Earnings Labs

BioLineRx Ltd. (BLRX)

Q1 2017 Earnings Call· Thu, May 25, 2017

$2.69

+20.41%

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First Quarter [Technical Difficulty]. All participants are at present in listen-only mode. Following the management's formal presentation, instructions will be given for the question-and-answer session. [Operator Instructions] I would like to turn the call over to Ms. Vivian Cervantes of PCG Advisory to read the Safe Harbor statement. Vivian, please go ahead.

Vivian Cervantes

Analyst

Thank you, operator. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. All statements in this conference call other than historical facts are indeed forward-looking statements. The words anticipate, believe, estimate, expect, intend, guidance, confidence, target, project, and other similar expressions are used typically to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance and may involve and are subject to certain risks and uncertainties and other factors that may affect BioLineRx's business, financial condition and other operating results. These include, but are not limited to, the risk factors and other qualifications contained in BioLineRx's annual report on Form 20-F, quarterly reports filed in a 6-K and other reports filed by BioLineRx with the SEC to which your attention is directed. Actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements. BioLineRx expressly disclaims any intent or obligation to update these forward-looking statements. At this time, it is now my pleasure to turn the call over to Mr. Phil Serlin, Chief Executive Officer of BioLineRx.

Philip Serlin

Analyst

Thank you, Vivian, and good morning everyone. Thank you for joining us today on our first quarter March 31st 2017 earnings conference call. Earlier this morning, we issued our Q1 earnings results. You will find a copy of this press release in the Investor Relations section of our website. Results were filed in the 6-K this morning. I'd like to begin by highlighting that our activities this year have not only fueled significant excitement at BioLineRx, but also reinforced our position in the high value field of immuno-oncology. The announced our first acquisition of Agalimmune Ltd in March via which we expanded our therapeutic pipeline to include a second I/O compound AGI-134. And given the opportunity, we secured additional funding in April, bolstering our already strong cash position. With net proceeds of over $26 million, on top of over $30 million in cash at the end of March 31st, our pro forma Q1 cash position stands at almost $57 million, sufficient a fund and even accelerate our clinical programs for BL-8040 and AGI-134 in addition to supporting other development activities through late 2019. Importantly, these recent activities that strengthened our institutional ownership base as we continue to deliver on our mission to advance early oncology and immunology compound into valuable therapies for patients with high unmet needs. This includes focused development of our stem cell mobilization program with a Phase 3 pivotal study poised for initiation in the second half of 2017 and which we plan to potentially commercialize ourselves. Mozobil, a comparable drug used in this therapy reported 2016 revenue of around $150 million. Net-net we are strengthening our immuno-oncology platform, aggressively advancing our lead assets with valuable partnerships, and a clear regulatory pathway and obtaining increased participation from fundamental investors to fund our development and growth programs. We…

David Malek

Analyst

Thank you, Phil, and good morning everyone. I will begin by discussing our immuno-oncology collaborations with Genentech, Merck, and MD Anderson that are based on our BL-8040 platform technology. As we have previously discussed, our collaboration activities bailed on BL-8040 as a best-in-class CXCR4 antagonist as it improves the infiltration of immune cells into the tumor microenvironment. Therefore, when combined with PD-1 antagonists such as Merck's KEYTRUDA or PDL-1 antagonists such as Genentech's Atezolizumab, which enabled the activation of anti-tumor immune T cells. BL-8040 has the potential to enable activated T cells to better reach tumor cell and to fight against cancer, increasing the value and probability of success. Of note, our collaboration agreements relating to BL-8040 have no exclusivity or partnering commitments, which means that we fully retain our commercialization flexibility regarding the compound. In September last year, we announced our immunotherapy collaboration with Genentech, a robust program with several Phase 1b studies investigating BL-8040 in combination with Atezolizumab, Genentech's anti-PDL-1 cancer-immunotherapy in multiple cancer indications, all of which are expected to initiate in the second half of 2017. Genentech also have the option to add up to three more indications under this collaboration for other solid and liquid tumors. We are very pleased to highlight that we are now poised to initiate the first Phase Ib clinical trial under this collaboration in the second half of 2017, following completion of the regulatory submission for the BATTLE study in maintenance AML. The studies are planned as open-label multi-center single-arm trials designed to evaluate the safety and efficacy of the combination of BL-8040 and Atezolizumab. Upon completion of the studies, both parties will have the option to expand the collaboration to include a pivotal registrational study. Turning to our immuno-therapy collaboration with Merck, we're pleased to report continuing advancement in…

Philip Serlin

Analyst

We're very focused to deliver on our corporate objectives. Over the next 12 to 18 months, our target milestones are as follows; we expect partial results from our immuno-oncology Phase 2a study for pancreatic cancer for BL-8040 in combination with Merck's KEYTRUDA by the second half of 2017 of this year with topline results in the second half of next year. Next, we expect to initiate a Phase 3 registration study in stem cell mobilization for autologous transplantation in the second half of this year. Further, we plan to initiate four Phase 1b immuno-oncology studies for BL-8040 in combination with Genentech's Atezolizumab in the second half of 2017 with partial results in the second half of 2018. We also expect completion of our stem cell mobilization Phase 2 study for allogeneic transplantation by year end. And we plan to initiate a first-in-man clinical study with AGI-134, our new innovative immuno-oncology asset obtained as part of the Agalimmune acquisition during the first half of 2018. Lastly, we continue to screen and review innovative projects under our Novartis strategic collaboration as well as outside of the collaboration both for our own pipeline as well as for our joint venture in China and we anticipate continued in-licensing of value add novel compounds. We will provide you with timely updates as we execute on our plans. I would now like to turn the call over to Mali Zeevi, our CFO, who will give a brief overview of our key financial statement items. Mali go ahead.

Mali Zeevi

Analyst

Thank you, Phil. Before I begin, let me invite you to review our quarterly filings, which contains our operating and financial reviews and press release for additional information. I will only go over three significant items on this call; research and development expenses and cash including net proceeds from our financing in April. Research and development expenses for the three months ended March 31st, 2017 were $3.6 million, an increase of $1.1 million or 41% compared to $2.5 million for the three months ended March 31st, 2016. The increase resulted primarily from an increase in spending on BL-8040 as well as an increase in spending on new projects. Turning to cash, the company held $30.4 million in cash, cash equivalents, and short-term bank deposit as of March 31st, 2017. In April 2017, we completed an underwritten public offering of our American Depository Shares for net proceeds of $26.2 million. Our financial resources provide us with a flexibility to pursue our programs into late 2019. With that, we have now concluded the formal part of our presentation. Operator, we are now opening up the call to question.

Operator

Operator

Ladies and gentlemen, at this time, we'll begin the question-and-answer session. [Operator Instructions] The first question from [Indiscernible] of JMP Securities. Please go ahead.

Unidentified Analyst

Analyst

Thanks for taking the question guys. As you mentioned Phil, you are engaged in the discussions with the FDA regarding the registration program for 8040 in setting of autologous transplant. I was wondering if you could perhaps share the details of your interactions with the agencies specifically as they relate to the trial design for your upcoming Phase 3, are you trying patient enrolment, potential end point, et cetera. Let’s start with that and I have a quick follow-up. Thank you.

Philip Serlin

Analyst

Yes, hi. I don’t think actually we are going to be able to give much color on that right now. We will be obviously filing a protocol for that and I think we will be able to give more color on that a little bit later in the year, but I don’t think we are really going to be able to give much color like as I said. Abi, is there anything.

Abi Vainstein-Haras

Analyst

No, I don’t think so. We are working on that and we are -- we discussed with them the design and that currently we cannot share this information, not now.

Unidentified Analyst

Analyst

Okay.

Philip Serlin

Analyst

Sorry. As soon we are able to we will obviously give full disclosure of the design etcetera, etcetera.

Unidentified Analyst

Analyst

Okay. Appreciate that. And then in autologous transplant, I mean how to get into the details obviously, but the discussions with the FDA did we touch on that at all, may be preliminary registration program discussed there would it be separate from the autologous transplant? Thanks.

Philip Serlin

Analyst

Yes, it is -- go ahead Abi.

Abi Vainstein-Haras

Analyst

No, we focused this meeting only autologous stem cell mobilization. We had a meeting the past about allogeneic, but this meeting was only focused on autologous program.

Unidentified Analyst

Analyst

Okay. Thanks guys.

Philip Serlin

Analyst

Okay. Thank you.

Operator

Operator

Your next question from Joe Pantginis of Rodman & Renshaw. Please go ahead.

Joe Pantginis

Analyst

Hey, guys. Good morning. Thanks for taking the question. Couple if you don’t mind. First, when you are looking at potential for AGI-134, you already have these collaboration for I/O with Merck and Genentech's, so what is the potential as you get to the clinic to have this product just act as a bolt-on to these collaborations?

Philip Serlin

Analyst

David, go ahead.

David Malek

Analyst

Thanks. Hi Joe, how are you? Yes, I think, it’s a good question. We already shared some data that was generated pre-clinically about the potential synergies in AGI-134 and checkpoint inhibitors versus PD1 inhibitor and we definitely think there is a true potential for that moving forward obviously, but some level of monotherapy that we wanted to check first in humans, but that’s definitely a direction that we are looking into and we'll start developing. Obviously, we just got the projects in our hands recently, but this direction is definitely we want to go forward.

Joe Pantginis

Analyst

Got it. And then with regard to -- I am sorry.

David Malek

Analyst

No, go ahead.

Joe Pantginis

Analyst

With regard to the 8040 AML consolidation study, Phil you mentioned that there is a potential I think for interim data in 2018, or I should just say in interim look does that include potential data or just looking at typically DSMB look at the study?

Philip Serlin

Analyst

Yes. We are not completely closed on that yet, but I have to say, it’s more likely to be the second, DSMB look at the study some type of utility or whatever now that would be more likely the scenario.

Joe Pantginis

Analyst

Got it. And my last question, if you don’t mind is more of microscopic business strategy. Over the last one year or six months to a year, you've obviously brought your focus onto immuno-oncology you have the collaboration with Merck and Genentech's and you also all of the ongoing screenings with Novartis. So with that said you have a lot of balls in the air right now. You have good cash balance to bring your programs forward. So what is your appetite at this point to look for additional collaborations or expansions or what have you?

Philip Serlin

Analyst

Yes well first of all, you should I think that we've mentioned in the past the Novartis collaboration comes with the certain level of funding. And so potentially a program that we would bring in and when it would get to the clinic we would have quite a bit, the majority of the clinical development would be funded. So that provides us with the ability to bring in assets that we would otherwise probably not be able to bring in at this point. So I think that we are -- we have a lot on our plate right now I think, you're correct. We are continuing to bring in assets. We will be very picky as far as what we're bringing in. I think that you probably will see assets that are more advanced than let's say in the past. We had brought in we are probably going to be looking less at early stage preclinical assets and more in the later stage preclinical and IND-ready or early clinical stage. So I think that's sort of our focus. Again we have the funding mechanism with Novartis which is of course is very crucial to being able to carry out those plans.

Joe Pantginis

Analyst

Got it. Thanks a lot guys.

Operator

Operator

The next question from Jason Kolbert of Maxim Group. Please go ahead.

Jason Kolbert

Analyst

Hi Phil. Thanks for taking the questions. Can you guys talk a little bit more about AGI-134 and the mechanism of action, is it differentiated from using maybe an I/O 12 approach and since in the preclinical work that's been published there seems to be synergy with checkpoints. So once you move into the clinic, are you considering going rate to a checkpoint combination or are you going to try to do this as a model therapy first and then see what that looks like and take it from there?

Philip Serlin

Analyst

Go ahead. Abi, would you like to take that.

Abi Vainstein-Haras

Analyst

No, I wanted to refer to the last part of your question about the combinations. Yes, of course in oncology, we are always trying to do combination that we are looking also at activity of AGI-134 as a single agent. When will be the right time to combine that as we are discussing this right now, but we believe that this compound can be effective as the monotherapy as well and that again will be -- it's too early now to say what would be the timing for the combination and when we will do that?

Philip Serlin

Analyst

And I think I just want to add to what Abi said or maybe emphasize we think there is a lot of rationale behind AGI-134 as a model of therapy. Also as we've mentioned in combination, but we would really like to maximize the potential from a clinical development perspective of showing bringing data robust data on a model therapy basis. So we're going to do whatever we can to move forward on that basis as well as on a combination basis.

Jason Kolbert

Analyst

Okay. Thanks and just a quick question on the 2b study and I know you are going to take a look potentially in 2018, but even if you wait for the data in 2019 a full dataset with 194 so patients and given the need at this line of therapy is there the possibility that this could be used for registration or is that something that you're thinking about?

Abi Vainstein-Haras

Analyst

This is something that we will need to discuss to the point that we have the data is very difficult to discuss this kind of or to make this kind of arrangement with FDA without having the data. But we had in the past the meeting with MHRA and we discussed the design of this study on what will be the next step and they were very optimistic and they were…

Philip Serlin

Analyst

They were open

Abi Vainstein-Haras

Analyst

…open and willing to collaborate with us in order to get in the earliest manner to the market, but again with FDA we didn't discuss that and we need to discuss at point we have the result.

Philip Serlin

Analyst

And Jason, I think that it's clear that a lot will be depend on the robustness of the data and obviously, if we have very robust data that will put us in a lot better position to have this discussion and find some shortcuts with regulatory authorities.

Jason Kolbert

Analyst

Okay, great. Thank you for taking the questions.

Philip Serlin

Analyst

Thank you.

Operator

Operator

[Operator Instructions] There are no further questions at this time. Before I ask Mr. Phil Serlin to go ahead with concluding statements, I would like to remind participants that a replay of this call is scheduled to begin two hours after the conference. In the U.S., please call 1-877-456-0009. In Israel, please call 03-925-5946. Internationally, please call 972-3-925-5946. Mr. Serlin, would you like to make your concluding statement?

Philip Serlin

Analyst

Yes, thank you. I would like to thank all of you for joining us on today's call and for your support. We're focused on building a pipeline of assets that leverages our scientific reach and expertise, particularly in oncology and immunology. Our team is driven and excited about our prospects. We look forward to providing you with timely updates as we execute on our plans. Have a nice day and thank you joining us.

Operator

Operator

Thank you. This concludes the BioLineRx first quarter 2017 conference call. Thank you for your participation. You may go ahead and disconnect.