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spk00: everyone, and thank you for joining the VBL Therapeutics Third Quarter 2021 Financial Results and Corporate Update Call. Joining me on the call is Professor Bo Harad, Chief Executive Officer, and Sam Backenroth, Chief Financial Officer. A press release of the company's financial results was issued earlier this morning and is available on the Investor Relations page of VBL's website at ir.vblrx.com. 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 Security Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934 as amended. 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 filing with the SEC, which includes, among other things, our annual report on Form 20-F. These filings are available from the SEC or on our website. Any forward-looking statements made on today's conference call speak only as of today's date, Monday, November 15th, 2021, 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. 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 Loharat. Loharat, please go ahead.
spk01: Thank you, Erez, and good morning, everyone. Joining me on today's call is Sam Beckinross, our new chief financial officer, who will discuss the third quarter 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 VBL. We expect to have data from multiple VB111 clinical trials in high-value indications, including the progression-free survival co-primary endpoint from the phase III oval study in ovarian cancer. We also anticipate beginning first in human studies, evaluating VB601, our monocytes targeting antibody, for the treatment of chronic immune inflammatory diseases. Our Oval Clinical Trial, a registration-enabling phase three study of VB111 in ovarian cancer, has now enrolled over 85% of the targeted study patient population. and we expect to complete enrollment in the first quarter of 2022. Also, in the first quarter of next year, we expect to have another DSMC review, which will include a data set of almost 100%, if not a 100%, of the total study population. The next milestone in the overall trial we are looking forward to is a readout of the progression-free survival co-primary endpoint in the second half of 2022. This is particularly important as successfully meeting the PFS endpoint has the potential to enable us to submit a BLA one year ahead of plan compared to our original projections, which were based on the readout of the overall survival primary endpoint, which remain anticipated in 2023. In addition to the readout in ovarian cancer, in 2022 we also expect preliminary data from the investigator-sponsored clinical trial of VB111 in colorectal cancer in the first half of 2022 and from the recurrent GBM trial in the second half of 2022. We believe that VB111, based on its dual mechanism of action 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 monocytes targeting program and expect to initiate a first in human study for our lead candidate VB601 in 2022. We believe that VB601 has a new and differentiated approach in the landscape of anti-inflammatory agents by specifically targeting monocytes, which are crucial for the development of chronic immune inflammatory diseases. Based on our promising preclinical data, VB601 may have applicability for a range of high-value immune inflammatory indications. To prepare the company for the continued growth and the commercialization of VB111, We recently strengthened our management and board and opened a U.S. office. In addition to the appointment of Sam Beckenrose as CFO, we also added Mike Rice and Alison Finger to the board. Mike has many years of capital markets and IR experience with particular expertise in helping emerging biopharma companies attack high-quality investors. Alison 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 US in advance of Bluebird's first gene and cell therapy product launches. VBL is well capitalized. with the expected cash runway into the fourth quarter of 2023, significantly beyond the BFS readout and potential BLA filing. And we are excited to be building momentum as we head into 2022, a year with a number of potential catalysts and multiple opportunities to create value. At this point, I would like to introduce Sam Beckenrose, our Chief Financial Officer to the audience. Sam has proven track record in corporate, finance, strategy, operations, and business development. And I'm confident that his leadership and strong investor and banking relationships will help VBL as we enter a new era of innovation and growth. With that, I will hand over to Sam to discuss the third quarter 2021 financial results. Sam, please go ahead.
spk04: Thank you, Gerard, and good morning, everyone. First of all, I would like to say how thrilled I am to be working with VBL'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 VBL was the company's cutting-edge science and deep understanding of biology, coupled with an experienced and driven team with the ability to develop highly differentiated therapeutics. I am especially impressed by the corporate culture at VBL 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 VBL's U.S. operations as we head towards significant inflection points in 2022 and begin preparing for a potential commercial launch of VB111. 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 on to the third quarter financial results. As of September 30, 2021, we had cash, cash equivalents, short-term bank deposits, and restricted bank deposits totaling $50.8 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 $0.09 per ordinary share compared to $5.8 million or $0.12 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.
spk03: Thank you. We will now begin the question and answer session. To join the question queue, you may press star, then 1 on your telephone keypad. You will 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 2. To join the question queue, please press star, then 1 now. Our first question comes from Kevin DeGieter of Oppenheimer. Please go ahead.
spk05: Hey, thanks for the update. I guess a few things from us, George. Congratulations on the progress with OLL enrollment. I guess with a positive PFS readout, should we think about the timeline of clinical data as being the rate-limiting step to a potential regulatory file, or are there additional CMC investments that we should also think about as being relevant to we think about potential timeline for future BLA filing?
spk01: 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, the issue of production is a major issue, but we were actually preparing it ahead of time. And as you know, the CMC portion of the agency was already reviewing our release test laboratory and actually approved it, and also all the batches 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 a BLA, including the CMC.
spk05: Great. And then with regard to, you know, I guess continued patient access to VBA111 ovarian cancer following completion of enrollment early next year, are there any plans for you know, expanded access or compassionate use program that may be able to gather, you know, data that could be helpful from a pre-commercialization perspective.
spk01: Okay. So that's always a debate that the company should take because that's before you have a proof of concept that a drug is working, although we had a very good phase two and also the interim analysis give us a good hint that VB111 is actually working in a variant that you need the full proof. That's on one hand. On the other hand, you know that we never want to actually patient cross to a VB111 if they were on the control arm because the second primary endpoint that we are looking for is overall survival. So I believe that from the time that we are going to be fully recruited until the time that we will be able actually been able to talk about the top line results on PFS are not going to be such a long time. And because of that, the plan is that if we will be with a positive top line result as we all hope and expected, then of course we will start an access program. Although I have to remind everybody that because this study is going also for overall survival, we might be in a position that the PFS is actually working very well and we are submitting a BLA, but the 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 compassion at the patient because, as you all know, this is a deadly disease, and VB111 might be a new way to actually change the standard of care for this patient and bring a hope to this patient.
spk05: Well, congratulations on your progress, and thank you for taking our questions.
spk01: Thank you very much, Kevin.
spk03: Our next question comes from Swampakula Ramakant of HC Wainwright. Please go ahead.
spk07: Thank you. Good afternoon, folks, and welcome aboard, Sam. So a couple of quick questions from me. On the DSM review that is expected to take place in the first quarter, as I said, you would potentially have data from almost all of the patients in the trial. So at that point, you know, what sort of indication are you going to get and are you going to let investors know from that review?
spk01: So, RK, I'll take this question. And you know that when the DSMC is looking at the full data, we are seeing only the a 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 DSMC is actually 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, not a clean data It wasn't the data after all the queries. So although it's going to be 100%, they will be patient and wait a little bit until we clean the data and get top-line results. So my guess is that they will have the chance to tell us that we got a green light and we should go forward. And they, of course, might indicate to us if we should expedite and get things cleaned up but they'll never stop a trial without looking at clean up data.
spk04: Yeah, and just to add to that, I think just importantly from a disclosure perspective, what you'd likely to see as an investor or somebody looking at the story would be something very similar to what we've disclosed in the past. The DSMC has their meeting, and then we give the very high-level results and whatever their recommendation was with regard to moving forward.
spk07: Thank you. And then, as you stated, next year is the year of data on VB111. So thinking about colorectal cancer and GBM, I understand these are being run by independent investigators, and it's up to them as to what sort of data. But in general, what should be the expectations from these groups on both the indications?
spk01: So as you know, RK, when it is a NCI or investigator-initiated trial, we depend on the NCI and on the doctors who run the trial. So it's more difficult to us to say exact date or date thing that we expect. Having saying that, I have to say a couple of things. First, in the colorectal, as I'm saying always on this course, and I'm saying it whenever we meet with investors, we are looking to see if we can bring the immune system into the colon because the colon has a different immune system. And that's the goal of the trial in our point. And we will know that hopefully in the first half of 22, but I can't say exactly when. In regarding to the GBM, We, the trial is double-blind, placebo-controlled, just as a reminder, and it has three groups. The group A is actually getting VB111 as a neoadjuvant before a second surgery. All patients are recurring GBM. All patients already felt surgery, radiation, and chemotherapy, so they have quite a great prognosis, but they're going to a second operation. The first group will get VB111 as neoadjuvant and later on after surgery as adjuvant. The second group is getting placebo as neoadjuvant and then VB111. And the third group is getting placebo as neoadjuvant and then the standard of care. So the idea in this trial is that we are getting the tissue of the tumor and a third of the patient will get VB111 before surgery so we will be able to know if VB111 indeed brings immune cell, and change the genetic of GBM as we think it should do, and as we have evidence in animal models and other indication in human beings, but never in the brain, and that will be an opportunity to see that. From that on, the trial is actually not blinded because you know who is on standard of care and who is getting VB111, and we're looking at six months PFS and overall survival. When we will have enough patient and the a investigator will think that that's a good time to summarize the data, we will come to the market, of course, with this result, usually with some presentation at the clinical conference.
spk07: Okay. So 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 file for BB-111 in GBM. Okay.
spk01: The GBM trial was planned, I believe, in a good way. It's not a big trial, but it's a randomized controlled trial. And even when we got the results of the Phase II trial that you know that was successful, the issue that the agency had to give us accelerated registration was because it wasn't a controlled trial. So even in a small controlled trial, if you can show evidence of efficacy in this deadly disease when nothing else working, we will apply for accelerated approval for GBM. If we will get it or not, we will have to discuss it with the agency. And of course, it all depends on the strengths of the data that we will get here.
spk07: So one last question from me. I know oncology is one of the major focuses for VBL. with the start of the BB601 study next year, how far would you take this molecule in development before seeking a partner for further development and commercialization?
spk04: Yeah, so that's a great question, and it's Sam here. You know, I think that really remains to be seen, and we're designing a 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 are one of the three cell types that are implicated in inflammation, yet we don't really have therapeutics that can go ahead and address the monocytes specifically. So 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 that's rheumatoid arthritis, whether that's ulcerative colitis, Crohn's, or other diseases like MS, that will 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.
spk07: Thank you, Sam. Thanks, Rohr. Talk to you soon.
spk06: Thank you, Aki.
spk03: Our next question comes from Jonathan Astroff of Roth Capital Partners. Please go ahead.
spk06: Thanks. Good morning, guys, and welcome aboard, Sam. Can you be more specific about what you're currently doing to prepare for a potentially successful oval at the PFS readout, you know, such that you'd be in an optimal position to, you know, swiftly file for approval and commercialize VB111? You know, saying something that would perhaps help us judge your PFS optimism?
spk04: Yeah, so Jonathan, that's a great question, and we're really full steam ahead on all fronts right now. You know, as Dora 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 we're investing in that right now. In addition to that, we are in the process of 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 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.
spk06: Okay. Thank you very much, Sam. Thanks, Jonathan.
spk03: Once again, if you have a question, please press star, then one. Our next question comes from Jonathan Kreisman of Velour Research. Please go ahead.
spk02: Hi, everyone. Hi, Sam. Congrats for assuming the role and wishing you all the best in this exciting phase of VBL's lifetime. Also want to congratulate Amos for the long year leadership and involvement in this long journey to develop VBL11 and the rest of the programs. So congrats to both of you. Question for Dwar. I noticed some of the timelines for several programs have moved a little further. Maybe if you could elaborate on the reasons for some of these delays. For instance, 601 entry in the clinic in the second half. of 22 and colorectal cancer study which you initially expected to read out in the end of 21.
spk01: I think it's quite obvious in what we are facing right now in the world with the pandemic. There are issues with a chain of commerce and there are issues with having a place to actually make the antibody because we know that a lot of effort was actually shifted toward producing vaccines for the COVID-19. And actually, we are basically ready for submitting an IMD or starting the clinical trial except for the concluding of the production of the GMP manufacturing of 601 And that was a bit delayed because of the pandemic. And I think that that's the only reason. So nothing changed in the program. It's just the change that we are having now in the landscape of production in the world. And I'm glad to say that right now we are on track. And that's why I could mention that we are planning to have first in man already in 2022. As for other clinical trials, as I was saying before, the colorectal is actually a NCI study, and the GBM is an investigator-initiated study, and you 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 clinical events in oncology is taking a longer period of time. and where it depends on having enough patient that will have enough biopsies in the colorectal trial before we can come with any results. And of course, it's not us that's going to summarize this result, and when we will get it from the NCI, we will definitely share it with the market.
spk02: 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 a company? And besides that, if you could share any points or particular observations on which you intend to act upon in the short and medium term. Thanks.
spk04: Yeah, great question. And I think my learning curve has been relatively short here because I've spent the last couple of years in genetic medicines. So 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 and looking both at the VB111 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 great 2022 here.
spk02: Okay, great. Thanks, and good luck again. Thank you.
spk03: This concludes the question and answer session. I would like to turn the conference back over to the company for any closing remarks.
spk01: So thank you, everybody, for joining us on today's call, and have a wonderful day. Thank you very much.
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