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BioLineRx Ltd. (BLRX)

Q2 2015 Earnings Call· Thu, Aug 20, 2015

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second Quarter 2015 Conference Call. All participants are 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 turn the call over to Josh Drumm of Tiberend Strategic Advisors to read the Safe Harbor statement. Josh, please go ahead.

Josh Drumm

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 that we filed in our 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 and 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 Financial and Operating Officer of BioLineRx. Phil, please go ahead.

Phil Serlin

Analyst

Thanks Josh and good morning everyone. In addition to providing a brief summary of recent activities, we will also highlight upcoming milestones for you on this call. On the call today, we have Dr. Kinneret Savitsky, CEO of BioLine and Dr. Arnon Aharon, VP of Medical Affairs and myself. Following our prepared remarks, we’ll be happy to take your questions. I will shortly review our achievements during the quarter and briefly summarize our numerous upcoming milestones for our therapeutic pipeline before I turn the call over to Dr. Savitsky who will dive into the details. First, I’d like to note that we remain on track to report topline data including response rates in Q4 2015 from our most advanced clinical trial for BL-8040, our oncology platform in the Phase 2 study for treating relapsed/refractory AML. Additionally, we look forward to meeting with the FDA in order to discuss our next steps in the clinical development program for BL-8040 as a novel stem cell mobilization treatment for transplantation including the design of a planned follow-up Phase 2 study. In addition, we have recently initiated a Phase 2b study for BL-8040 as a consolidation treatment for AML patients responding to standard induction treatment and are also in preparations to initiate two additional Phase 2 studies in two additional indications for BL-8040 in the upcoming month. Dr. Savitsky will shortly discuss all three of these new studies. In June, we presented the full safety and efficacy data from our successful Phase 1 study of BL-8040 as a novel stem cell mobilization treatment at the European Hematology Association Conference in Vienna, followed by a presentation of successful results from the Phase 1/2 study for novel celiac treatment BL-7010 at the International Celiac Disease Symposium in Prague. We were also pleased to share that BiolineRX’s…

Kinneret Savitsky

Analyst

Thank you, Phil, and good morning to everyone. As Phil mentioned, we expect some very exciting milestones for our BL-8040 oncology platform in the coming few months. First, we expect to report topline results from our ongoing Phase 2 clinical study of BL-8040 for treating relapsed/refractory AML in the fourth quarter. We have already discussed the highly encouraging results from the dose escalation phase of this study, which demonstrated rapid mobilization of cancer cells from the bone marrow as well as significant induction of cancer cell death. We are looking forward to reporting the topline results from this study including response rate as this represents the lead indication for BL-8040. As I will discuss, we are developing BL-8040 for a number of hematological indications where we believe it may demonstrate best-in-class potential. One dose indication is stem cell mobilization to support bone marrow transplantation. In March, we reported positive safety and efficacy results from the Phase 1 study for BL-8040, as a novel stem cell mobilization treatment and we afterwards presented the full study findings at the European Hematological Association Conference in June. Our study showed that BL-8040 was safe and well-tolerated at the dose of up to 1 mg/kg and induced dramatic mobilization of hematopoietic cells and progenitor cells as all doses tested. We show 9.5-fold increase in the number of stem cells in the peripheral blood following a single BL-8040 treatment. This robust mobilization supports the use of a single-injection of BL-8040 for stem cell collection. Further, we showed that the single-injection of BL-8040 enabled collection of higher than 11 million cells/kg following a standard apheresis session. While this yield [ph] exceeds the number of cells required to support a transplantation, the level of the relevant cells in peripheral blood circulation 24-hours after injection of BL-8040 also enabled…

Phil Serlin

Analyst

Thank you, Kinneret. Let me please turn your attention to the financials for the six months ended June 13, 2015. I will only go into detail on the most important financial statement items. Research and development expenses for the six months ended June 30, 2015 was $6.1 million, an increase of $0.6 million or 11% compared to $5.5 million for the six months ended June 30, 2014. The increase resulted primarily from increased spending on our BL-8040 project in the 2015 period, partially offset by decreased spending on BL-7010 and few earlier stage projects. Both G&A as well as sales and marketing expenses for the six month period in 2015 and 2014 were substantially similar. We continue to hold the line very tightly on our fixed cost. Our operating loss for the six month ended June 30, 2015 amounted to $8.5 million compared with an operating loss of $8.0 million for the six month period in 2014 reflecting an increase in R&D spending as mentioned. Our net loss for the six months ended June 30, 2015 amounted to $9.1 million compared with a net loss of $6.2 million for the six month period in 2014. The 2014 period reflects significant non-operating income related to the revaluation of warrants for accounting purposes on our balance sheet. Our operating cash burn for the six months ended June 30, 2015 amounted to $7.2 million compared to operating cash burn of $7.7 million for the six month period in 2014. The $0.5 million decrease is attributable to an increase in trade payables and accruals which should reverse themselves in the next month or two. As of June 30, 2015 we held almost $55 million in cash, cash equivalents and short-term bank deposits leaving us with a cash runway of over three years and allowing us to move forward with our aggressive clinical development strategy for BL-8040, continue to advance clinical developments in BL-7010 and efficiently pursue the multiple opportunities we hope to realize under our Novartis collaboration. That concludes the formal part of our presentation. Operator, we are now opening up the call to questions. Thank you.

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 Joe Pantginis of Roth Capital Partners. Please go ahead.

Joe Pantginis

Analyst

Hey guys, good morning, and thanks for taking the question. You have several inflection points coming up. So, I guess my questions would be focused on maybe a bit of a wish list on your end and expectations. So, first on 8040, with the response rate data coming up for AML, what your wish list is for next step, because obviously AML remains wide open with regard to lack of therapeutic options, and what a potential accelerated path might look like?

Kinneret Savitsky

Analyst

So, our plan with BL-8040 after the results, assuming that the results will be positive, will be discussion with the FDA and then will have more clarity about our next step. In parallel, we will have the consolidation study that will be up and running as we announced this week and two additional studies, which will be running before the end of this year. So, we plan to have more information in 2016 about the additional data from the aplastic anemia and MDS and also from the FLT3 mutated studies.

Joe Pantginis

Analyst

Sure. And then, staying with 8040 for stem cell mobilization, what would you define as your expectations from the FDA meeting? And you mentioned the potential initiation of a Phase 2 as the drug were to move forward in this indication, do you anticipate that you might have to do a head-to-head study against Mozobil?

Arnon Aharon

Analyst

Thanks for the question. We are actually going to the FDA to discuss the steps forward for approval of BL-8040 in both autologous and allogeneic transplantation in essence. Mozobil is only approved for autologous transplantation. So -- and it will aim at the end of the day for allogeneic and goes without saying that there is not going to be a need for comparison with Mozobil in terms of the autologous. We do not envision such but we will discuss this with the agency.

Joe Pantginis

Analyst

Okay. And then one quick last question. On 7010, would you be able to define what some of the outstanding questions are with regard to finalizing device status?

Kinneret Savitsky

Analyst

Yeah. Based on preliminary discussion that we had with a Notified Body, actually we received the conditional approval for the Phase 1/2 study that we already conducted. So, we do have some vision about what they are expecting to see. Some of the information we believe are supported by the results that we had. For example, we see no systemic exposure both in blood or in urine samples that we collected from the first human study -- first human study that we conducted. Probably, there will be more questions about the MOA. So, we started providing information and we will continue the discussions with them in the next few months.

Joe Pantginis

Analyst

Okay. Thanks guys. Very helpful.

Kinneret Savitsky

Analyst

Thank you.

Arnon Aharon

Analyst

Thank you.

Operator

Operator

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

Mike King

Analyst

Good afternoon guys. I think Joe Pantginis took care of bunch of my questions on 8040. I guess I would just ask if there is any additional color that you might be able to provide us with regard to the Novartis collaboration. Perhaps you can point us to certain areas of which -- of endeavor that you’re starting to concentrate on and I’d also ask if we should expect spending to begin to increase as the Novartis programs advance?

Kinneret Savitsky

Analyst

I can’t say much, but what I can say is that we had several meetings with them, face-to-face meetings both in Basel and in Tel Aviv. We presented a big chunk of projects that we screened in the last couple of months and this -- some of the projects were of interest, some are not, and we feel that we are continuing in the right direction and the feedback that we received so far is very positive.

Phil Serlin

Analyst

As far as the second part of your question, regarding an increase in spending, yes, we do anticipate an increase in spending of course, although, our three year timelines for cash or our more than three year timeline for cash already takes in to account that increase in spending.

Mike King

Analyst

Right. Okay. So is it fair to say, you’ve got at least the preliminary opportunity set to Kinneret’s point about the discussions with Novartis?

Phil Serlin

Analyst

Yeah. I mean I think that we’ve shown them a bunch of projects and you know the due diligence process takes times. We’re in that process right now.

Mike King

Analyst

Okay. Super. Thanks, guys.

Kinneret Savitsky

Analyst

Thank you, Mike.

Operator

Operator

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

Jason Kolbert

Analyst

Hi, guys. Can we talk a little bit about 8040 and how it would actually work in the allogeneic setting, what I want to understand is acting as a stem cell mobilizer with a graft versus host, what happens if there is residual and AID immunity in the host, don’t you worry that 8040 in the allogeneic setting could promote a failure versus a success, so I think it would be good if you could just opine on the science of that? Thanks.

Phil Serlin

Analyst

Okay. Thanks a lot. That’s a very good question and that is part of the work that we have been doing pre-clinically and was supported by the grafts that were collected in our Phase 1 study. As obviously, we are very much aware of the GVHD type risk with mobilizers and we are continuously monitoring our graft quality compared to the amount of immune cells -- p cells and other cells that are collected using G-CSF alone, using Mozobil when you go for the auto although within the auto, there is no risk of GVHD, but there were clinical studies done with Mozobil in the allogeneic setup as well. To our best understanding, we -- our graft component does not increase the risk of GVHD. We have closely monitored the amount of cells that are going to be introduced in to the recipient based on what will be collected from the donor and we feel that we are on solid ground here. Again, this is going to be part of our discussions with the FDA in regards to the duration of the follow-up and the early GVHD activity or the 100 days follow-up and then the chronic one, but to summarize that in a nutshell, we do not think that we pose additional risk to the recipient in terms of GVHD.

Jason Kolbert

Analyst

Okay. Very thorough. Thank you so much and the other questions help me really answer my questions. Thank you.

Phil Serlin

Analyst

Okay. Thanks, Jason.

Operator

Operator

[Operator Instructions] There are no further questions at this time. Before I ask Dr. Kinneret Savitsky to go ahead with her closing 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 1888-782-4291. In Israel, please call, 039-255-925. Internationally, please call 9723-925-5925. Dr. Savitsky, would you like to make your concluding statement?

Kinneret Savitsky

Analyst

Yes. I would like to thank all of you for joining us on today’s call. To summarize, we’ve continued to build positive momentum across our BL-8040 oncology platform and expect to maintain that momentum as we commence additional studies for this potentially best in class molecule. BL-7010 is set to advance a long and accelerated pathway for centrally providing celiac patients with new solutions for managing their disease. And finally, we continue to pursue new opportunities through our collaboration with Novartis. We look forward to announcing our first program when the right candidate is chosen. We remain well funded to achieve all of the significant milestones we have discussed today and look forward to entering this exciting period for BioLine and our shareholders. Thank you again for joining us and for your continued support. Good bye.

Operator

Operator

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