Q3 2021 Vascular Biogenics Ltd Earnings Call
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Yes.
Good morning, and welcome to V B O Therapeutics third quarter 2021 earnings call.
At this time all participants are in listen only mode and please note that this conference is being recorded a.
A question and answer session will follow the formal presentation to join the question queue. You May Press Star then one on your telephone keypad should you need assistance during the conference call you May signal, an operator by pressing star and zero I would now like to turn the conference over to Erez from the V. B L team. Please go ahead.
Thank you operator.
Good morning, everyone and thank you for joining the email therapeutics third quarter 2021 financial results.
Great update call joining me on the call well first of all a lot Chief Executive Officer, and Sam Bakken Roth Chief Financial Officer.
The 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 IR <unk> com.
Unfortunately, Nicole wasn't boring 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 1995 and section 2021 E of the Securities Exchange Act.
74 is Amanda.
As set forth in our press release forward looking statements involve risks and uncertainties that may affect the company's business and prospects, including those discussed in our filings with the SEC, which include among other things. Our annual report on form 20-F. These filings are available from the SEC or on our website <unk>.
Forward looking statements made on today's conference call speak only as of today's date Monday November 15th 2021, and the company does not intend to update these forward looking statements to reflect events or circumstances circumstances that occur. After todays date. As a reminder, this call is being recorded and will be available for audio.
A rebroadcast level website, there won't be a Q&A session a photo of the company's prepared remarks with that I would like to turn the call over to Paul first of all Hot Dror. Please go ahead.
Thank you Eric and good morning, everyone. Joining me on today's call is send back and Walsh, our new Chief Financial Officer, who will discuss the third quarter of financial results for 2021.
We continue to execute on our development programs and strategic objectives and look forward to 2022, which we believe is going to be a transformational year for VPN we.
We expect to have data from multiple VB 111 clinical trials in a high value indications, including the progression free survival co primary endpoint from the phase III study in ovarian cancer.
We also anticipate beginning first in human studies evaluating VB six a one hour monocytes targeting antibody for the treatment of chronic immune inflammatory diseases.
Our overall clinical trial and registration, enabling phase III study of VB 111 <unk>.
Cancer has now enrolled over 85% of their targeted study patient population and we expect to complete enrollment in the first quarter of 2022.
So in the first quarter of next year, we expect to have another TSMC review, which will include <unk>.
That's a set of almost 100% if not 100% of the total study population.
The next milestone in the oval trial, we are looking forward to is the readout of the progression free survival co primary endpoint in the second half of 2022. This is particularly important and successfully meeting the PFS endpoint has the potential to enable us to submit the bill.
A one year ahead of plan compare to our original projections, which were based on the readout of the overall survival primary endpoint, which remain anticipated in 'twenty 'twenty three.
In addition to the readout in ovarian cancer in 2022, we also expect preliminary data from the investigator sponsored clinical trial of VB 111 in colorectal cancer in the first half of 2022.
And from the recurrent GBM trial in the second half of 2022.
We believe that we'd be 111 based on its dual mechanism of faction targeting tumor vasculature and immune recruitment has a potential to change the standard of care in multiple solid tumor indications.
As for our pipeline, we continue to advance our mono sites targeting program and expect to initiate a first in human study for our lead candidate VB six one in 2022 we believe that VB six to one and a new and differentiated approach in the landscape.
Of anti inflammatory agents by specifically targeting mono sites, which are crucial for the development of chronic immune inflammatory diseases.
Based on our promising preclinical data VB six of one and they have applicability for a range of high value immune inflammatory indications.
To prepare the company for their continued growth and the commercialization of VB 111, we recently strengthened our management and board and opened a U S. Office. In addition to the appointment of Sam back in roles as CFO. We also added Mike Rice and Alice.
Something gear to the board Mike has many years of capital markets and I, our experience with particular expertise in helping emerging biopharma companies.
Attack high quality investors Allison brings nearly three decades of leadership experience in biotech and pharma.
She was previously chief commercial officer at Bluebird Bio, where she built the commercial infrastructure in Europe and the U S. In advance of Bluebirds first gene and cell therapy product launches.
The B L is well capitalized with an expected cash runway into the fourth quarter of 2023 significantly beyond the PFS readout and potential BLA filing and we are excited to be building momentum as we head into 'twenty.
22, a year with a number of potential catalysts and multiple opportunities to create value.
At this point I would like to introduce some backend rose our chief financial officer to the audience.
<unk> has proven track record.
In corporate finance strategy operations and business development and I'm confident that his leadership and strong investor in banking relationships will help me be L. As we enter a new era of innovation and growth with that I will hand over to Sam to discuss the third quarter.
For 2021 financial results.
Please go ahead.
Thank you Gerard and good morning, everyone first of all I would like to see how thrilled I am to be working with Bbl's management team and board of directors to capitalize on our tremendous potential to bring novel therapies to people with cancer and immune inflammatory disorders, what drew me to V. B L. What's the company's cutting edge science and deep understanding of buyer.
Allergy, coupled with an with an experienced and proven team with the ability to develop highly differentiated therapeutics I'm, especially impressed by the corporate culture at V. B L and commitment of the entire team to help cancer patients in need and improve the standard of care I'm excited to be leading the build out of V. B L U S.
Operations as we head towards significant inflection points in 2022 and begin preparing for a potential commercial launch of VB 111. My appointment is consistent with the company's plan to raise awareness with investors and I look forward to meeting some of you in person in the coming months now onto the third quarter financial.
As of September 30th 2021 we had cash cash equivalents short term bank deposits and restricted bank deposits totaling $58 million. After the quarter ended we received an additional $9 $6 million in proceeds from warrant exercises, we expect that our cash and cash.
Equivalents and short term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements into the fourth quarter of 2023.
Revenues for the third quarter were 0.2 million as compared to 0.2 million for the comparable period in 2020.
R&D expenses net was $5 million for the third quarter as compared to $4 6 million in the same period of 2020.
For general and administrative expenses it was $1 6 million for the third quarter as compared to $1 3 million in the same period for 2020, and finally comprehensive loss for the third quarter was $6 5 million or <unk> <unk> per ordinary share compared to $5 8 million or <unk> 12 per basic share.
In the comparable period in 2020 with that I would like to return the call back to the operator for the question and answer portion of this morning's call. Thank you.
Thank you.
Now begin the question and answer session to join the question queue. You May Press Star then one on your telephone keypad, you'll hear a tone acknowledging your request.
If you are using a speakerphone. Please pick up your handset before pressing any keys to withdraw your question. Please press Star then two to join the question queue. Please press Star then one now.
Our first question comes from Kevin Dig Eater of Oppenheimer. Please go ahead.
Hey, Thanks for the update I used a few things from us a dror congratulations on the progress with overall enrollment.
I guess with a positive PFS.
Now do we think about you know the.
I'm on a clinical data as being the rate limiting step to our potential regulatory filings are there additional CMC investments. They were supposed to think about as being relevant to us as we think about potential timeline for our future BLA filing.
Okay.
So thank you Kevin that's a very good question and as you know we have our own facility commercial grade facility here in Israel, and I know that many times in gene and cell therapy is the issue of production is a major issue, but we were.
Preparing it ahead of time and as you know the CMC portion of the agency was already reviewing our a release a test laboratory and actually approved data and also all the benches that were used in the clinical trial and are used in the clinical trial. So.
I believe that we are actually doing quite well with the CMC and having a good result on the PFS, we will be able to actually be in a position to work on and submit the BLA, including the CMC.
Yeah.
Great and then with regard to you know I guess continued patient access to B B L 111 in ovarian cancer. Following completion of enrollment early next year is are there any plans for expanded.
They expanded access or a compassionate use program that they may be able to gather data there that could be helpful from a pre commercialization perspective.
Okay. So that's always a debate at the company should take because that's before you have a proof of concept that the drug is working although we had a very good phase two and also the interim analysis gives us a good handset we'd be 111 is actually working in a variant that you need to foolproof. That's on one hand on the other.
Other hand, you know that we never wanted to actually patient cross to VB 111, if they were on the control arm because the second primary endpoints that we're looking for is overall survival. So I believe that from the time that we are going to be fully recruited until such time that we will be able to actually.
And been able to talk about our top line results on PFS have not going to be such a long time and because of that the plan is that if we will dina and we'd say positive topline result, as we all hope and expect and then of course, we will start in <unk>.
Access program, although I have to remind everybody that because the study is going also for overall survival, we might be in a position that the PFS is actually.
And working very well and we are submitting a BLA, but this study will go on for the overall survival. So we will actually look at it in a very careful way, but we are making enough drug right now to be able to actually use it as an access program and compassionate patient because as you. All know this is a deadly disease and VB 111.
Might be a new way to actually change the standard of care for these patients and help bring hope to these patients.
Well congratulations on your progress and thank you for taking our questions.
Thank you very much COVID-19.
Our next question comes from Swamp cooler, Rob My Cup of H C. Wainwright. Please go ahead.
Thank you production unfolds and welcome aboard Sam.
So a couple of quick questions for me.
On the D S and review that is expected to take place in the first quarter.
I just said you would.
Data from almost all of them the patients in the trial so at that point.
You know what.
What sort of Ah indication are you going to get and are you gonna.
Let investors know.
Hum.
Yeah.
So RK I will take this.
Question.
And you know that when the TSMC is looking at the full dot that we are seeing only the blended total population data. So we don't know who is who but we do see the.
Results on each of the endpoint, but we are not talking about it we're very careful about it on the other hand, the TSMC exactly seeing the full data, including all the primary endpoint, where they can compare and get the data on each separate group, but it's of course.
It's not a clean data it wasn't adopt after all the query so while it's always going to be 100% they will be patient and wait a little bit until we clean the data and get top line results.
And my guess is that and they.
We will have the chance to tell us that we got the Green light and we should go for it and they of course will and might indicate to us. If we should expedite can get things cleaned up but they'll never stop a trial without looking at clean up that yes, and just to add to that I think just importantly.
From a disclosure perspective.
What you're likely to see.
As an investor or somebody looking at the story.
It would be something very similar to what we've disclosed in the past the DSM see how their meeting and then we give the very high level results and whatever their recommendation was with regards to moving forward.
Yeah.
Thank you and then I just stayed in next year.
Europe data on VB 111, so thinking about colorectal cancer and the G. P M.
I understand these are being run by <unk>.
And investigators and it's up to them as to what sort of data, but in general what should be the expectations from these from these groups.
The indications.
So as you know RK with tier when it is a NCI or investigator initiated trial, we depend on the NCI and all the doctors to run the trial. So it's more difficult to us to say exactly a date or things that we expect having saying that I have to say a couple of things first in the colorectal.
I'm, saying always on these calls and I'm, saying it whenever we meet with investors. We are looking to see if we can bring the immune system into their call them because the colon has a different immune system and that's a galasso trial in our point and we will know that hopefully in the first half okay of 'twenty two.
Can't say exactly when and regarding to the E. G. P. M. We as the trial is a double blind.
Stable control just as a reminder, any test three groups.
<unk> is actually getting VB 111 is a neo adjuvant before a second surgery, all patients or recurrent GBM all patient already failed surgery radiation and chemotherapy. So they have quite a great prognosis.
But theyre going to a second operation. The first day, a group will get the VB 111, as Neo adjuvant and later on after surgery as adjuvant.
The second group is getting placebo.
S. Neo adjuvant and then VB 111, and the third group is getting placebo Neo adjuvant and then to standard of care. So the idea is that in this trial is that we are getting the tissue of the tumor and a third of the patients will get VB 111 before surgery. So we will be able to know if even 111, indeed brain immune cell and changed.
Genetic of G. P M. As we think they should do and as we have evidence in animal models and the other indication you would be but never in the brain is definitely an opportunity to see that.
That's on the.
The trial is actually not a blinded because you know who is on standard of care and who is getting VB 111, and we're looking at six months PFS and overall survival. When we will have enough patient in that.
The investigator will think that that's a good time to summarize the data we will come to the market of course with this resource.
Usually and with some presentation I have two clinical conference.
Okay.
Okay.
How do you do.
Do you think that data if everything goes right is that enough to go to the FDA or do you need to do another trial to fly for them they'd be 111 in GBM.
Okay. The GBM trial was planned and I believe in a good way, it's not a big driver, but it's a randomized controlled trial and even when we got the results of the phase two trials that you know that was successful and the issues that the agency has to give us accelerating.
Station was because it wasn't a control time, so even in a small controlled trial. If you can show evidence of efficacy in this deadly disease, where nothing else working.
We will apply for accelerated approval for GBM, if we were to get it or not we will have to discuss it with the agency and of course and it all depends on the strengths of the data we will get to you.
So one last question for me Hum.
No oncology is one of the major focuses for VB, one maybe ill.
With the start of the mood music. So ones studies next year, how far would you take this molecule in development before seeking.
Seeking a partner for further development and commercialization.
Yes, so that's a great question and it's Sam here I think that really remains to be seen and we're designing our first in human clinical trial that we think is going to get us both safety as well as potential proof of concept in the ability to target monocytes, which as you know we're one of the three cell types that are implicated in inflammation, yet we don't really.
[laughter] therapeutics that can go ahead and address the monocytes specifically so I.
I think that that would probably be the right time. Once we have that proof of concept to start thinking about potentially bringing on a partner that will allow us to go after some much larger applications.
Whether thats rheumatoid arthritis, whether thats.
I'll sort of colitis, crohn's or other diseases like MFS that will.
We'll remain to be seen but certainly you know we would believe at that point that it would make sense for us to go at it with a good strong partner.
Thank you Sam Thanks, George talk to you soon.
Thank you RK.
Our next question comes from Jonathan Aschoff of Roth Capital Partners. Please go ahead.
Hi, Thanks, Good morning, guys and welcome aboard.
Can you be more specific about what you're currently doing to prepare for potentially successful oval at.
The PFS readout.
Such that you'd be in an optimal position to.
We filed for approval and commercialize VB 111 thing something that would.
Perhaps help us judge your PSS optimism.
Yes, so Jonathan that's a great question and we're really full steam ahead on all fronts right now.
I mentioned before we're doing the CMC preparatory work in order to enable us to be able to file a BLA as soon as possible. Once we have the PFS results and were investing in that right. Now. In addition to that we are in the process of <unk>.
Conducting a search for a chief commercial officer to do all of the pre commercialization work market access pricing reimbursement and everything that we really need to do to get ahead of things to.
To be ready for hopefully a positive PFS readout and then ultimately the launch of a drug. So we are doing everything that we can in order to accelerate and prepare ourselves for a positive result that will allow us to go ahead.
And file this off of a PFS.
Okay. Thank you very much.
Thanks, Jonathan.
Okay.
Once again, if you have a question. Please press Star then one.
Our next question comes from Jonathan Kreisman Vellore Research. Please go ahead.
Yeah.
Hi, everyone, Hi, Sam Congrats for assuming the role and wishing you all the best.
In this exciting phase of the build lifetime.
Also want to congratulate almost who belong your leadership and involvement in the this long journey to develop VB 111, and the rest of the programs.
So congrats to both of you.
Question for Dror.
I noticed some of the timelines for several programs of mood.
A little further.
Maybe if you could elaborate on the reasons for some of these delays.
For instance, a six to one entering the clinic in the second half of.
<unk> 22, and colorectal cancer study, which you initially expected to read out in the at the end of 'twenty one.
Okay.
I think it's quite obvious and.
What we are facing right now in the world with the pandemic there are issues with the E S.
A chain of E.
Comparison, there are issues with having a place to actually make the antibody because we know that's a lot of effort was actually shifted to where it's producing good vaccines for Covid 1919, and actually we are basically ready for <unk>.
Is submitting an R&D or starting the clinical trial, except for the concluding.
Concluding of production I'll say, a GMP manufacturing of six to one and thats supposed to be delayed because of the pandemic and I think that that's the only reason so nothing changing the program. It yesterday the change that we are having now in the landscape of egg production and <unk>.
A word and I'm glad to say that right now we are on track and that's why I mentioned that we are planning to have first in man already in 2022.
As far as other clinical trials as I was saying before the colorectal is actually NCI study and the GBM is in Paas.
An investigator initiated study and you're always depend on the investigators in this but I don't think it's a bad signal when a clinical trial, where you look for a clinical events in oncology is thinking of longer periods of time and we're it depends on having enough patient that we'll have enough biopsies.
In the colorectal trial before we can come with any rethought and of course, its not us its going to summarize these results and when we will get it from there.
NCI, we will definitely share between the market.
Yeah.
Yeah.
Okay, Great question for Sam So I'd appreciate to hear some of your thoughts as you were working through the learning curve.
Of gaining familiarity with the company and besides that if you could share any points or particular observations on what you intend to act upon and the short and medium term. Thanks.
Yeah, Yeah, no great question and I think you know my learning curve has been relatively short here because I've spent the last couple of years in genetic medicines.
So that my understanding of the technology or at least the basic elementary understanding is there now that I've been here for about six weeks certainly continuing to learn.
And now I'm already getting out there and starting to talk to investors about the story.
Looking both at the VB 111, as well as the 601 program and its application across multiple different inflammatory disorders.
I will say that working with the team here has been fantastic so far.
We've really been able to come together and.
Further the goals of the company to really accelerate drug development and bring these very important cutting edge novel therapeutics to patients as soon as possible.
And I think we continue to execute on that plan and we've really set up 2022 to be an incredibly exciting year for the company on both programs multiple data readouts on the clinical side and then entering the clinic in the second program I think we're really primed for a.
<unk> 2022 here.
Okay, great. Thanks, and good luck again.
Thank you.
This concludes the question and answer session I would like to turn the conference back over to the company for any closing remarks.
So thank you everybody for joining us on today's call and have a wonderful day. Thank you very much.
This concludes today's conference call you may disconnect. Your lines. Thank you for participating and have a pleasant day.
Yeah.
Okay.
Yeah.
Yeah.
Okay.
Yeah.
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