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BioLineRx Ltd. (BLRX)

Q4 2016 Earnings Call· Thu, Mar 23, 2017

$2.69

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Fourth Quarter 2016 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'd now 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, 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 to everybody. Thank you for joining us today on our year end 2016 earnings conference call. Earlier today, we issued two press releases. The first announced our acquisition of Agalimmune Ltd, and the second our year end 2016 results. You will find a copy of the press releases in the Investor Relations section of our Web site. They were also filed in 6-K this morning. Our announcement this morning of the Agalimmune acquisition is very exciting for us. As it is a first for BioLineRx with the assets and capabilities brought by the Company, playing to our strength through an expanded therapeutic pipeline and stronger focus on immuno-oncology. The transaction is a natural outcome of a very active year. With a reinvigorated organization centered on delivering its key corporate objectives in line with our vision, demonstrating meaningful milestones and achievements of our lead therapeutic platform BL-8040, including important collaborations with immuno-oncology leaders, Genentech, Merck, and MD Anderson and further validating our screening and drug development capabilities through an established immunology and fibrosis franchise with three programs announced under our Novartis collaboration. Our agenda this morning is to first provide you with the strategic rationale for our acquisition of Agalimmune, followed by a review of our accomplishments during the fourth quarter and full-year 2016. We will then discuss our financial results, enumerate our major target milestones for 2017 and 2018, and then open-up the call to your questions. Joining me on today's call are David Malek, BioLine's Chief Business Officer; Mali Zeevi, Chief Financial Officer; Abi Vainsteinm, Vice President Clinical and Medical Affairs; and Ella Sorani, Vice President Development. So let's get started. Many months in the making and after an extensive period of due diligence, we are very pleased to announce the acquisition of…

David Malek

Analyst

Thank you, Phil, and good morning everyone. We are very excited as BioLineRx having just added Agalimmune to our cancer immunotherapy programs, in addition to our existing collaboration with some of the global leaders in the immuno-oncology space. As Phil mentioned, I will begin by discussing our immuno-oncology collaborations with Merck, Genentech, and MD Anderson, that are based on our BL-8040 platform technology. BL-8040 in a best-in-class CXCR4 antagonist, which is being evaluated for its potential to improve the benefit of immunotherapy in cancer types that are currently resistant to such treatment. BL-8040 has been shown in several clinical and preclinical 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 antagonist, 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 or 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 in the fight against cancer. Our collaboration activity build on this. As we facilitate exploration of drug combinations that we believe could significantly increase the value and probabilities of success. And of note, our collaboration agreements relating to BL-8040 have no exclusivity which means that we fully retain our commercialization flexibility regarding the compound. Let me now provide you with an update on our immuno-oncology collaboration starting with our partnership with Merck. In January, we made our first foray into the immuno-oncology field as we announced the collaboration agreement with Merck to conduct a Phase 2a trial of BL-8040 in combination with Merck's anti-PD1 immunotherapy KEYTRUDA in the difficult to treat pancreatic…

Philip Serlin

Analyst

Thank you, David. We are focused to deliver on our corporate objectives. As we turn to 2017, we draw your attention to the following upcoming corporate milestones over the next 12 to 18 months. We expect partial results from the immuno-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. We also expect completion of our stem cell mobilization Phase 2 study for allogeneic transplantation by year end 2017. 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 a number of Phase 1b immuno-oncology studies for BL-8040 in combination with Genentech's Atezo in multiple solid tumor indications, as well as in AML during the second half of 2017 with partial results in the second half of 2018. 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 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. Before turning the call over to the financial discussion, I would like to spend a minute or two updating you on BL-7010, our product for the treatment of celiac disease and gluten sensitivity. Over the last two years, we put enormous efforts into examining alternative development and commercialization pathways for BL-7010 in addition to the celiac disease pathway, including as a food supplement…

Mali Zeevi

Analyst

Thank you, Phil. Please note that we invite you to review our annual 20-F, which contains our financial, 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 2016 were $11.2 million, a decrease of $0.3 million or 2.6%, compared to $11.5 million for 2015. The decrease results primarily from increase in spending on BL-7010, partially offset by increased spending on new projects. And on to cash, we ended 2016 with almost $36 million in cash, cash equivalents and short-term bank deposits. Our financial results provide us with a flexibility to pursue [ph] the programs into the first half 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

Thank you. Ladies and gentlemen, at this time we will begin the question-and-answer session. [Operator Instructions] The first question is from Richard [indiscernible]. Please go ahead.

Unidentified Analyst

Analyst

Hello. Thank you, Phil and other executives at BioLine. I had a question about the Agalimmune acquisition. I know that currently Novartis is set up to acquire to further license of drugs that are coming out of Israel. Will Novartis also be in a position to select candidates from the Agalimmune pipeline or that -- is that just exclusive to Israeli products? Thank you.

Philip Serlin

Analyst

Hi, thanks. Hi. Good morning and thanks for your question. On a contractual basis, the agreement and the collaboration with Novartis is limited to Israeli sourced assets. Novartis can as well as any other company can look at and speak to us about other assets, but this Agalimmune asset AGI-134 plus the other assets that are in their pipeline are not related to the framework agreement with Novartis.

Unidentified Analyst

Analyst

Thank you, Phil. About how many products are in the Agalimmune pipeline currently?

Philip Serlin

Analyst

David, can you answer that question?

David Malek

Analyst

Sure. Hi. Thanks for the question. I think one of the reason we’re excited about this acquisition is obviously AGI-134 as the leading asset in the -- clinical asset that we have high hopes for, but I think the other one as you mentioned is the fact that Agalimmune has developed several additional projects all revolving around the similar mechanism of action for targeting alpha-Gal. They’ve approximately four earlier stage projects basically all with immuno -- immunology, immunotherapy, immuno-oncology and all basically in the area or in the target of alpha-Gal, but with different moieties and different ways, people like to target that biological target which we find to be quite exciting and quite unique for this company.

Unidentified Analyst

Analyst

Yes, sounds great. And thank you, David and Phil for taking my question.

Philip Serlin

Analyst

Thanks very much.

Operator

Operator

[Operator Instructions] The next question is a follow-up from Richard [indiscernible]. Please go ahead. Richard are you with us?

Unidentified Analyst

Analyst

Oh no, I already did. I’m off now. Thank you. That’s all the question I have.

Operator

Operator

Okay, great. 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 1-888-782-4291. In Israel, please call 03-925-5940. Internationally, please call 972-3-925-5940. 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 are very excited about our prospects ahead and remain on target to delivering our objectives with a focus on building a pipeline of assets that leverages our scientific reach and expertise, specifically in the oncology, immunology space. We look forward to keeping you updated as we execute on our plans. Thank you very much.

Operator

Operator

Thank you. This concludes the BioLineRx fourth quarter 2016 conference call. Thank you for your participation. You may go ahead and disconnect.