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BioLineRx Ltd. (BLRX)

Q3 2016 Earnings Call· Tue, Nov 22, 2016

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Third Quarter 2016 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 now like to hand 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, believes, 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 on our third quarter earnings conference call. Earlier this morning we issued detailed results of our quarter. You will also find a copy of the press release in the investor relations section of our Web site. The third quarter marked several key milestones for the company as we continued to execute on our clinical program collaboration activities and business development initiatives. Our agenda this morning is to go over advancements made in our lead oncology platform, BL-8040, including our immunotherapy collaborations with Genentech and Merck and then focus on our long-standing relationship with Novartis. We will then shortly review our financial results for the quarter, enumerate our major target milestones for the remainder of the year and into 2017 and 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, BioLine's Chief Financial Officer. During the third quarter we made several key announcements on our BL-8040 program. This included continued advancements on the clinical programs in addition to new collaborations with major pharmaceuticals and industry participants in the high value fields of immunotherapy. As BL-8040 continues to be featured in key medical and scientific conferences, I will begin with a short review of the data we will present at the upcoming ASH meeting and then turn to discuss the various combination therapy trials for our lead oncology asset in the field of cancer immunotherapy. Following the presentation of successful final results of BL-8040s Phase 2a clinical trial in relapsed and refractory AML at the annual SOHO meeting two months ago, we are now poised for oral and poster presentation at the upcoming ASH conference in San Diego, California, taking place next month. At ASH, we…

David Malek

Analyst

Thank you, Phil and good morning everyone. We are very excited that BioLineRx is in cooperation with two of the three leaders in immuno-oncology. And at the heart of this is our BL-8040 platform technology, a best in class CXCR4 antagonist which is being evaluated for its potential to improve the benefit of immuno-therapy in cancer types that are currently resistant to such treatment. These include, major indications such as pancreatic cancer, gastric cancer and non-small cell lung cancer. There is a significant unmet medical need in these cancer types and the belief is that there may be a significant potential advantage by combining BL-8040 with immune checkpoint inhibitors. We believe that with BL-8040 we are well positioned to sustain a leadership position as currently there are very few clinical stage CXCR4 antagonists and none are currently investigated to the extent that BL-8040 is planned to be investigated. As noted in the past, BL-8040 has been shown in several clinical and pre-clinical studies to be a very robust mobilizer of immune cells and to be effective at inducing direct tumor cell death. Recent findings also suggest that CXCR4 antagonists such as BL-8040 may be effective in improving the infiltration of immune cells including T cells, into the tumor microenvironment. Therefore, when combined with PD1 antagonists such as Merck's KEYTRUDA for PDL1 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 cells and to fight against cancer. Net net, our collaboration has to been facilitate exploration of drug combinations that we believe could significantly increase the value and probabilities of success. This includes BL-8040 combinations with PD1 and PDL1 antagonists and the resulting impact of such combinations in both solid and liquid tumors.…

Philip Serlin

Analyst

Thank you, David. Now turning to milestones as the busy 2016 draws to a close and as 2017 approaches, we draw your attention to the following upcoming corporate milestones over the next six to 12 months. First of all, we expect our first milestone to be partial results from our stem-cell mobilization Phase 2 study which we expect to report by the first quarter of next year. We also expect to initiate a number of Phase 1b immuno-oncology studies for BL-8040 in combination with Genentech's Tecentriq, in multiple solid tumor indications as well as in AML during 2017. In addition, we expect to announce the partial results in our Phase 2a immuno-oncology study in pancreatic cancer for BL-8040 in combination with Merck's KEYTRUDA by the second half of 2017. 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 eagerly anticipate the in-licensing of several value-add novel compounds during 2017. Before turning to our discussion of our financial results for the third quarter, I would like to reaffirm that our global access to cutting edge assets and capabilities is solidly in place. We ended the third quarter with around $39 million in cash and we believe we have the resources to leverage these opportunities as well as support and development in growth efforts. I would now like to turn the call over to Mali Zeevi, our CFO, who will give a brief overview of our key financial statements items.

Mali Zeevi

Analyst

Thank you, Phil. Please note that we invite you to review our quarterly 6-K which contains our financials, operating and financial review and press release for additional information. I will only go over through significant items on this call, research and development expenses and cash. Research and development expenses for the nine months ended September 30, 2016 were $8.2 million, a decrease of 5.1%, compared to $8.7 million in 2015. The decrease resulted primarily from lower expenditures for BL-7010 during the 2016 period and conclusion of one of the clinical trials for BL-8040 in 2015, partially offset by increased spending on a new project. As far as cash is concerned, we ended the September quarter with almost $39 million in cash, cash equivalents and short-term bank deposits. This provides us a with a cash run rate to carry out our current operational plans through at least the beginning of 2019. With that, we have now concluded the formal part of our presentation. Operator, we are now opening up the call to questions.

Operator

Operator

[Operator Instructions] The first question is from Jason Kolbert of Maxim Group. Jason, please go ahead.

Jason McCarthy

Analyst

Jason McCarthy for Jason Kolbert. Just a question on the Tecentriq combination study that’s coming up. In pancreatic, lung or other tumors or cancer types like AML, have you seen increased expression of PDL1. Are you using that as a diagnostic criteria for enrolling patients and do you have any data that suggest that BL-8040 as a monotherapy is driving increased expression of PDL1 on different types of cancer. Thanks.

Philip Serlin

Analyst

Thanks, Jason. It's good to speak to you. I just wanted to introduce in addition to David Malek, here we also have the following people on the call. We have Dr. Merril Gersten, our CSO. We have [ Dr. Abby Weinstein] our head of medical affairs, and [indiscernible] who is leading our BL-8040 project. I will ask Abby.

Unidentified Company Representative

Analyst

About the design of the study and the assessment that we do before the recruitment of the patient, I am sorry but I cannot disclose. And mainly this trial in solid tumors are being done by Genentech. We are the provider for BL-8040 and we cannot disclose what are the details of this trial and that is not yet finalized neither.

Jason McCarthy

Analyst

Okay. Have you seen, in your AML studies, increased -- BL-8040 as a monotherapy, is it driving increased PDL1 expression. Have you observed that?

Unidentified Company Representative

Analyst

We didn’t test PDL1 expression in AML.

Jason McCarthy

Analyst

Okay. Great. And as far as -- when do you expect that we can get an update or may be a timeline on the live fibrosis projects with the Novartis collaboration. It seems to me NASH is becoming a hotter and hotter topic [indiscernible] lately. I am curious and excited to see that biologic moving into this area.

Philip Serlin

Analyst

You know, I have to tell you that these are preclinical stage projects. I have to say they are probably somewhere between two and three years before the clinic and so you know, I mean, I think that’s the most general idea that I can give you at this time.

Operator

Operator

The next question is from Joe Pantginis of ROTH Capital Partners. Please go ahead.

Joe Pantginis

Analyst

Could you provide a little more detail or maybe remind us a little about the protocols surrounding the 8040 KEYTRUDA studies but specifically the protocols around pre and post biopsies. When are you going to be testing these biopsies and what exactly are you going to be looking for, presumably through immunohistochemistry. Thanks.

Philip Serlin

Analyst

Abby, can you answer that?

Unidentified Company Representative

Analyst

I am really sorry but I think that they are details on the clinical protocol that I cannot disclose, I am sure, with you, but we are aiming to test the biopsies across the study. Cannot say when exactly but we have to have data that can support the mechanism of function of BL-8040 in this area.

Operator

Operator

[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 to remind participants that a replay of this call is scheduled to begin two hours after the conference. In the U.S., please call 1-866-276-1485. In Israel, please call 03-925-5944. Internationally, please call 972-3-925-5944. 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. We remain committed to making steady progress on our existing clinical program as well as the introduction of promising new programs and the signing of new collaborations. We remain well-funded to achieve all of the significant milestones we have mentioned and look forward to keeping you updated as we execute on our plans. Thank you again for joining us and for your continued support and we would like to wish you happy Thanksgiving to all of our U.S. investors.

Operator

Operator

Thank you. This concludes the BioLineRx third quarter 2015 results conference call. Thank you for participation. You may go ahead and disconnect.