prevent monocytes from exciting the bloodstream and traveling

Inflammatory diseases, such as multiple sclerosis, rheumatoid arthritis, statutory <unk> inflammatory bowel diseases and others, maybe six to one is a monoclonal antibody that targets a receptor known as more speedy to the mono walk protein and is engineer.

To prevent monocytes for exciting the bloodstream and traveling to.

Speaker Change: to inflamed tissue. Monocytes are believed to be one of the key cell types involved in inflammation and have been implicated specifically in the development of chronic diseases.

Two inflamed tissue monocytes are believed to be one of the key cell types involved in inflammation and ive been implicated specifically in the development of chronic diseases.

We believe our approach has a broad potential and is differentiated from the majority of current anti inflammatory agents, which work mostly through T. N. B cells, we have generated preclinical proof of concept showing disease modifying activity in animal models of multiple skirt.

Speaker Change: We believe our approach has a broad potential and is differentiated from the majority of current anti-inflammatory agents which work mostly through T and B cells.

Speaker Change: We have generated preclinical proof-of-concept showing disease-modifying activity in animal models of multiple sclerosis, rheumatoid arthritis, theatroid hepatitis, and inflammatory bowel disease, and demonstrated ex vivo activity of VB601 in monocytes isolated from patients with various chronic inflammatory indications.

Houses rheumatoid arthritis that type of therapies in inflammatory bowel disease and demonstrated ex vivo activity of VB six one in mono sites isolated from patients with various chronic inflammatory indication.

Speaker Change: We had a successful pre-IND meeting with FDA regarding our development plan for VB601. We have since completed IND-enabling toxicology studies that demonstrated favorable tolerability profile that support moving the product into the clinic. We are now conducting a GMP manufacturing run of VB601 and expect to initiate a clinical trial in the second half of this year.

We had a successful pre NDA meeting with the FDA regarding our development plan for V. P of six to one.

We have since completed IND, enabling toxicology studies that demonstrated favorable tolerability profile that support moving the product into the clinic. We are now conducting a GMP manufacturing run of 56 to one and expect to initiate a clinical trial in the second half.

This year.

To summarize with overall now being fully enrolled and with the TSMC unanimously recommendation to proceed following review of over 90% of the study population. We look forward to the PFS preliminary endpoint topline data readout in the second half.

Speaker Change: To summarize, with OVAL now being fully enrolled and with the DSMC unanimously recommendation to proceed following review of over 90% of the study population, we look forward to the PFS preliminary endpoint top-line data readout in the second half of this year and to transformational year for VBL in 2021.

This year and two transformational year for V. P. L in 2022 .

Speaker Change: I will hand it over now to Sam to discuss the full year financial results. Sam, please go ahead.

I will hand, it over now to Sam to discuss the full year financial results. Sam. Please go ahead.

Thank you Dror and good morning, everyone moved.

Sam: Moving to the financials, our revenues for the year ended December 31, 2021, were $0.8 million, as compared to $0.9 million in 2020. Total operating expenses for the year ended December 31, 2021, were approximately $30.4 million, consisting of $22.7 million in R&D expenses net and $7.7 million in general and administrative expenses.

Moving to the financials our revenues for the year ended December 31, 2021, or 0.8 million as compared to 0.9 million in 2020 total operating expenses for the year ended December 31, 2021 were approximately $30 4 million consisting of $22 7 million in R&D.

<unk> expenses, net and $7 7 million in general and administrative expenses. This compares with total operating expenses of $25 1 million in the year ended December 31, 2020, which was comprised of $19 7 million in R&D expenses, and $5 4 million in general and administrative expenses.

Sam: This compares with total operating expenses of $25.1 million in the year ended December 31, 2020, which was comprised of $19.7 million in R&D expenses net and $5.4 million in general and administrative expenses.

Sam: For the year ended December 31, 2021, VBL reported a net loss of $29.9 million or $0.45 per basic share as compared to a net loss of $24.2 million or $0.55 per basic share in 2020.

For the year ended December 31, 2021 V. L reported a net loss of $29 9 million or <unk> 45 per basic share as compared to a net loss of $24 2 million or <unk> 55 per basic share in 2020.

Sam: At December 31st, 2021, the company had cash equivalents, short-term bank deposits and restricted bank deposits of $53.5 million. Based on our current projections, we expect that this cash position will be sufficient to fund planned operating expenses and capital expenditures for at least 12 months from the date of the readout of top-line PFS data from the Phase III Oval Trial.

At December 31, 2021, the company had cash cash equivalents short term bank deposits and restricted bank deposits of $53 5 million based on our current projections. We expect that this cash position will be sufficient to fund planned operating expenses and capital expenditures for at least 12 months from the date of the readout.

Of top line PFS data from the phase III oval trial with that I would like to turn the call back over to the operator for the Q&A portion of this morning's call. Thank you.

Speaker Change: With that, I would like to turn the call back over to the operator for the Q&A portion of this morning's call. Thank you.

Speaker Change: Thank you. We will now be conducting a question and answer session. 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 question queue. You may press star.

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

You May press Star two if you would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys, one moment. Please while we poll for your questions.

Speaker Change: participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment, please, while we poll for your

Our first questions come from the line of Jonathan Aschoff with Roth Capital Partners. Please proceed with your questions.

Speaker Change: Our first questions come from the line of Jonathan Ashoff with Roth Capital Partners. Please proceed with

Jonathan Ashoff: Thank you. Good morning, and congrats on the timeliness of a lot of things. Can you please explain to us how this European Innovation Council accelerator thing works, and when you will get the money and have to issue those shares? And has any cash from that come in yet? The press really espouses the institution, but doesn't help me a lot with the nuts and bolts.

Oh. Thank you good morning, and congrats on a timely miss of a lot of things can you. Please explain to US how this European innovation Council accelerator thing works and when you look at the money and have to issue those shares and now has in paas from that come in yet.

Yes, Lee spouses the institution, but it doesn't help me a lot with the nuts and bolts of it.

Jonathan Ashoff: Sure. Thanks, Jonathan. This is Sam here. So, as you mentioned, we announced in December that we were awarded

Sure. Thanks.

Thanks, Jonathan This is Sam here, so as as you mentioned, we announced in December that we were awarded the 17 and a half million Euro a blended finance grant from the European Innovation Commission.

Sam: 17.5 million euro blended finance grant from the European Innovation Commission. 2.5 million euros of that is non-dilutive in grant form, and we expect to get the first part of that sometime during this quarter. In addition, as well, as you can see in the 20F.

Two and a half million euros of that is non dilutive and grant form and we expect to get the first part of that sometime during this quarter. In addition, as well as you can see in the 20-F.

Sam: The additional $15 million direct investment is something that has to go through a process, which we are working through right now, and we would expect likely within the next quarter to be able to go ahead and finalize the documentation and be able to bring that in. The understanding is that those are shares that would be issued at the market at the time of the signing of the agreement, so sometime during this quarter we would likely have that

The additional $15 million direct investment is something that has to go through a process, which we are working.

Working through right now and we would expect likely within the next quarter are to be able to go ahead and finalize the documentation and be able to bring that in.

The understanding is that those are shares that would be issued at the market at the time of the signing of the agreement. So sometime during this quarter, we would likely have that issuance.

Speaker Change: Okay, Sam. Thank you. Can you guys please describe for us the kinds of preliminary data we expect to see later this year from these two phase two trials? You know, any rough sense of patient number and endpoints?

Okay. Thank you can you guys. Please describe for us the kinds of clue preliminary data we expect to see later this year foods two phase two trials.

Any rough sense of patient number.

Endpoints.

Speaker Change: So the two preliminary data, it's Rolf speaking. Thank you, Jonathan, for asking the question. In the colorectal cancer, actually, we are looking to see the histology results.

So the two preliminary data and draw speaking well. Thank you Jonathan for asking the question in the colorectal a cubs her actually we are looking to see the histology and resolve also biopsies. We had on these patients before they were treated with <unk> and also.

Rolf: of the biopsies we had on this patient before they were treated with Ofravec and after they were treated with Ofravec alone and after they were treated with a combination of Ofravec and the immune oncology checkpoint inhibitor.

They were treated with alphabet Cologne and after they were treated with a combination of ultra Vic and our immuno oncology or checkpoint inhibitor drug and the idea is to see if indeed with a viral product like <unk> you can bring the immune system.

Rolf: And the idea is to see if, indeed, with a viral product like Ofravec, you can bring the immune system or T-cells, CD8 and CD4, into the colorectal cancer. If, indeed, we can do that, that would be a major step forward.

System or T cell C D. H C D four into the colorectal any cancer. If indeed, we can do that that would be a major <unk>.

A step forward for these very big deadly indications, because you know that about 90% of patients with Gi tract tumors, including colorectal they actually have what we call a completely cold tumors. There is no immune system to recognize the tumor and therefore, even if you try to treat them with checkpoint inhibitors.

Rolf: very big, deadly indications because you know that about 90% of the patients with GI...

Rolf: tract tumors, including colorectal, actually have what we call a completely cold tumor. There is no immune system to recognize the tumor, and therefore, even if you try to treat them with checkpoint inhibitors, nothing works.

Theres nothing were but if indeed like in other tissues as we show the net shown 18, a ovarian cancer and in preclinical and many other tissues, including lung and other you can drink. These T cells to the tumor then of course later on a trial that we show if a combination of all.

Rolf: But if indeed like in other tissues, as we showed it in ovarian cancer and in preclinical in many other tissues.

Rolf: including lungs and other, you can bring these T-cells to the tumor. Then, of course, later on, a trial that will show if a combination of Ofravec with a checkpoint inhibitor can be for the benefit of patients, or the 90% of the patients that.

It was a checkpoint inhibitor can be for the benefit of patients all but 90% of the patients that can do not enjoy from the whole field of new immuno oncology drugs. So this is a very important data that we are expecting to get if it's positive it's opening a big Avenue, both for us and for the payer.

Rolf: not enjoy from the whole field of new immune oncology drugs. So this is a very important data that we are expecting to get. If it's positive, it's opening a big.

Rolf: avenue, both for us and for the patient. If indeed, even with a viral product like Ofravec, you can bring it to the gut, then at least we won't spend time and time of patients in trying to do trials that actually don't work in the mechanism of action of Ofravec. So that's why it's a very important trial. And that's why the NCI actually offered to do the trial with us.

<unk>.

Indeed, even with the virus.

Product like offer that you can't bring it to that and got than at least we want to spend time and time of patience and trying to do trials that they actually don't work and the mechanism of faction of all products. So that's why it's a very important trial and that's why that's a N C. I actually offered to do the trial with us.

Rolf: So this is one part for one answer to your question. Regarding the

Just one a part for a one answer to your question regarding that.

Rolf: Recurrent GBM, you know, it's a randomized controlled trial and the first part of it is completely blinded and the patient are recruited when they already failed surgery, chemotherapy, thimudar basically, and radiation and now they progressed and they are ready to go to a second resection which become much more common in a GBM. And before that, a third of them are going to get a Ofravec as a new adjuvant and two-thirds are going to get placebo.

Regarding G. P. M. You know, it's a randomized controlled trial in the first part of it is completely blinded and the patient are recorded when they already failed surgery chemotherapy, temodar basically and radiation and now they progressed they are ready to go to a second resection, which become much more common in a.

G B M and before that a third of them are going to get a offer Vic is the new adjuvant and two thirds are going to get placebo and that of course, you will get to tomorrow or the doctors, who will get the tumor and we will be able to evaluate if indeed, we're bringing the immune system there and if we are changing the internet.

Rolf: And then, of course, you will get the tumor, or the doctors will get the tumor, and we'll be able to evaluate if, indeed, we're bringing the immune system there, and if we are changing the genetic of this disease. But this data we are not going to come with in 2022.

Sickle cell disease, but they start to we are not going to come with <unk>.

And in 2022 from that 0.1 of the patients are in three groups two of them getting off of it and want to thank them getting standard of care, but it's an randomized open label part of the trial and we are following the patients for six months PFS and OS when we will have enough pace.

Rolf: From that point on, the patients are in three groups. Two of them getting Ofrovec, and one of them getting standard of care. But it's a randomized but open label part of the trial. And we are following the patient for six months PFS and OS. When we will have enough patient and enough data, we can start talking if we are seeing the same signal that we saw in our successful phase two.

One thing enough that that we can start talking if we are seeing the same signals that we so in our successful phase two and what I mean is that we will be able to say what we do see in the six months PFS in these patients and I'll be more specific because I expected.

Rolf: And what I mean is that we will be able to say what we do see in the six months PFS in these patients. And I'll be more specific.

Rolf: Six months PFS in this population is about 10%. If we are seeing a much.

Six months PFS in this population is about 10%. If we are seeing a much bigger number of patients that actually getting to six months PFS as we were seeing it in our successful phase two we will know that actually we are repeating what we've seen in our phase two and actually that this drug is working.

Rolf: number of patients that actually getting to six months PFS as we were seeing it in our successful phase two, we will know that actually we are repeating what we

Rolf: in our phase 2 and actually that this drug is working in GBM. That's the data we are expecting as a preliminary data. Later on, when it's fully recruited, we will, of course, have six months PFS, OS, and the histology data. And if it's coming positive.

J P M. That's what that though we are expecting is a preliminary data later on when it's fully recruited we will of course have six months PFS OS and the histology data and if it's coming positive we will try to actually go and submit it for condition.

Rolf: we will try to actually go and submit it.

Rolf: conditional approval for recurring GPs.

<unk> approval for recurrent GBM.

Speaker Change: Thank you for that. Given that you've done the 601 IND enabling talk studies, I would like to ask you, when you start giving this to people, what are you going to be monitoring most closely for? What have you learned to look out for, having done those studies?

Thank you tour for that you know given that you've done this 601 IND enabling.

<unk> talk studies I would like to ask you when you start giving this to people what are you going to be monitoring most closely for you know what have you learned to look out for having done those studies.

Speaker Change: Okay, so actually we were trying to be quite careful when we were saying that the toxicology actually was favorable. Indeed, we were as we expected from the mechanism of action.

Okay. So actually we were trying to be quite careful when we were saying that the toxicology actually was favorable.

Indeed, we were as we expected from the mechanism of faction, we didn't see much in the toxicology. So there is nothing that we should look in a very careful way but of course, we are going to monitor everything.

Speaker Change: We didn't see much in the toxicology, so there is nothing that we should look in a very careful way. But of course, we are going to monitor everything as you normally do in a phase I first in men. And we are going to start with the low dose and increasing the dose. The most important thing, although it's in healthy volunteers, we are actually developed and we are developing more bioassays that will enable us to do not just the PK, but also the PD.

As you normally do in a phase.

One first in man and we're going to start with a low dose and increasing the dose. The most important thing although 18 in healthy volunteers, where actually developed and we are developing more bio assays that will enable us to do not just the PK, but also the P. D for this new drug and that's going to be funding.

Speaker Change: for this new drug. And that's going to be a fundamental part in every new trial that we will do in patients.

Mental part in every new trials that we will do in patients because we will be able not just to look for the a a blood level I'll say a drive but also to know if the drug is actually doing what we expect that they will do to the mono sites. So we would have bio assays that we look both on monocytes migration.

Speaker Change: because we will be able not just to look for the blood level of the drug, but also to know if the drug is actually doing what we expect that they will do to the monocytes. So we will have bioassays that will look both on monocytes migration and adhesion, because that's the way the drug is working, actually. Prevent migration and actually stuck, or prevent the monocytes.

In addition, because adhesion because that's the way the drug is working actually prevents migration and actually stuck or prevent the monocytes from work and if we can show that in the right dosing. We get there. We will know that took place a drug is working according to the mechanism of action and then of course, we can go to specific indications.

Speaker Change: And if we can show that in the right dosing we get there, we will know that at least the drug is working according to the mechanism of action. And then, of course, we can go to specific.

Yeah.

Speaker Change: Okay, and if you'll indulge me in just one more question, it just needs a nice monosyllabic yes or no. The 370 patient interim analysis, you know, unblinded, I just want you to say yes or no to this. Was it 100% safety and absolutely 0% efficacy, futility, or any analysis like that?

Okay, and if you'll indulge me in just one more question it just needs a nice monosyllabic, yes or no.

370 patient interim analysis, you know unblinded I just wanted to say, yes, or no to this was it 100% safety and absolutely zero percent efficacy or futility or any analysis like that.

Okay.

Speaker Change: The DSMC are very careful because they see everything in an unblinded fashion. And what we got for them is unanimously green light.

The SMC are very careful because we see everything in an unblinded fashion and what we got for them is unanimously.

Green light to go forward.

Speaker Change: Our interpretation is as good as anybody else.

Our interpretation is as good as anybody else.

Okay, Alright, thank you dror.

Thank you our next questions come from the line of Kevin Decatur with Oppenheimer. Please proceed with your questions.

Speaker Change: Thank you. Our next questions come from the line of Kevin DeGeter with Oppenheimer. Please proceed with your question.

Hi, Jerry this is actually Susan on for Kevin just a couple of questions from us.

Speaker Change: Hi, Dara. This is actually Susan on for Kevin. Just a couple of questions from us.

Susan: I wanted to know if we could get any additional color on the timelines and scope of commercial preparation in the U.S. You kind of gave us a little bit with the events in April , but you know, any more?

I wanted to know if we could get any additional color on the timelines and scope of commercial preparation in the U S. You kind of give us a little bad way.

The events in April but anymore.

Susan: Yeah, so this is Sam here. I'm not sure that we can give you any more color other than to say that, you know, we're really happy with the progress so far. And as you saw in early, early this year, we brought on Matt Trudeau, who's been, you know, fantastic hire for us and has the right pedigree and background in order to really go ahead and drive.

Yeah. So this is Sam here I'm not sure that we can give you any more color other than to say that you know, we're really happy with the progress so far and as you saw on an early early this year. We brought on match for Dow has been you know a fantastic hire for US and has the right pedigree and background in order, but really go ahead and drive you know.

Sam: you know, all the pre-commercialization activities that we need to do, the, you know, starting to look at global strategy, market access, you know, the logistics of taking the drug and getting it to the end users and ultimately building out the market research and, you know, so we're really, you know, pretty deep within that and we're doing the pre-commercialization activities as we prepare for really building out once we have the PFS data.

All the pre commercialization activities that we need to do the starting to look at global strategy market access.

The logistics of taking the drug and getting it to the end users and ultimately building out the market research and you know so we're really you know pretty deep within that and we're doing the pre commercialization activities as we prepare for really building out once we have the PFS data.

Oh, great. Thanks.

Speaker Change: And then just to follow up, do you anticipate the K-12 discussion will include more thoughts on expansion in ovarian or will it be mostly focused on the E. coli?

And then just a follow up do you anticipate.

We anticipate the cable discussion one more thought on expansion in ovarian.

Will it be mostly focused on the current study.

Yeah. So from the you know for the K O L event I mean, we think that you know we've brought some really good kols the table over here, it's going to be a great discussion both on <unk> as well as the market in general and there have been some some really great advances as we you know get towards our goal ultimately of.

Speaker Change: Yeah, so from the, you know, for the KOL event, I mean, we think that, you know, we've brought, you know, some really good KOLs to the table over here. It's going to be a great discussion both.

Speaker Change: you know, on Ofravec as well as the market in general, and there have been some really great advances as we...

Speaker Change: you know, get towards our goal ultimately of, you know, having better patient outcomes in platinum-resistant ovarian cancer where prognosis is fairly poor at the moment.

Having better patient outcomes and platinum resistant ovarian cancer, where prognosis is fairly poor at the moment I think the discussion knowing the people involved is going to be fairly lively and you know investors are welcome to go ahead and ask questions and certainly the kols over there would be the right people to answer them general market questions, but.

Speaker Change: I think that the discussion, knowing the people involved, is going to be fairly lively and you know investors are welcome to go ahead and ask questions and certainly the KOLs over there would be the right people to answer.

Speaker Change: you know, general market questions, but also their ideas as to...

Also their ideas as to you know.

Speaker Change: you know where we go from here i mean ultimately the oval trial is in uh... platinum resistant ovarian cancer later lines of therapy but our goal is not

Where we go from here I mean, ultimately the oval trial is in platinum resistant ovarian cancer later lines of therapy, but our goal is not.

Speaker Change: you know, really to stop there. It's really just a starting point. We do plan on moving into earlier lines, first-line maintenance for example, and we do plan on broadening the label to be able to go ahead and use with standard of care or other chemotherapies of choice.

Really to stop there, it's really just the starting point and we do plan on moving into earlier lines.

First line maintenance for example, and we do plan on broadening the label to be able to go ahead and use with standard of care or other chemotherapy of choice.

Speaker Change: Now, if I can add, there are two points here. One is, I don't know if you're familiar with it, but the guideline in the US right now for platinum-resistant ovarian cancer is first to try and put the patient on a clinical trial. Because basically, there is no treatment.

And then if I can add there are two points here. One is I don't know if you're familiar with it but the guidelines in the U S. Right now for platinum resistant ovarian cancer is first to try and put a patient on a clinical trials because basically there is no treatment in platinum resistant.

Of iron cancer, so coming with a new drug with such a novel technology is actually a big expectation for both the patients and the doctors and that's why it's important to have these kols event ahead of the data in high school the right questions. If indeed offer back is showing what we hope and expect that it will show in.

Speaker Change: So coming with a new drug with such a novel technology is actually a big expectation for both the patients and the doctors. And that's why it's important to have this KOL event ahead of the data and ask all the right questions. If indeed Ofravec is showing what we hope and expect that it will show in platinum-resistant ovarian cancer, that's going to be just the tip of the iceberg for this compound.

Platinum resistant ovarian cancer, that's going to be just that people say iceberg for this compound is going to go much beyond ovarian cancer because the mechanism of action is actually aim for many more solid tumors and we haven't leased Haynes and several objective responses in other indications.

Speaker Change: going to go much beyond ovarian cancer, because the mechanism of action is actually aimed for many more solid tumors. And we have at least hints and sub-objective responses in other indications.

Speaker Change: I'm looking forward to it. That's all from us. Thank you.

I'm looking forward to it that's all from us. Thank you.

Thank you.

Thank you our next questions come from the line of RK with H C. Wainwright. Please proceed with your questions.

Speaker Change: Thank you. Our next questions come from the line of RK with HC Wainwright. Please proceed with your questions.

RK: Thank you. Good afternoon and good morning.

Thank you good afternoon Dror good morning, Sam.

RK: A couple of quick questions, as you know there are multiple clinical candidates putting out late-stage data for platinum-resistant ovarian cancer this year, so keeping that in mind, you know, what sort of hurdle PFS do you see?

A couple of quick questions.

As you know.

Our multiple clinical candidates.

Put in Europe .

It's data.

For.

For platinum resistant ovarian cancer this year, so keeping that in mind.

What sort of.

Hurdle PFS do you do.

RK: do you think Ofravec needs to achieve so that you would feel comfortable?

Do you think offer erecting it's too cheap.

That you would feel comfortable.

RK: filing a regulatory application based on that data.

Filing.

Literally application based on that data.

So good morning, RK and thank you for asking this question first.

Speaker Change: So, good morning RK and thank you for asking this question. First.

RK: Usually, in general, I don't want to talk about other companies' products. I'm very careful about it, but for the sake of patients, any good drug that will work in platinum-resistant ovarian cancer, it will be a blessing.

And in General I don't want to talk about other companies a product I'm very careful about it but for the sake of patient any good drug that will work in platinum resistant ovarian cancer it would be a plus.

RK: And we all think about the patient as well. Having said that, when you talk about clinical significant PFS, it's not just a number.

And we all think about it as a patient as well, having saying that when you talk about clinical significant say a PFS. It's not just the number it's a multiple factors and actually its always in discussion with the agency. So with positive results. We are going to have much more than just PFS in the analysis that we're doing and why.

RK: It's multiple factors, and actually it's always a discussion with the agency. So with the positive results, we are going to have much more than just BFS in the analysis that we are doing.

We will.

RK: will present the stop line results. We won't present just BFS.

We'll present these top line results, we want presents just PFS and hopefully the results will speak for themselves and of course, then you have a meeting with the agency to discuss a BLA submission actually in writing in our discussion with the FDA, which we are not disclosing right now.

RK: and hopefully the results will speak for themselves. And of course, then, you have a meeting with the agency to discuss a BLA submission. Actually, in writing.

RK: in our discussion with the FDA, which we are not disclosing right now, we also agreed on what will be the discussion that we are going to have.

We also agreed on what will be the discussion that we're going to have with them.

Speaker Change: Perfect, thank you for that. And then in terms of the 601, getting into the clinic later this year, you know, can you give us?

Perfect. Thank you for that and then in terms of six so I'm getting into the clinic.

This year.

Can you give us.

Speaker Change: a decent idea of how large of a trial this initial study is going to be and anything at all on the design.

A decent idea of.

How big how large of a trial is this initial study is gonna be.

Anything at all on the kind of design.

Yeah.

Speaker Change: Yes, of course. So the trial is going to be by purpose in healthy volunteer.

Yes of course, so the trial is going to be by purpose in a healthy volunteer and we are going to actually as I was saying before trying to get to right bio SA for the trials that we will do with that and different indications and of course in this trial. We are hoping to get what is the right dosing I'm not sure that we.

Speaker Change: And we are going to actually, as I was saying before, trying to get the right bioassay for the trial that we will do with different indications. And of course, in this trial, we are hoping to get what is the right dosing.

Speaker Change: I'm not sure that we will get to the maximum tolerated dose. As I was saying, this drug is...

We'll get to the maximum tolerated dose as I was saying they say a drug is look to be extremely safe, but anyway. One have to be sure that we are not getting to any maximum tolerated dose and then of course you have to use an old one and if not we will have to see at which does we get too.

Speaker Change: look to be extremely safe. But anyway, one has to be sure that we are not getting to any maximum tolerated dose. And then, of course, you have to use a lower one. And if not, we will have to see at which dose we get to a good result.

A good evidence that we are getting the right PK and PD, how big is it it's going to be a couple of things in terms of patient, it's not going to be a big trial, it's going to be done in steps, starting with lower dose and then increasing it we are going to have a lot of biomass.

Speaker Change: evidence that we are getting the right PK and PD. How big is it? It's going to be a couple of tens of patients. It's not going to be a big trial. It's going to be done in steps, starting with lower dose and then increasing it.

Speaker Change: We are going to have a lot of bioassays that we are going to do on fresh blood and fresh cells just to be

We are going to do on fresh blood and fresh sales just to be sure that it's not just safety that we are checking for but also beginning to see efficacy of this drug or at least.

Speaker Change: that it's not just safety that we are checking for, but also beginning to see efficacy of this drug, or at least.

Speaker Change: some prove that the mechanism of action is actually working in vivo in human beings.

Some proof that the mechanism of action is actually working in vivo in human beings.

Speaker Change: Thank you. I know you discussed.

Hum and I know you discussed.

Speaker Change: extensively on the colorectal and GBM studies, but these studies being done by collaborators outside of VBL, you know, how,

And extensively on the colorectal lung GBM studies.

But these studies being done.

By collaborators outside of.

B B L.

Oh, Oh Oh.

Speaker Change: Confident are you on the timing of able to release the data in 2022?

On the timing or be able to release the data.

2022 .

Speaker Change: Yeah, so we do feel very confident, but, you know, RK, as, you know, you probably have noticed, you know, the metastatic colorectal cancer results.

Yeah. So we do feel very confident but you know arc has as you know you probably have noticed the metastatic colorectal cancer results, which we originally expected in first half 'twenty two we've now broadened the guidance to full year 2022.

Speaker Change: which we originally expected in first half 22, we've now broadened the guidance to full year 2022.

Speaker Change: And the reason for that being is not because we don't expect the results here in the near term, but it is, as you mentioned before, these are, you know, third party studies and we're relying on the timing, you know, for those external third parties.

And the reason for that being is not because we don't expect the results here in the near term, but it is as you mentioned before these are you know third.

Third party studies and we're relying on the timing you know for those are external third parties.

Speaker Change: And it's one of those things where, you know, as we sit here late in the first quarter, you know, we know there's only about three months left. It could be a couple of weeks, it could be a couple of months until we get those results. So we wanted to just make sure that we had the guidance that fit within what we currently know today.

And it's one of those things, where you know as we sit here late in the first quarter. You know, we know theres only about three months left it could be a couple of weeks it could be a couple of months until we get those results. So we wanted to just make sure that we have the guidance that fit within what we currently know today.

Speaker Change: But we do expect to get those results here in the near to midterm and continue to move forward obviously with the, you know, GBM study as well and to the extent that there's any update with timing of that, naturally we will continue to update the market on those.

But we do expect to get those results here in the near to midterm them and continue to move forward, obviously with the GBM study as well and to the extent that there is any update with timing of that naturally we will continue to update the market on those things.

Speaker Change: And maybe, RK, I'll just add one thing. In the recurrent GBM, as we are talking about six months PFS, which all depends on the investigators that recruit the trial and the follow-up, enough follow-ups that we are getting. And when it is investigator-initiated trials, as you were saying, we cannot be 100 percent sure when exactly we are getting it. So we assume that it should be in 2022.

And maybe okay. I just had one thing in the recurrent GBM as we're talking about six months PFS. Each all depends on the investigators recruit the trial ends a photo op enough follow up since we're getting and when it is an investigator initiated trials as you were saying we cannot be 100% sure when exactly we are getting it.

Do we assume that it should be in 'twenty, two but in every investigator initiated trial it might be delayed by a couple of months or so so everybody should take it and with this way knowing that this is not completely in our control.

Speaker Change: In every investigator-initiated trial it might be delayed by a couple of months or so, so everybody should take it.

Speaker Change: with this way knowing that this is not completely in our

Speaker Change: Yeah, got it. Thank you very much. Thanks for taking my questions.

Yeah, Yeah got it.

You very much thanks for taking my questions.

Thanks, Mark Thank you very much.

Yeah.

Thank you our next questions come from the lineup so much ROI with Jones Research. Please proceed with your questions.

Speaker Change: Thank you. Our next questions come from the line of Somit Roy with Jones Research. Please proceed with your questions.

Hello, everyone and thank you for taking the question and congrats on the progress.

Somit Roy: Hello everyone, thank you for taking the question and congrats on the progress.

Speaker Change: If you could remind me, Dror, in the top line data for the oval.

If you could remind me a jewelry.

Oh in the topline data for the oval.

Dror: If you're going to look at the entire population, and then would you also present us in the subgroup by the mutation status or maybe the fewer subgroup, those would be revealed at the same time?

We hear you if you're going to look at the entire population and then would you also present us into subgroup by I don't know the mutation status or maybe just pure subgroup those will be revealed at the same time or.

Dror: If the ITD population fails, would you still do it? How are you thinking through presenting this data?

If the ITT population feels would you still do it how are you thinking through.

Presenting this data.

So of course, and this is a randomized controlled trial and they say look at the PFS. He told defense if he'd say coming positive we are going to see all the data and we're going to share. These data, including subgroup analysis in all of this of course, which is all pre plan.

Dror: So of course, this is a randomized controlled trial.

Dror: And this look at the PFS, it all depends. If it's coming positive, we are going to see all the data, and we are going to share this data, including subgroup analysis and all of this, of course, which is all preplanned.

Dror: If indeed the trial is not meeting its primary end point, which we hope that it will, and at that time we are looking at an interim look at OS, and if there is a good fair of chance to meet actually the OS, and you know that from the mechanism of action OS is very important with Alpha-Vec, we actually agreed with the agency that will keep on the trial, but then it's going to be in a blinded.

If indeed, the trial and is not meeting its primary endpoint, which we hope that it will and it and at that time, we were looking at an interim look at O S and if there is a good fair a chance to meet actually the O S. And you know that from the mechanism of faction OFC is very important. Please alphabet, we actually agreed with.

The agency that we keep all the trials, but then he is going to be in a blinded.

Dror: a fashion and then we won't be able to disclose any.

In fashion, and then we won't be able to disclose any numbers.

Speaker Change: Thank you. That's very helpful. I'm looking forward to the Q&A call.

Got it. Thank you that's very helpful. I'm looking forward to the theoretical.

Yeah.

Thank you. Thank you.

Speaker Change: Thank you. Our next questions come from the line of Jonathan Kreisman with Velour Research. Please proceed with your questions.

Thank you our next questions come from the line of Jonathan Kreisman with lower research. Please proceed with your questions.

Jonathan Kreisman: Hi Juan, so most of my questions have been answered, maybe if you could just...

I want so most of my questions have been answered maybe if you could just.

Juan: Provide more color on the final breakdown of patients in the OBALT trial, geographically or, you know, any additional criteria from the pool data, patient stage, histology, resistant versus refractory.

If I had more color on the final breakdown of patients in the oval trial geographically or you know any additional quite theories from of a cool data.

Patient they just go gee resistant or refractory.

Juan: Previous PARP treated patients, any data could be helpful, thanks.

Previous PARP treated patients.

That could be hum.

Yeah, I will try to be very careful not to disclose anything that its not in the public domain. So I can say is that this is a very difficult to treat population to start with just because of the indication we allowed up to five line of therapy. So we are talking about heavily treated population.

Speaker Change: Yeah, I will try to be very careful not to disclose anything that is not in the public domain. So I can say that this is a very difficult to treat population to start with because of the indication. We allowed up to five line of therapies, so we are talking about

Speaker Change: heavy-treated population, and we already disclosed that about 70% of them were a vacuum failure, and about 50% of them were a POP inhibitor failure, maybe even more than this. And we were disclosing that about 50% of them are what we call a platinum refractory, which means that they progress in less than three months after the last time that they were getting platinum.

And we already closed at about 70% of them were a vacuum failure and about 50% of them were a PARP inhibitor failure may be even more than this and we were disclosing that about 50% of them are what we call a platinum refractory which means that.

Progress in less than three months after the last time that they were getting platinum. So we didn't give ourselves any a discounts here I mean, we were taking the patient as they are in real life and we didn't select for any better population and it's very similar to what we've done in the phase twos.

Speaker Change: So, we didn't give ourselves any discounts here. I mean, we were taking the patient as they are in real life and we didn't select for.

Speaker Change: better population. And it's very similar to what we've done in the phase 2. So one can look at our phase 2 data and assume from there what we are expecting to see. Beside of that, I just want to remind everybody that we had a very important interim analysis after the first 60 patients. And we know that we have more responders, actually significant more responders, in the treatment arm. So we hope to actually.

One can look at that phase two data and assume format. There what we are expecting to see beside of that they just want to remind everybody that we had that very important interim analysis. After the first 60 patients and we know that we have more responders actually significant more responders in the treatment arm.

So we hope to actually.

Speaker Change: a get it a translate into the a primary and pointed we are looking for but I cannot disclose more

Get it.

Translate into the a primary endpoints that we are looking for but I cannot disclose more data right now.

Speaker Change: Maybe just geographically, if there's any breakdown you can provide in terms of the European patients and Japanese patients, from your patients altogether.

Maybe just geographically if there is any breakdown you can provide in terms of the European patients in Japanese patients.

Patients altogether.

Speaker Change: So most patients came from the U.S., and that's what the FDA expected, and that's what we did, and that's what it should be. In Japan, the PMDA actually insisted we will recruit at least 30 patients to this trial, and actually we were successfully recruited even a bit more. In terms of the rest, in Europe we recruited quite significant number of patients, and also in Israel. So it's all actually a real international trial.

So most patients came from the U S and that's what the FDA expected then that's what we did and that's what it should be in Japan. The P. M. D. A actually insist that we recruit at least 30 patients to this trial and actually weak and were successfully recruited even a bit more in terms of the rest in Europe , we recruited quite soon.

They've got a number of patient and also in Israel. So it's all actually a real international trial.

Okay, Great that's helpful. Thanks.

Speaker Change: Thank you. There are no further questions at this time. I would like to turn the call back over to Dror Haratz for any closing...

Thank you there are no further questions at this time I would like to turn the call back over to Dror for Roth for any closing comments.

So thank you all for participating in our call today and all of you have a wonderful day. Thank you.

Dror Haratz: So thank you all for participating in our call today, and all of you have a wonderful day. Thank you.

Yeah.

Speaker Change: Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.

Thank you. This does conclude today's teleconference. We appreciate your participation you may disconnect your lines at this time.

The rest of your day.