Q1 2021 Vascular Biogenics Ltd Earnings Call
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Greetings welcome to V. B O Therapeutics first quarter, 2020 one 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 require operator assistance during the conference. Please press star zero on your telephone keypad. Please note. This conference is being recorded I would now like to turn the conference over to Lee Roth with Burns Mckellen. Thank you you may begin.
Thank you Gerry good morning, everyone and thank you for joining today's CDL Therapeutics first quarter 2021 financial results and corporate update conference call.
Leading the call. This morning will be professor drew on for Rob <unk>, Chief Executive Officer on.
Almost robb Chief Financial Officer.
Press release with the company's financial results was issued earlier. This morning and is available on the Investor Relations page of the company's website at D. D. L Rx Dot com.
Before I turn the call over to management I'd like to remind everyone that during this conference call forward looking statements made by management.
Intended to fall within the Safe Harbor provisions of the private Securities Litigation Reform Act of 1095.
<unk> 21 E of the Securities Exchange Act of 1934 as amended.
As set forth on our press release forward looking statements involve risks and uncertainties that may affect the companys 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.
Are available from the SEC or on our website.
Any forward looking statements made on today's conference call speak only as of today's day May 11th 2021, and the company does not intend to update any of these forward looking statements to reflect events or circumstances that occur after todays day.
As a reminder, the call is being recorded and will be available for audio rebroadcast on the company's website and we will have a Q&A session. Following today's prepared remarks with that said I'd now like to turn the call over to professor <unk>.
Go ahead Peter.
Thanks, Julie and good morning, everyone. Joining me on today's call is Amos Ron our Chief Financial Officer, who will discuss our first quarter financial results for 2021.
I'm pleased to say that it has been another productive quarter for Vivian with continuous progress on our lead programs they'd be 111, our novel gene therapy for solid tumors.
We continue to be encouraged by.
By the ongoing progress with our phase III pivotal trial in ovarian cancer, which if successful has the potential to reshape cancerous here of Boise and two established in your standard of care in challenging disease testing, where patients currently have limited channel.
On today's call I would like to focus on two significant points.
Which is the progress of the other trial the word potential BLA and the second is V. B L cash position as we prepare for their success and hopefully for commercialization of VB 111.
Starting with Alpha study.
Reminder, all value is an international placebo controlled double blind phase III registration, enabling study in recurrent platinum resistant ovarian cancer.
Date, we have had three successful debt from Siri views also study the most recent of which was in February following the review looking at 200 patients. The TSMC again gave us the green light to proceed as planned.
Enrollment in the value is going very well and he is now two third true as we continue to advance on study we look forward to the next day or some share with you in the third quarter of this year and they're achieving a full enrollment at the end of this year.
We remain encouraged by the high response rate and the total blinded data set as well as by the safety profile also study population and intend to provide an update on the other trial at the upcoming <unk> on.
France in June.
We are excited to advance they'd be 111 for the potential benefit of ovarian cancer patients and would like to thank all the patients and their families as well as the investigators health care professionals, who are taking part in this important international study.
As for the financial state of the company. We're pleased to announce in mid April debt, we closed a straightforward public offerings at market price to raise $28 3 million from existing shareholders as well as institutional funds from the U S.
Israel.
Together with an additional $12 $3 million that was injected into the company during the first quarter, mostly through the exercising of warrants that were issued in 2020, our cash position is now over $60 million.
This is expected to fund the company until year end 2023 through many milestones and most importantly, the readout from the other study and potential BLA submission for VB 111 in ovarian cancer.
We appreciate the continued support from our investors and look forward to rewarding their confidence in us as we continue to execute on our key strategic objectives.
Before I hand, the call over to our Chief Financial Officer, almost one I would like to say that we have continued the momentum we experienced in 2020 into 2021 and are encouraged by the significant advancements of VB 111, and our additional programs.
We look forward to sharing updates on our ongoing program specifically on the oven study during the upcoming <unk> conference and later through the rest of 2021.
With that.
I will hand off the call to Atmos, who will discuss our financial results for the first bolt on.
Thank you Dror.
Good morning to everyone.
As of March 31st 2021, we had cash cash equivalents short term bumps because it's in restricted bank deposits totaling 30 to $36 $6 million.
And working capital of $30 million $7.
As Joe mentioned.
In early Q2, we completed the public offering of common stock and pre funded warrants, which generated gross proceeds of approximately $28 $3 million.
For those unfamiliar with the term pre funded warrants are plus the securities book.
Hello investors that have restrictions on the ability to own company stock above it because you can make it the ownership threshold.
To invest additional capital in.
In practice the pre funded warrants.
The equivalent to ordinary should share without voting rights.
We expect that our cash and cash equivalents and short term bank deposits will.
Will it be sufficient to find operating expenses and capital expenditure requirements on till year end 2020 free.
Revenues for the first quarter were $185000.
As compared to $366000 for the comparable period in 2020.
Research and development expenses net.
It was $4.8 million for the quarter compared to $45 million in the same period in 2020.
General and administrative expense was about one $7 million for the quarter compared to $1 3 million daus in the same period in 2020.
And finally comprehensive loss for the first quarter was $6 $3 million or 12 cents per share compared to five $4 million or 50.
For sure last year.
With that I return the call back to the operator for the Q&A portion of this morning's call.
Thank you if you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if he would like to remove your question from the queue.
And from participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Our first question is from Kevin <unk> with Oppenheimer. Please proceed.
Hey, Thanks for taking my questions guys, maybe just two quick ones on on all of them then I would follow up on.
Dror can you just comment a bit about just the general scope of the updated ASKO in early June and then with regard to enrollment perfect day here.
<unk> continued success, there, but can you talk a little bit about.
No geographic enrollment, specifically certain geographies, where where you hope to be able to make.
Some incremental enrollment in the phase III to support.
Her regulatory and commercial.
Got on this call.
So Kevin.
Thank you for the questions as you can guess hey.
We always say in peak limited about what we can say about what.
What we are going to show.
High School.
Meeting the abstract say I'll say escalating they're going to be public in the air.
They may 19th.
There is a lot of you know sometimes the abstract itself is actually quite data and not giving a lot of information, but the trial in progress poster that we are going to present at the hospital going to add meaningful.
On a news about the study.
And they all should be June two day, Astro meeting, where we will be able to talk more about the trials that we're running right now at the oval trial.
As regard to geographic enrollment.
As you know today, a major part of our centers are in the U S and debt and most important market that we are.
Looking for but actually a recruitment is going very well both in the.
Europe in a U S and in Israel and all of that in spite of the COVID-19, and the COVID-19 is quite there was quite tough in Europe in the last day I had three or four months. Nevertheless, we are recruiting very well and actually we are over two third of the patients. So we're really.
On track to get to where we want to be by year end regarding.
The Japan on a market and I guess you are talking about it as well we have some centers opened right now, but we will announce when we have the first patient randomized and I have to remind everybody that this is a gene therapy based technology and our experience that it always.
Time to stop to stop using centers, but then when you stop it goes very well so we expect to see some patients in Japan as well in the near future.
Great and then my follow up question is on on colorectal I think we were looking for an update them.
Later this year any update on the progress of that study.
So first let me take care of it.
And the opportunity to say a couple of things about the other drivers. Besides the oval trial that we're running with a 111 the GBM trial is actually.
On a going well, we're opening centers recruiting patients and things going according to plan and when we will have some more.
More information we will of course.
Talking about it regarding the colorectal study, it's going very well if he's done with the National Cancer Institute as you know in this trial is a major thing. We are looking for is actually to see if indeed, where the viral product you can bring the immune system into the got in a similar way that we can bring it to other organs.
And in human being we have evidence that we are bringing a quite significantly in ovarian cancer in animal models, we had a lot of information about the other all guns, including lung liver and other and we know that we bring the immune system. There. The major question of course is the God because it got it.
Completely work differently.
And the immune system and as we all know there are bugs and viruses in our GAAP.
Normally in the question is of course, if viruses can bring the immune system into tumor in the gut we are expecting too.
Have these stats on later on this year a total defense.
Not really just on recruitment there is a decision and when we would get to enough.
A biopsy specimens that we can say meaningful things about this question then the people at the NCI going to actually look at all the slides and see if they can show.
On the immune system.
<unk> can be change in Tumours in day, a gut so I would actually expect to see results.
In the next three to six months.
Thank you for the update.
Yeah.
Thanks have a good reminder, it is star one on your telephone keypad, if he would like to ask a question.
Our next question is from Arthur he with H C. Wainwright. Please proceed.
Okay.
Hi, everyone and thanks for taking my question.
So for RK.
So.
Just a follow up on the COVID-19, sturdy I just wonder when could we expect the data update from this study I know you love about two third patient enrolled.
Could you give us some color on that part.
So let me. Thank you Arthur for asking a question, let me make a day completely clear about how we view the COVID-19 day story. So what I meant is that we the vap 111, our gene therapy. We are over two third are recruited.
Regardless of the story that it's difficult to recruit in the COVID-19.
Our program in COVID-19, with two one is actually completely different and I'll explain how and why the COVID-19 pandemic is actually a major problem globally, but.
Vaccination is working extremely well and in the pipeline there are anti viral therapies. So although.
CA.
Or maybe to a one hour drive just working on monocytes and can help in their pneumonia that you have in COVID-19, I believe that this type of drivers are actually not going to be very helpful. In the future, especially that we will have on P virus specific drugs and.
The vaccines that actually work.
Extremely well on more than expected and the immunity is day for quiet significant time and its good so far for <unk>.
Most of the mutated virus as it has been tested so we started this dry lineage weighted right now we don't have that many patients usually on almost none and we are not going to actually extend the outside of the country. Because we believe that this is an effort to distract us from the main programs that we have.
Yeah.
V B L.
Actually by the time that the study can be done we believe that the issues will be completely different.
That compound has a role in other viral infection, where there is chronic inflammatory disease. It's remained to be seen and we might have a collaboration on <unk>.
Debt with some major medical centers, but when that would be relevant we will actually talk about.
Thanks. Thank you. Thank you for the clarification.
And then my second question's on regarding the mass PD two program.
Could you just give us an update on the VEB six along the process.
So actually it. Thank you for asking Andy's question I Didnt mentioned that because I wanted to mentioned mainly the news that we have in the company right now, but the six on one program is going very well and according to plan and we are actually finishing the AI on DNA being studies, including toxicology.
<unk> when we will have the ripples, we will announce it but so far the drug seems to be very safe and we will discuss each day later on this year. We are now in the middle of free production I'll say.
Batch full day clinical trial, and we expect to see and.
First in man in the beginning call say 'twenty 'twenty two.
Thank you. Thank you for taking my question.
Yeah.
There are no further questions at this time I would like to turn the conference back over to professor her at for closing comments.
So thank you all for joining us this morning on our financial called Thank you and have a good day.
Thank you. This does conclude today's conference you may disconnect your lines at this time.
Thank you for your participation.
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