BioLineRx Ltd. (BLRX) Q2 2017 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second Quarter 2017 Results Conference Call. 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.

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.

Thank you, Vivian, and good morning everyone. Thank you for joining us today on our second quarter earnings conference call. Earlier this morning, we issued our Q2 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. With our therapeutic pipeline expanded balance sheet bolstered an institutional ownership base strengthened in the first quarter. We now turn to highlight second quarter to date activities that we enforce our continued focus on delivering to our objectives. Before going into the advances of our clinical programs, primarily with BL-8040 in all three main pillars of our development strategy; stem cell mobilization, AML and immuno-oncology. I first want to remark that we are pleased with the further bolstering of our balance sheet from our largest shareholder BVF Partners. That provided an additional direct investment of $9.6 million into our company last month. This comes on the heels of BVF’s initial participation during our capital raise last March. To us BVF’s new capital infusion provides significant vote of confidence in our company, its clinical programs and initiatives. We aim to deploy these resources to further advance our therapeutic pipeline. All in all, with $62 million in pro forma cash at the end of the second quarter, we have resources to sufficiently fund and even accelerate our clinical programs for our two lead programs; BL-8040 and AGI-134 in addition to supporting other development activities that would to 2019. Turning to our agenda this morning, we will provide a review of the key developments achieved during the second quarter and year-to-date 2017. We will then discuss our financial results, enumerate our major target milestones for 2017 and 2018. Then open up the call to your questions. Joining me on today's call are David Malek, BioLine’s Chief Business Officer and Mali Zeevi, Chief Financial Officer. In addition, Abi Haras, Vice President Clinical and Medical Affairs and Ella Sorani, Vice President, Developments will both be available for the Q&A part. I will now review our BL-8040 activities and stem cell mobilization and AML, as well as, provide an update on our newest project AGI-134. Following that I will turn the call over David Malek to elaborate on the status of our clinical collaborations in immuno-oncology. In April, we announced plans to initiate a pivotal Phase 3 study for autologous bone-marrow transplantation in H2 2017. Shortly afterwards in May we announced that the successful conclusion of a meeting with the FDA where we discussed the clinical trial design for registration study. This randomized controlled study is expected to enroll approximately 200 patients and will investigate BL-8040 in combination with G-CSF. Compared to G-CSF with placebo for mobilizing stem cells from the bone marrow to the peripheral blood, followed by collection in the subsequent autologous transplantation in patients with multiple myeloma. We see this as a very significant development for BL-8040 at the BioLineRx as it marks a clear and relatively rapid pathway to bring our lead projects regulatory approval in the U.S. Our Phase 2 study for BL-8040 in stem cell mobilization for allogeneic bone marrow transplantation is ongoing. Following our release of positive interim data in March. As previously reported the partial data showed that the single injection of BL-8040 mobilized sufficient amounts of cells required for transplantation at a level of efficacy similar to that achieved by using 46 injections of G-CSF with the current standard of care. The study allows enrollment of recipient with either match siblings or haploidentical donors up to a total enrollment of 24 donor/recipient pairs. Top line results of this study are now expected in mid-2018. As a result of certain delays in study recruitment in connection with the addition of two sides to the study, and the regulatory filings associated with these additional sites. Moving on to AML, we continue to investigate BL-8040 as a consolidation treatment together with Cytarabine, the current standard of care for patients who have responded to standard induction treatment and are in complete remission. This Phase 2b trial is a double-blind placebo-controlled randomized multicenter study with upto 194 patients who will be enrolled in the trial. We continue to plan for an interim analysis on this study in the second half of 2018. Importantly, we also announced in May the regulatory submission for a new Phase 1b/2 clinical study to investigate BL-8040 in combination with Genentech’s Atezolizumab, as part of our multi-study collaboration with Genentech. We plan to initiate this study in the coming months as planned. Before turning it over to David to discuss our clinical collaboration with Genentech and Merck, I’d to provide an update on our second immuno-oncology drug program AGI-134. We were excited about extending our immuno-oncology capabilities by advancing AGI-134, which is less than a year away from the target first-in-man clinical study. We are currently actively discussing the types of indications, which would be investigated with key opinion leaders, as the drug has potential operability in multiple tumor types. As discussed last quarter, most immunotherapies work best in mutated tumors that are infiltrated with immune cells, termed hot tumors. Unfortunately, the overwhelming majority of humans tumors are cold tumors, therefore transforming a cold tumors into a hot tumor is a major objective in cancer treatment. With AGI-134 which one harnesses naturally pre-existing antibodies to elicit a tumor-specific immune response, the resulting activation and clonal expansion of T-cells to the patient's own neo-antigens has the potential to transform cold tumors to hot, thereby significantly expanding treatment potential. AGI-134, therefore has an extremely promising new therapeutic program to our immuno-oncology pipeline with a unique mechanism of action resulting not only in direct cytotoxicity of the injected tumor, but also cytotoxicity of distant existing metastases as well as the potential for long-term systemic anti-tumor immunity. And similar to our BL-8040 platform, we believe there are significant opportunities for combination treatments with other immunotherapies, especially, checkpoint inhibitors. I will now turn the call over to David.

Thank you Phil and good morning everyone. I will be discussing our immuno-oncology collaborations with Genentech, Merck, which are based on our BL-8040 platform technology. We are excited to be working with leading immune-oncology industry participants in combination trial for our lead program BL-8040. As you know, immune-oncology is one of the most promising approaches for the treatment of cancer. A lot of immunotherapies are receiving widespread attention. However, there is still substantial room for improvement, paving way for combination therapies that increase the efficacy of cancer immunotherapy. As previously reported, BL-8040, a best in class, CXCR4 antagonist is a powerful mobilizer of immune cells increases infiltration of immune cells into tumors and modifies the microenvironment in a pro-inflammatory manner. Therefore, when combined with PD-1 antagonist, such as Merck's KEYTRUDA or PDL-1 antagonists such as Genentech's Atezolizumab, BL-8040 has the potential to enable activated T cells to better reach tumor cell, increasing their impact on the tumor. Based on this principal, we have secured collaboration agreements with three leading immuno-oncology players; Genentech, Merck and MD Anderson Cancer Center. To date, we have two ongoing Phase 2 programs with Merck’s KEYTRUDA in pancreatic cancer. The first collaboration is between BioLineRx and Merck and the second is led by MD Anderson Cancer Center. We continue to expect partial results in our combination Phase 2 pancreatic study, named the COMBAT study in the second half of 2017. The study includes centers in the U.S., Israel and additional countries and is an open label, multi center, single arm trial, designed to evaluate the safety and tolerability of the combination of BL-8040 and KEYTRUDA. As well as multiple, pharmacodynamic parameters, in approximately 30 subjects with metastatic pancreatic adenocarcinoma. We have also announced the submission of three Phase 1b/2 combination trial with Genentech’s Atezolizumab and have recently reported the initiation of one of these trials in pancreatic cancer. The other indications include gastric cancer and non-small cell lung cancer. All trials remain targeted to initiate in the second half of 2017. In addition, our collaboration with Genentech also includes the Phase 1b or maintenance AML, which Phil had mentioned earlier. Our clinical collaboration with Genentech falls under the MORPHEUS Novel Cancer Immunotherapy Development program, earmarked to specifically assess efficacy and safety of drugs in combination treatments. We are very pleased that BL-8040 is being evaluated in multiple cancer types and the fact that BL-8040 was selected to take part in this significant clinical undertaking by Genentech, which provides some validation of our growing body of clinical evidence in support of BL-8040 as a best-in-class CXCR4 inhibitor. We look forward to providing update on this initiative. Let me now turn to call back to Phil.

Thank you, David. We continue to diligently execute on our clinical development plan, both internally and through our significant partnerships and we look forward to a number of important milestones in the next 12 months to 18 months as follows. We expect partial results from immune-oncology Phase 2a study for pancreatic cancer for BL-8040 in combination with Merck's KEYTRUDA by the second half of 2017 with top line results in the second half of 2018. Next, we expect to initiate a Phase 3 registration study in stem cell mobilization for autologous transplantation by the end of 2017. Further, we plan to initiate a total of four Phase 1b/2 studies for BL-8040 in combination with Genentech's Atezolizumab during the second half of 2017 with partial results in the second half of 2018. On July 10, we announced the initiation in the first of these studies of Phase 1b/2 study for pancreatic cancer under this collaboration. 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 H1 2018. We expect top line results of our stem cell mobilization in Phase 2 study for allogeneic transplantation by mid next year. Lastly, we continue to screen and review innovative projects both under our Novartis strategic collaboration as well as outside of the collaboration and we anticipate adding several value-add novel compounds to our pipeline over the next 12 months to 18 months. 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.

Thank you, Phil. Before I begin, let me invite you to review our quarterly filings, which contains our financials, operating and financial reviews and press release for additional information. I will only go over two significant items on this call; research and development expenses and cash including net proceeds from our recent direct investments from BVF in July. Research and development expenses for the six months ended June 30, 2017 were $7.7 million, an increase of $2.4 million or 45% compared to $5.3 million for the six months ended June 30, 2016. The increase resulted primarily from an increase in spending of our lead BL-8040 and AGI-134 projects. Turning to cash, the company held $52.6 million in cash, cash equivalents and short-term bank deposit as of June 30, 2017. In July, we received $9.5 million of net proceeds from the direct investments by BVF Partner bringing our pro forma cash balance as of June 30, 2017 including BVF’s investment to $62 million. We’re happy to note that our solid financials we think provide us with the resources necessary to fully execute on our operational plans over the next few years. With that, we have now concluded the formal part of our presentation. Operator, we are now opening up the call to question.

[Operator Instructions] First question is from Jason McCarthy of Maxim Group. Please go ahead.

Good morning all. A couple of questions, Phil, first the Phase 3 study, autologous BMT you said its going to start in this – later in 2017. Can you give us a sense of how many patients in centers were expecting – how long do you expect the trial to take to enroll? What’s the primary endpoint is? When we could see data, even interim data?

Abi, would you like to take that?

Yeah, [indiscernible]. Can you hear me?

Yes. I can.

Okay. Basically, we will have around 200 patients for these studies and more or less 16 to 20 sites across the U.S. The study is not planning to have an interim analysis and yes, we are aiming to open this trial during the last part of 2017.

Can we get any information on the endpoints?

Primary endpoint, yes, sorry I forgot. The primary endpoint would be that proportion of patients who are able mobilize are 6 million or more, so stem cells after two operations.

Okay. Great. And for the Phase 2b study in AML, I know you'll have an interim look in mid-2018, how many patients do you expect to have enrolled by then? Will that interim look give us any PFS data or relapse free survival?

Yeah, so, I mean we can't really tell you how many patients, it will be enough for us to give a robust interim analysis. It's more likely, not actually mid-2018, but I’d say second half of 2018, probably a little bit later in the year.

Relapse free survival.

Yeah, relapse free survival.

Which is the primary endpoint of this study we are aiming to present. But there is a lot of data that we will analyze over this time interim analysis.

Okay great, thank you for taking my questions.

Thanks, Jason. Appreciate it. Have a good day.

You too.

The question is from Joe Pantginis of Rodman & Renshaw. Please go ahead.

Hey, guys good morning. Thanks for taking the question. I wanted to talk about the COMBAT study a little bit with KEYTRUDA and pancreatic cancer. Obviously, we're just going to see interim data by the end of year. But as you look at the I guess, the building blocks of this study going from interim to top line next year. What do you consider to be your benchmarks for success? Obviously, you're going to be looking at multiple immune markers as well. You have some sort of internal response rates, you wanted to see initially? What are you going to do benchmark this study as a success?

For the interim – for the partial results we are aiming to show some data on monotherapy and the difference with the top line results is that, for the top line results we will want to show the data on the efficacy on the combination, this is mainly the difference on both – the thresholds can’t, it could be different, it’s nothing that we are not disclosing.

We have not disclosed the difference that we’re looking for.

I understood. No, I understand. Thanks. Then just switching to 8040, while keeping with 8040, but switching to AML. And this is a bit forward-looking, but obviously we just had a nice advance in the AML space with the approval of Vyxeos. Just curious your point of view on how 8040 might be able to play well in the same sandbox for potential combinations with Vyxeos going forward?

Hi, Joe, this is David. I think when we're looking at our activities currently in AML, as you can see we're focusing on consolidation and also on maintenance and these are two areas, where A; we see less competition directly and, B; we see a more - a stronger fit with the way BL-8040 works, which is – what we see is really a stronger BL-8040 and AML is due reduction of minimal residual disease or MRD. And we think with these two indications from sub-populations that you’d like within AML, consolidation at AML and maintenance at AML, those are the two population where we can see this feature or this unique activity of BL-8040, best come into play. And we think that again, the scientific rationale and the commercial landscape is quite attractive for BL-8040.

So, with anything else you little reach here, Vyxeos more in the frontline setting could potentially expand the population that's available for 8040 later on for consolidation and maintenance.

Absolutely. You are absolutely right, I think that’s the true statement, as we rely, both indications primarily on patients that had a successful induction therapy. So, if that translates into a higher number of patients, again both for maintenance and for consolidation that would definitely benefit the potential for BL-8040.

Got it. And then, if you don't mind one last question. More of a housekeeping question and I'll preface this by saying that I know this is a extremely minor impact right now. But was just curious as we look towards the future, BL-5010 is obviously approved when might we see even though they're minor, some potential royalties or payments from that?

Yeah. So, I mean, it will start to ramp up, probably in the next year or year and a half. I mean, I think that we don't expect to really have material revenues from this until I’ll have to say maybe two year to three years from now, it's ramping rather slowly. But we should continue to believe that we will eventually see royalty revenues around $3 million to $4 million range and the patent on this is quite long until sometime in the mid-2030. So, this should give us a nice, small-ish but nice annuity over the next a decade or a decade and a half. In addition, I’ll just remind you that we spent very little on this project, probably around $2 million in total. So, we think, we’ll eventually have a very nice return on investment.

Right. Appreciate the extra detail guys.

No problem. Have a great day.

The next question is from Mike King of JMP Securities. Please go ahead.

Hi guys. Thanks for taking the question. Just a couple of cleanup items. Phil, could you just talk about, will the Merck KEYTRUDA combination data be the only data we’ll see from 8040 for the remainder of 2017? Or do you think you may have a more robust set of data coming out for investors to take a look at on 8040 in combination with checkpoints?

Yeah, so I mean, that’s the primary data on checkpoint combinations and that’s coming out for the rest of the year. We have other significant milestones coming up in this sort of a Phase 3 study. A number of other studies in immunotherapy that are starting, but the main data – the readout that we will have is the immunotherapy data in the KEYTRUDA study.

Okay, fair enough. Maybe switching gears to 134. Can you talk about timing for initiation of development and what kind of studies you might be contemplating what kind of read outs you might provide to investors and whether there's any potential for combination studies of 134 and 8040?

Yeah, so, I’ll answer the first part of that and then I’ll turn it over to Abi to continue. We've been guiding all along and we're – there's no change that we expect to start the Phase 1 program in the first half of 2018. Like I said, we don't see any reason at all for that to change at this point. I’ll turn it over to Abi for as far as the –

The study will be a first-in-man study, the aim of the – as you know, for the first-in-man is mainly safety, but of course we’ll assess several biomarkers and we will check the safety and the efficacy as far as we can. And that’s the indication I cannot disclose as of yet. We will use also monotherapy for AGI and probably combinations or in fact we believe that the immunotherapy will shows us that as well.

Right. So, I guess, just to reiterate, so we do intend to investigate both AGI-134 as a monotherapy and also in combination. I think we've also disclosed the fact that we have very, very nice preclinical data in both the monotherapy setting and also in combination with the checkpoint inhibitor. We believe that going both ways would be the right – both pathways would be the right way to go with this effort.

Great. Thanks for taking the questions.

Okay. Thanks, Mike.

The next question is from Mark Breidenbach of Oppenheimer. Please go ahead.

Hey, guys, thanks for taking the questions. First of all, on the Phase 3 trial in stem cell mobilization patient. I was just wondering if there’s any chance of including a cohort of NHL patients or is this, I mean, strictly focused multiple myeloma?

Yeah, I mean, right now this study will be focused on multiple myeloma. We have a very significant objective to bring this to registration and we feel that is the quickest half way to registration. We’re certainly not ruling out the complementary studies or additional studies later on or in parallel. But in NHL, but on this Phase 3 we’ll be specifically devoted to multiple myeloma.

Okay. Understood. Since there a couple of trials, 8040 in combination with say, PD-1 blockade. I was wondering if you could give us a sense for if there is a real differentiator between the patients that are being enrolled in Genentech studies versus the COMBAT Study. As these two are turn differentiated from the experience Bristol-Myers had in its Phase 1/2 of its monoclonal antibody combined with nivo in pancreatic cancer.

Before I turn it over to Abi, so I’ll just take, so I mean, the Merck collaboration has been typically, related to pancreatic cancer. The Genentech collaboration has the number studies. One of which is pancreatic cancer. So, I assume you're talking specifically about pancreatic cancer right now.

Yeah, like what basically I'm looking for differences in as of two ongoing studies you're doing with your collaborators, maybe versus the experience Bristol-Myers has with the antibody domination.

Yes, go ahead.

First of all, one of the components of PD-1 and the others in PD-1 inhibitor may have the same results or different results or want to check throughout and we think everything is important to see, this indifference – with different combination as well as for different indication, with one of the product we have on the Atralin [ph] pancreatic cancer and the collaboration with Genentech we have three solid tumors to be treated. In result of your question about the other component and combination with the BMS compound CXCR4. The BMS compound is an antibody, the combination was two antibodies, the reason for what is it doesn’t [indiscernible] is what we drilled in program. I think there is no relation with our compound at all. We are talking about different molecule, different combination and the fact that they are both acting as a CXCR4 inhibitor doesn’t mean that the result will the same.

I also do recall, as I believe the regimen – the treatment --

The regimen, thanks for reminding me. First of all in our trials we are giving BL-8040, which is at a CXCR4 inhibitor, the monotherapy as a prime in [ph] treatment. Before the combination with checkpoint inhibitor, we didn’t see that it was done the same is for the BMS compound, that again, the combination of two antibodies may have other implications in terms of activity at the target area.

Mark, could I add something as well. I'd also like to mention actually we have two studies in KEYTRUDA that are running right now. I’m just not sure if you're aware, but I’ll just point it out. We have another study in pancreatic cancer that's running simultaneously to these two studies and that’s being run by MD Anderson under the framework of a collaboration that they have with Merck to investigate a number of GI type tumors in combination with KEYTRUDA and ours was the first therapy chosen under this collaboration and its right now also in a Phase 2 study for pancreatic cancer. The endpoints are a little bit different, the regimen is a little bit different. It has a lot more biomarker analysis in pharmacodynamic analysis. But we basically right now have about three shots on goal with pancreatic cancer.

All right. Thanks for that clarification. And one final quick one from me. The allogeneic HSCT trial with now you’re saying top line results in mid-2018. I’m just wondering if we're going to see anymore interim read-outs from this trial before that?

Yeah so, thank you for asking that question because this trial is investigator initiated. The trial is in collaboration with the Washington University in St. Louis. We have, I think one of the - certainly one of the advantages of this investigative initiated studies are that they are much, much less expensive. But I think on the other hand, one of the disadvantages, or the major disadvantages that you really don’t have much control over things. So, whereas in other types of settings where the sponsor, we could increase recruitment by opening new sites, at will, so to speak. It's much more difficult in investigator initiated setting. We're also limited as to what data we can put out because different partners have different policies regarding when and how data can be put out. So, we’re rather limited with what we can put on an interim basis or how to tell you. So having said that, I think that we’re probably not going to have much data on this until the top line result next year.

Understood. All right. Thank you for taking questions.

No problem.

[Operator Instructions] There are no further questions at this time. Before I ask Mr. Phil Serlin to go ahead with his closing statement. I would like 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?

Yes, thank you very much. I would like to thank all of you for joining us on today’s call and for your support. We are busy leveraging our scientific reach and expertise, partnership in oncology and immunology to continue to advance our therapeutic pipeline in the most efficient manner possible. Our team is driven and laser focused on executing to our plans and we look forward to providing you with timely updates on our progress. Have a good day and thank you very much.

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