Vascular Biogenics Ltd (VBLT) 2015 Q4 法說會逐字稿

Good day, everyone, and welcome to the VBL Therapeutics fiscal year 2015 earnings call. Today's event is being recorded. I will turn the call over to Paul Arndt, managing director at LifeSci Advisors.

Thank you. Good morning, and thank you for joining us. With me today are Dror Harats, CEO, and Amos Ron, Chief Financial Officer. A press release with the Company's 2015 financial earnings became available at 8 a.m. Eastern time today and can be found on the investor section of the Company's website at www.ir.vdlrx.com.

I am required to remind you that the information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that VBL's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by VBL's forward-looking statements due to risks and uncertainties associated with VBL's business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and VBL's SEC filings.

The content of this conference call contains time-sensitive information that is accurate only as of the date of today's broadcast, Tuesday, March 29, 2015. VBL undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call. I would now like to turn the call over to Dror Harats.

Thanks, Paul. 2015 was an important year of progress for VBL, and we are looking forward to continue his momentum in 2016. In the past year, we have shifted our focus to concentrate on oncology, where we believe we have a game-changing technology. Our goal is to become a leading biopharmaceutical Company focused on discovering, and commercialization, innovative, first-in-class therapies for oncology indications. We have a broad pipeline of assets with programs from preclinical stage all the way to a phase 3 registration study.

In 2015, we met multiple important milestones in our drug development. I am happy to report since we completed our phase 2 program with our lead candidate, VB-111 in recurrent glioblastoma, or recurrent GBM, where we report a significant increase in overall survival. During 2015, we also reported positive results in our phase 2 ovarian and thyroid cancer studies. We initiated our pivotal GLOBE trial in recurrent GBM, which strengths our intellectual property and added to our balance sheet with successful follow-on offerings.

Beginning with our most advanced program, VB-111, the most significant accomplishment in 2015 was completion of a successful phase 2 clinical trial in recurrent GBM, with data being presented at the ESMO conference in Europe and at the Society of Neuro-Oncology annual meeting. This trial met its primary endpoint, showing statistically significant overall survival benefit in patients treated with continuous dosing of VB-111 with Avastin, compared to patients who received limited dosing of VB-111. The data from this study showed that VB-111 almost doubled the historical median overall survival for recurrent GBM.

Now we are naturally cautious about looking at historical controls, and we wanted to have more confidence that VB-111 is in fact different from Avastin. Therefore, we compared the VB-111 data to four different studies which evaluates the efficacy of Avastin in recurrent GBM. And as we presented at SNO, the analysis showed that the overall survival rate for patients treated with VB-111 in combination with Avastin was 57% at 12 months, compared with an overall 12-month survival of 28% in the pool data from the four published Avastin studies, which was highly statistical significant.

Since the ECC and the SNO conferences, in which the phase 2 data were presented, we also ask an independent scientific group to perform a meta-analysis on the literature of overall survival as reported for Avastin and comparing to our VB-111 data. This meta-analysis, whose results we will present in the next quarter, has been submitted to the FDA along with a full phase 2 data for VB-111. We are in correspondence with the agency about an access program which VBL would like to implement in order to enable compassionate use of VB-111 to patients who are not eligible for enrollment into our GLOBE study. This, of course, will be done in a manner that will not jeopardize our pivotal study.

We are now actively recruiting patients for the phase 3 GLOBE study of VB-111 in recurrent GBM. This study, which started in August 2015, is comparing VB-111 in combination with Avastin to Avastin alone, and is proceeding under a special protocol assessment, or SPA, granted by the FDA, and the primary endpoint is overall survival. We are enrolling patients who have failed chemotherapy, radiation and surgery. I will talk more about the GLOBE study in a few minutes.

In ovarian cancer, we report positive data from our phase 2a trial at the ASCO meeting in June 2015. This study looked at VB-111 in combination with paclitaxel and was the first trial to investigate VB-111 in combination with chemotherapy drug. The interim results show that for those patients who received a full dose of post paclitaxel and VB-111, there was a 60% response rate as though many of the patients were already Avastin failer. This represented (inaudible) of response compared to what has been shown with Avastin historically.

In thyroid cancer, we reported results from our phase 2 trial in October announcing that the primary endpoint of six months progression-free survival had been met. This trial had enrolled 29 patients with metastatic radioiodine-resistant differentiated thyroid cancer, whose disease had progressed within the six months prior to enrollment. Most of the patients' cancer had previously not responded to various therapeutic interventions, including radiation, thyroid, kinase inhibitors and cytotoxic agents.

On the intellectual property front, we hit an important milestone in December, when we were granted the US composition-of-matter patent that provides protection for VB-111 in the US until October 2033. This will give us significant time to sell this drug exclusively, and that is before any extension. We have a strong portfolio with worldwide coverage protection of our asset.

Finally, we secure an additional $15 million cash in the follow-on financing that we completed, which we expect will allow us to operate through the first half of 2018 post our phase 3 readout on the GLOBE pivotal trial.

We are looking forward now to a very active 2016 for VBL and to building on the progress we have made. The phase 3 GLOBE study in recurrent GBM, as I said, is actively recruiting patients and will remain according to plan. According to the GLOBE phase 3 study protocol, an interim analysis will take place when 91 mortality events will occur in the trial. We want to be careful about providing timing estimates, but we expect that the interim analysis, which depends both on enrollment as well as on VB-111 activity, will take place in the first half of 2017. Full data will be available when 151 events will occur in the trial. Based on our interaction with FDA, we believe that the current trial will support a BLA application in 2018.

I will remind you that VBL has received fast-track designation for recurrent GBM in the US and orphan drug status in both the US and in Europe. With ovarian cancer, since reporting the phase 2 data, we have been following the patient for tumor response in survival, and the data are now much more mature. We were also able to obtain biopsies from tumors of ovarian cancer patients in order to study the effect of VB-111 histologically, and we believe that these samples strengths our understanding of the immune oncology response in the mechanism of VB-111. We expect to release the updated results from this study in the second quarter of 2016.

We are summarizing all the data and intend to submit it to the FDA for an end-of-phase-2 meeting very soon. Pending the feedback from the agency, we are considering to launch a randomized controlled trial for VB-111 in ovarian cancer subject to securing the required funding. We will provide more color on the development program of VB-111 to platinum-resistant ovarian cancer in the next quarter.

In thyroid cancer, we will continue to observe the enrolled patient in the phase 2 trial and expect to provide full report by the end of 2016, including survival data.

Now I would like for Amos Ron, our Chief Financial Officer, to give you more details about the financing and our current financial state of affairs. Amos.

Thank you, Dror. Research and development expenses for the year ended December 31, 2015 were $11.2 million, compared to $11 million for 2015. The bulk of our R&D expenses for the VB-111 subcontractors and consultants in 2015 as a phase 3 pivotal trial of VB-111 in rGBM commenced in August 2015.

General and administrative expenses for the year ended December 31, 2015 were $3.7 million, compared to $3.8 million for the prior year.

We recorded a net loss of $14.9 million, or $0.73 per share, for the year ended December 31, 2015, compared to net loss of $17.4 million, or $3.09 per share, in the same period of 2014.

We ended the year with cash, cash equivalents and short-term bank deposits of $37.1 million, compared to [$36.8 million] at the year-end 2014. We currently expect that our cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for approximately 30 months, or until at least mid-2018. Additionally, we currently expect the funds to be sufficient to complete our ongoing phase 3 clinical trial of VB-111 in neutron GBM, to complete our phase 2 clinical trial of VB-111 in thyroid cancer and to complete our phase 1-2 clinical trial for VB-111 in ovarian cancer.

Now I would like to turn the call over to the operator for questions and answers.

(Operator Instructions) Joe Pantginis, Roth Capital Partners.

Two questions actually, if you don't mind. First, with regard to GLOBE, are you able to receive any anecdotal visibility from the study regarding the protocol and what you have in the protocol with regard to trying to keep patients on despite potential progressions?

Joe, thank you for asking the question. We actually, as you know, completely blind it -- the Company. So we don't get any information about that. And we will know only when we will have the data in our hands. We didn't hear from the people who run the trial, the CRO or from the PI of the trial that there are any issues so far.

No, that's very fair. Thank you. And then my second question would be what would you define as the open questions or issues that need to be addressed regarding the access program that you are seeking?

So of course, one of the major issues is that we don't want to have any option for patients who were on the control arm on Avastin to have an access to VB-111 later on because that's going to jeopardize the clinical trial. So the idea is first to stop this program basically when we are almost completely or completely recruiting for the GLOBE trial, which should happen relatively soon by the time that we will be ready for the success program. And the other thing is that of course we're going to (inaudible) inclusion criteria that is going to make sure that no patient that were on the GLOBE trial will be able to get to the success program.

On the other hand, it will enable patients that didn't have the chance to go on this trial. Maybe because there weren't a lift closing up to some centers that are involving the trial. Or for example, if they had a third recurrent, so they are not eligible for the trial, they will be allowed to get the drug as a compassionate. Because you all know that right now there is a major need for patients with the recurrent GBM. And we get a lot of pressure from patients and doctors to get the treatment with VB-111.

Thank you very much.

(Operator Instructions) Mike King, JMP Securities.

I apologize if you had mentioned this; I was jumping between calls this morning. Dror, I just heard you mention in response to Joe's question that GLOBE should be enrolled soon. Can you say, roughly speaking, when you expect GLOBE to complete enrollment? And also if you would give us a rough approximation of when you think you might hit that 151 patients landmark in the trial.

Mike, good morning to you. And we are trying to be very careful, but the GLOBE trial is recruiting according to plan. And if everything goes according to plan, we should finish recruiting by the first quarter of next year. And things are going according to plan. We are very happy with our recruitment; I must say so.

And then the 91 events, it all depends -- if we keep recruiting according to plan, then it will all depend on the activity of VB-111. The later it will take place, the better we are. We believe that the whole (technical difficulty) 51 data will be ready toward the end of 2017. If VB-111 will perform even better than it did in the phase 2, then it might be a little bit later.

Okay. And then just the significance of the halfway mark? Is that something that you are still considering as an option for analysis?

Definitely. It's not in our hands. It's in the hands of an independent TSMC and the FDA because we are the only part that is completely blinded. But, yes, they have the charter to look at it.

Great. Thank you very much.

At this time, I will turn the conference back to Mr. Harats for any additional remarks.

Thank you all for participating in our -- today's VBL earnings call. And we hope to give you more news later on this year. Thank you very much.

That concludes today's conference. Thank you for your participation. You may now disconnect.