Q4 2020 Vascular Biogenics Ltd Earnings Call

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Greetings, welcome to the vbl Therapeutics fourth-quarter and full-year earnings call at this time. All participants are in a listen-only mode a question-and-answer session will follow the formal presentation. If anyone should wage war operator assistance during the conference, please press star zero on your telephone keypad, please note. This conference is being recorded. I'll now turn the conference over to the VLT may be good.

Thank you, Molly. Good morning, everyone. And once again, thank you for joining us for today's vbl Therapeutics fourth-quarter and full-year 2020 Financial results in corporate update conference call leading him a call this morning will be Professor draw chief executive officer and almost Ron Chief Financial Officer a press release with the company's Financial results for the full year twenty-twenty off earlier this morning and is available on the investor relations page of our website at vbl RX before I turn the call over to management. I'd like to remind everyone that during this call for looking statements made by management are intended to fall within the safe harbor provisions of the private Securities litigation Reform Act of 1995 and section 21e of the Securities Exchange Act of 1934 as amended as set forth in the 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 Securities Law.

Exchange Commission, which include among other things our annual report on form 20-f. These filings are available via the SEC or on our website any forward-looking statements made on this call. May I speak only as of today's date March 25th, 2021, and the companies is not intend to update any of these forward-looking statements to reflect events or circumstances that occur after today as a reminder. This call is being recorded and will be available for audio rebroadcast on the company's website. There will be a Q&A session following Management's prepared remarks with that said, it's my pleasure to page to call over to Professor her ATS for

Thank you and good morning. Everyone joining me on today's call is our Chief Financial Officer will discuss the fourth quarter and full-year financial results for 2020. I'm pleased to say that it has been another productive water and ear for vbl with important developments continued progress. And it's changed my stones for our lead program. Vb-111 our novel gene therapy for solid tumors. We continue to be encouraged by the ongoing problem with our face oval devote on trial in ovarian cancer, which if successful has a potential to establish a new standard of care in a challenging disease setting where patients currently have limited options oval is an international possible controlled double-blind Factory registration, Choi.

Evening study in regard platinum-resistant ovarian cancer.

Today we had three positive reviews of the study. The first one was an interim analysis, which was conducted when we had 60 available page as we reported last March the analysis showed a ca-125 response rate of 58% or or higher for the VP One Eleven months later in August 2020. We reported that the data safety monitoring committee or dsmc after reviewing data off on one hundred patient had recommended the continuation of the trial is planned most recently in February 2021 during their most recent safety review am looking at two hundred patients the dsmc again gave us a green light to proceed after finding no safety issues. We look forward to the next Thursday.

Sincere review in the third quarter of this year. I'm pleased to say that looking at the blind that information with over two hundred patients in the data set. We continue to serve hi CA 125 response rate of over 50% in the total available patient population.

Enrollment in the oval study progressed. Well, despite the ongoing COVID-19 pandemic and in December, we announced that the first patient had been enrolled in the pac-ten of the study. We are thrilled to be expanding the study into Europe and soon to Japan as well. This expansion is expected to further generate our recruitment Pace diversify the patient population in the study and support our dialogue with regulatory authorities as I get closer to potential submission of a p111 for regulatory approvals. We expect to achieve full enrollment at the end of this year or in early twenties. We hope to continue demonstrating Vivian eleven potential as a safe and effective therapy for patient with solid tumors as oval and yep.

Their studies Advanced as you know, vb-111 has potential in solid tumor indications Beyond of our in cancer in our phase one and phase two trials. We have seen vb-111 drug activity in patient with thyroid cancer renal cell carcinoma narrow endocrine and other solid tumors wage, according ly we be 111 is currently being studied as a potential treatment for several other tumor types to that end. We recently announced that patient dozing has been initiated in the phase 2 clinical trial evaluating vb-111 for the treatment of recurrent glioblastoma or recurring GBE. The study is sponsored by the Dana-Farber Cancer Institute, and is being conducted through a collaboration between vbl and several leading neuron ecology Medical Center phone number.

in the United States the phase two study is currently enrolling patients with

Regarding GPM who are scheduled to undergo secondary century and vb-111 will be administrated either before and after surgery or after surgery. Only each arm of the study will be compared to a standard of care control arm.

Another investigator-sponsored study with VB 111 is being conducted by the National Cancer Institute or inpatient with metastatic colorectal cancer as we don't have any prior data in this indication the goal of this Phase 2 trial is to investigate whether priming with vb-111 followed by the Association of nivolumab may bring the immune system into this call tumor preliminary data from this trial are expected by meteor. We look forward to sharing more details about VP 111 and the oval study in particular at our upcoming virtual are indeed a on Tuesday April 6th.

We recently those the first patient in a randomized controlled phase two study with vp201 our proprietary investigational oral immune modulator model for the treatment of severe COVID-19. The purpose of this study is to test the safety and efficacy of baby too and impatient with severe COVID-19 and I look forward to providing additional update as trial is progress. We also continue to advance our VP 6-1 monoclonal antibody program enabling studies last part preliminary toxicology data, look very clean and we advancing production of GMP grade material, which would be needed for our IND submission that is expected in the first half of 2022.

Before I had the call over to our Chief Financial Officer almost wrong. I would like to say that 2020 has been a year of significant progress vbl. We are encouraged by the significant advancements with our Pipeline and we all look forward to sharing updates on the ongoing program through the rest of 2021. We look forward to speaking with you all again at our virtual are indeed a on Tuesday April 6th with that wage. I will hand off the call to amma's will discuss Financial result for the fourth quarter and full-year almost please. Thank you.

And good morning, everyone December 31st 2020. We had cash cash equivalents short-term deposits and restrict Bangladesh totaling 30.8 million dollars.

working capital of 24.5 million dollars

We expect that our cash and cash equivalents and short-term Bank deposits will be sufficient to fund the operation expensive operating expenses and capital expenditure requirements into the fourth quarter of 2022.

Revenues for the fiscal year two thousand and twenty. We're $922,000 as compared to $562,000 for the comparable period in 2019.

Research and development expenses net was Nineteen point seven million dollars for the fiscal year compared to fourteen point seven million dollars off the same. In 2019. The increase in R&D expense was mainly due to the development of the V6 one. Org General and administrative expenses was five point three million dollars for the fiscal year compared to five point seven million dollars in the same in 2019.

And finally comprehensive loss for our fully for the full year was 24.2 million dollars or $0.55 per share compared to June nineteen forty four million dollars or $0.54 per share last year with that. I will return the call back to the operator for the question off portion of this morning call.

And at this time we will be conducting a question-and-answer session. Our first question is from dr. Robert from HC Wainwright. Please proceed with your question.

Thank you. This is okay from Pennsylvania. Good afternoon. And thank you for this call and taking my questions a couple of couple of months once on the maybe one level in the overall trial. You know, you were talking about the next interim look in the third quarter of this year. So what are the criteria under which the dsmb will be taking is taking a look into the data and also took this interim. Look have any impact on the on the statistics on the statistical plan of the study itself.

Thank u r k for the question the dsmc is routinely looking at the unblinded data every 6 months that's part of the plan of this big study, which is a registration trial. They don't have any specific rules because otherwise we would have to pay a statistical price for that. But they are looking at the full data is if we are at the end of the trial, what do I mean by that? They don't just looking at safety they get of course all the same in an unblooded fashion to see that the drug is actually safe, but they also get the survival data including the kaplan-meier curves. They getting their progression you survival again, including the capital markets. They getting the resist response individually for every patient and comparing between the two arms and the same for Thursday.

125 so basically they do see the whole endpoints of the trial.

Vas for ospf a response rate by resist response rate by CR 125 and the combined response, right? And of course the safety they don't get the full life scenarios with a quality a life because they don't get this information at each point. We as a company see the full data also, but in fact that fashion, so we also get an understanding on the response rate posts by ca-125 both by resist. Of course, we both know who developed severe who did not but we are not allowed to speak about all these data because this is potentially registration. Try this try to put a bill a month for vb-111 and we have to be very careful having say that that there are no specific rules of course dsmc has some obligations which yep

Usually in this type of clinical trial especially when there is no other good treatment that can prolong life. So if they need to see significant Improvement in life expectancy or a major response in past they should raise a flag and then you can always request a specific meeting with their with their agency to make a decision if and when to stop the trial early, but there is no specific rule for that.

Okay.

Thank you for that. And then on the recurrent GPM studies, can you compare and contrast the current design versus the design that you have had met during the phase 3 trial the previous phase three trials because you are talking something about before and after surgery and I'm just trying to make sure I have it straight in my head. Okay. So off we had they're basically three that the third trial we are doing in recurring 2GB em the first phase 2 trial in regarding GPM. We primed we took patient that actually fell off a a surgery chemotherapy and radiation. They could have had actually already failed one surgery or even a more than one survey because you know that sometimes within 6 come back the patient go through a second surgery of debugging. But anyway, if they failed all of this then they would go on priming with vb-111 alone and then of course.

When they progressed or sort of progress because the drug is creating a demon sometimes it's sort of progression. We actually kept them on the 111 and allow them to get off their appease and many times. It was a avastin because of Washington play as a super steroid in the phase 3 trial that was randomized control one group got a vast amount of the other group got avastin together with 111 from day one, which was unfortunate as we published in couple of papers in her own College because of Austin actually blocked the expression of Phoebe 111 again, this was impatient that failed chemotherapy radiative therapy and surgery because we wanted to actually get information about the same population now in this phase two that we are running, but we also wanted to get tissue so that we can test for the month.

Sales and see if they are indeed coming into the brain in the same way that they are coming into the elysians environment cancer and to find out if there is a change in the home of the two more and because we know that many times when you use an immune driven drug or immune on ecology drug, it's important to give it when there is a tissue of tumor. We actually going for similar population, which is recurring GPM patient to felt surgery felt chemotherapy and failed regeneration. But now anyway they are going to go a second surgery as I was saying before that a lot of them getting a second debulking and now they are divided into three groups before surgery. Everything is blinded and randomize and group a will get VP 111 group dnce are going to get Placebo birth.

And of course we are going to look blindly to see if the drug has any.

Factor on the tumor biology after surgery. It's not blinded anymore group a that got the new therapies keeping on with adjuvant with you and eleven thousand rupees. It's called Placebo before is getting now vb-111 and Group C can go and any standard of care. So what are we doing from a study like this? We are comparing VPN 11:00 therapy to any therapy that is standard of care right now in regarding G p.m. But we also compared the new advent to an adjuvant therapy because we know the ecology it might be important to actually start the therapy when the tumor is there.

Perfect. How large of a study is this?

So it's actually not a very big trial. It's a small trial. We have fifteen patient any groups all together. It's 45 patients, but it's randomized blinded control file and we know that when you compare Thirty patients to fifteen in this indication, sometimes you can show even six months PFS and overall survival. So the dog idea is to actually have the surrogate marker as a primary endpoint and it's a secondary endpoint. We are having six months PFS and Os and if indeed we will show the positive cable end point and even a strong Trend in the secondary endpoint. There is a chance for a early registration for this drug in this actually extremely needed filled there is no new drug in GBM in the last twenty-five years. Absolutely. Absolutely. I get that then one last question before I step out of

The queue on the COVID-19 trials, you know, I understand you're moving outside of Israel into Japan and ended up dead. So what what is the bigger strategy for that, you know is and also there is there are so many other therapies which are which are being looked at for this COVID-19 patients. So how do you differentiate, you know your study versus what other guys are doing?

Okay, maybe I was misunderstood. We are extending the oval vb-111 trial to Europe and Japan and you can walk and why was bringing that International trial to put the drug on the market copy. Nineteen. We are running in Israel only right now and that's just an early trial to see if indeed the drug is having a a its effect on the COVID-19. What's unique about the VP to one is that it's working directly on monocytes my graduation and we know that the injury to tissues like the pneumonia the new car. Is and stuff like that is actually a monocyte driven a disease already showed in the past two one can actually block monocytes migration even in human being in one of our earlier phase two trials. So that's why we are testing it now the condition

In Israel right now is very good. You know that big proportion of the population world.

Immunize so now we have to actually do our thinking if you want to extend the the trial beyond the Israel or not right now. We don't have many new patients with COVID-19 Israel.

Thank you. Thank you for taking all my questions. Thank you.

Our next question is from Kevin degeeter with Oppenheimer. Please proceed with your question.

Hi, this is Susan calling in for Kevin degeeter. Thank you for taking my questions this morning. So I actually just wanted to follow up first on the 111 a little study environmental. Can you provide an update on the number of sites currently open? And then as a follow-up, what's your timeline for initiating sites in Europe and Japan you guys first. And it in August so it's been quite a few months.

Okay. So thank you Susan for the first question. Actually, we're all more than $0.70 now open internationally and I believe that it's changing every day. But I think that only three or four centers are not recruiting due to the COVID-19 right now, so we actually have almost all the centers open and we have them open a US Israel in Europe. It's right now in Spain and in Poland actually, it's seventy-eight centers that are open right now and in Europe, it's in Spanish in Poland and we intend to open centers in the UK very soon in terms of Japan and we will announce first patient dozing very soon.

It's going very well. They're well.

And then just a couple of questions on some other programs. Can you provide more color on the tox studies where the Moss TV to program and when an appropriate or what the exam then you to see this?

For the most be to toxicology studies. It's a formal toxicology study. We did the those ranging balls in rodents and in

Monkeys and each came completely clear so we could go to the in the hydros for a 4 weeks study Thursday. We already ended this trial as well and the results so far looks very clean, including the gross pathology, but we are waiting for the history month and for the final report because before we can report on this, but you can imagine that if we decided to pull the trigger and make the gym p a batch which is Thursday, you'll know quite costly it was after we've been reassured that basically there is no I would say anything that we can detect in the toxicology studies so far regarding the CRC trial, so I'm glad you asked this question because I want to clarify it off.

The audience and to the public correct answer is the biggest solid tumor oncology Market a 90% of the page there have what we call a call to more which means that there is no real immune system there and therefore they are not enjoying it all from the new checkpoint Inhibitors wage. And that's basically a major problem both for male and female. It's a high prevalent disease and it's not just a colorectal. It's a whole GI tract oncology, which is mainly calls to more they don't responds to checkpoint Inhibitors. Now, we don't have preliminary results in this month. So one can ask us why did you start the trial here and you didn't go forward with the thyroid cancer that we had very good preliminary results. So with renal or stuff like that, but the reason Thursday

That there is such a major need here and the NCI people came to us and offered to do this trial especially after this so that we can bring the immune system into of oranges to more and metastatic lesion. So I would say that this is a relatively early trial. I have no more knowledge on what we are not going to see than anybody else on this call or a or the doctors or anybody else, but we actually gave it a chance and this is a small trial. It's actually may not be funded by the National Cancer Institute. So there was a point to do it and see if indeed we can turn the color rectal cancer from a call to more to how to I wouldn't expect to see meaningful clinical results because we are taking a very late stage patient and it's a small trial. We already recruited the eleven patient to this trial.

so you can imagine that it's progressing well, but

I don't know if indeed. We are bringing the immune system into the colon cancer. We know that the biology in the GI for the immune system is completely different than in other organs. So it remained to be seen.

Great. Thank you for answering my question. That's all I had.

And before we take our next question, I would like to remind you that if you have any questions, you may press star one on your telephone keypad doing so will ensure that you do join the question-and-answer Q. Our next question is from Johnstown asked off with capital Partners, please we'll see what your question thank-you drawer does the recent rucaparib plus chemo phase 3 results alter in any way you're thinking about refractory. No varying cancer treatment.

Can you repeat on the trial that you referring to the recent rucaparib phase 3 - does that alter your thinking about life in any way? Not really. I'll tell you why pop innovators are important in violent cancer, especially in the office positive brca positive patients, which in Israel is quite prevalent because it's a prevalent in in the asking us to choose but in the world it's about 15% and we know that popping a Peters work and they working early and they work in later stage. So I'm not surprised at all. But when you think about pop innovators and you ask yourself why hello patient cannot continue taking the pump inhibitors, even when they have the bracket positive. It's because of a lot of side effects with the pump inhibitors, so I dead

Always believe that there is not going to be just one drug that will solve the problem in such difficult indication and I'm very happy for the patience for this trial but I don't think that it's really changing the landscape because if you look at what we have in our phase three awful trial seventy percent of the patients that we recruit and now, you know, it's not the final results. That's what we see so far are actually failure of a avastin and 50% are already failure of failed on pop Inhibitors so we can get very sick population that already felt almost everything and that's fine and I would expect that any trial with pop in a video will show some evidence I think of seeing this indication what disappoint me a little bit was when not for vbl, but for the patient in general in this ovarian dead,

Field is at some of the therapies when you look at survival, when you combine them with chemotherapy. Not just they don't do better on Survival. Sometimes they do even worse so I can tell you that the agency now, it will wants to see in any case before approval that your drug is not actually hurting survival and I believe 11:00 will do the opposite. Thank you for that. I was wondering is there anything you can say about fever and a ca-125 response rate beyond what you said the first interim in which I believe were sixteen patients with fever.

Yes.

So then it was 69% response rate and since then because this is a registration trial and because I can tell you that the interaction with agency is in a very serious way they look at it as how ready we are for the vla in all turns. It seems in everything we have to be very careful. The issue of fever is actually I'm blind some of the trial because 40% of the patients on 111 will develop fever and then the doctors and patients and everybody know that they are all the drugs. So we have been asked not to emphasize too much about what happened with the fever and that's why we are not saying anything as long as you can imagine, we do see it because we do see the data off and we do see the resist response because we do see the data and we do see the PFS in the total population and everything but we've been asked not to say a word about dead.

Okay, finally almost how should we think about the sg&a line over this year given that quarter-over-quarter doubling that we saw for the fourth quarter of 20?

Please repeat the question because we don't see doubling GNA.

Too cool to get to your annual numbers.

So this is just time shift between expenses all in all the gene expenses for the year very similar to to little the sporting Nets a 2096. Okay. Thank you guys.

Thank you.

And our next question is from Jonathan Friedman with Valerie research, please we'll see what your question.

Hi, thanks for taking a question. So you mentioned earlier that vbl 111 could be studied in additional modalities. So if you were to initiate an additional trial for vbl 111, besides the ones already running, you know, what will be the first indication that you would approach considering the specific data gathered to date.

Okay, so I think first one have to be focused on the indication which is lead indication and delete indication for VP 111 is off over and over and over and over area. And I think that they're we have preliminary very good data. We have a lot of data in biopsies. We know where we are. We have a interest in the Fate 3 and that's where we are concentrated and doing the trial. The reason we're doing two more tries is actually I believe the way we view the gas station has and the way that doctors actually approaching us and trying to convince us to do the right thing for the community and patient and that's why we agreed to do the package GPM a new trial which is actually run by the major centers in United States But there again, we have preliminary data and it was making a lot of sense to do the job.

trial because we knew what

Happening phase free in the colon cancer. I told you why we are doing it just I would say even more biologic questions than anything If Phoebe 111 can actually work off in the immune system in the gut because if it does then it's open a major way to treat patient in GI tract oncology, but I'm not sure that it will bring the other indications that we should go for. Definitely Islamic. We had the Institute working in the land. We know that the immune oncology is actually very important in the Lange. So that would be one thing liver and kidney liver metastases. We know the drug is working in the liver. We know that the I don't know there are also some small indications like thyroid where I believe it should be an investigator-initiated type of wage when the drug is on the market.

I believe that after having a positive trial that will show that will be 111 can actually make a big change in solid tumor. We will find a way to actually do a a trials in Powell in different indications other alone or with a strategic partner because that will be like a I would say as big step forward from what we know already own immune oncology because the checkpoint Inhibitors work only in about 17% of the

Bayesian because most tumors are called to war and I think that Fame of 111 is actually that we can turn these tumors into Autumn or where the school system is there and then you can combine it with different other immune oncology modalities and I'm saying it for you heard me saying a list of solid tumor that we already saw some dead a a indication that the drug is working there. But you know, there is a difference between different organs. Especially the GI tract is a completely different immune system. And so it's different.

Great and then following up on some comments you made today on potential Effectiveness on cancer. Um, so you mentioned that you know, it's a matter of biology and the mechanism of action of of the drug to actually be able to turn the music up to work in in the column like realistically, what would be the the threshold all the result you would be happy about in in this particular one.

So anything that will show that we can bring the immune system to the two more and recognize the two more that would be a major achievement. You know that in the GI. We have a bigger tolerance because we having all these new antigens coming from food. So it's not surprising that this is one of the coldest type of tumors and the question is if indeed by the mechanism we can bring the immune system there. So I'm not really looking for PFS heroes in this small very sick patients. We just want to see how the biome she's actually looks is it's similar to what we are seeing in the ovarian or not. And that will tell us if we need to actually invest much more in other trials in the GI tract or that this is not the right organ to actually treat with vb-111.

Okay, then on the V 201 in the COVID-19. So I guess the the molecule has been there for a pretty long time and I noticed it decided basically to initiate the clinical trial just recently whereas wage because truck more than 12 months ago. So I was curious to hear the thoughts behind the timing of of initiating the trial in this particular.

Well, it's going to be it's about history. The drug was developed in the beginning for a lateral sclerosis and indeed in a phase two trial in human being we could show that we can actually took them on all sides from getting into Auto sclerotic lesion, which was a primary endpoint of this trial but it's not really practical to develop an anti-inflammatory drug for a lateral sclerosis me that will actually you will need a very big trial. We tried it in other indication where it's more a T-cell type of inflammation and we saw some positive data boost. It wasn't strong enough to compete with the biologics and that's why we decided not to keep on developing it at that point. So when the COVID-19 start and after two or three months, it was quite clear that we have another monocytes driven disease and this is an acute disease and here we can show it relatively early the decision was wage.

We'll try to do a trial but for that we needed to go back and make the capsules and make the API and everything again, and we invested in doing this and not the moment that we had enough patience in Israel. We actually started the trial now. I think that this is a unique drug because of the mechanism affectionately can work in viral indication and I can assure you that even with solving the COVID-19 story. We will find the right Target in viral infection because it's quite clear now that the chronic infection in virus. Our involved diseases is actually a monocytes driven injury to tissues. It's not just COVID-19.

Four, okay be patient from the HIV itself, but they have a much shorter life a life expectancy because of chronic inflammation in a arteries in the vascular in general in the heart and other organs and it happened to be gained them on the Side Story.

Okay, thanks. And then lastly on the cash position. So you mentioned the the cash position now gives a company run away into a queue for 22. If you could maybe share some a bit more detail into into this office the guidance basically the prior one if I recall was for third-quarter 20 and and just trying to figure out the range of life that has been injected to the company and the last quarter.

Sure, so during the first quarter of 21, we had injection of 12 and 1/2 million dollars off from the exercise of warrants from ATM sales and from purchases by Aspire Capital LLC month. So this cash increased our balance and therefore we now have cash enough to take us into the fourth quarter of 2006. Does that address your question? Yeah, then if you could maybe just touch on how what percentage of the warrants issued back in May 2020 are still outstanding or if they have already been exhausted.

So about little less than half of the warrants was exercised in January and February and we have just outstanding about six video.

Okay, great. Thanks for the details.

And we have reached the end of the question and answer session now now turn the call over to the vbl team for closing remarks.

So, thank you all for joining us on our call today and have a wonderful day.

Thank you, and this concludes today's conference and you may disconnect your line at this time. Thank you for your participation.

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