BioLineRx Ltd. (BLRX) Q2 2015 Earnings Report, Transcript and Summary

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.

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.

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 treatment of Type-1 diabetes won the Hebrew University's prestigious Kaye Innovation Award. The award was granted at Hebrew University immunologist Professor Ofer Mandelboim who studied the function of a protein receptor called NKp46 in the development of Type 1 diabetes. This groundbreaking research is a basis for BioLineRx’s BL-9020, a novel monoclonal antibody which targets the natural killer receptor NKp46 for the attenuation and treatment of Type 1 diabetes. We are proud to have the results of our clinical trial for BL-5010, a novel formulation for the non-surgical removal of skin lesions published in The British Journal of Dermatology. As previously disclosed, we out licensed this product in December 2014 to Omega Pharma, which was subsequently acquired by Perrigo. Omega Pharma plans to submit an application for CE Marking for BL-5010 in the third quarter of 2015. In addition, over the last few months, Omega Pharma has conducted a 30 patient open-label clinical study in Turkey to evaluate the advantages of BL-5010 in one of the intended OTC indications. Preliminary study results indicate that BL-5010 is safe and efficacious, we expect to receive full study results from Omega Pharma within the next few months and hope that first sales of BL-5010 in Europe will start in 2016. As you know last month, our partner Bellerophon reported topline results from its PRESERVATION 1 clinical trial for the bioabsorbable cardiac matrix (BCM) also known as BioLineRx’s BL-1040. This is an investigational implantable medical device being studied for the prevention of heart failure following an acute mild cardiac infarction commonly known as a heart attack. Unfortunately, this study did not show a statistically significant difference between patients treated with BCM versus placebo for either the primary or secondary end points. Bellerophon plans to report the full study data at the upcoming European Society of Cardiology’s Annual Meeting in September. While the future of the BL-1040 program remains highly uncertain at this moment, from our point of view, we believe it has a limited impact on our business as a whole based on the significant value of our development pipeline and our many upcoming milestones, which Kinneret will discuss further. It’s also important to remind our shareholders that this project was successfully out-licensed to Bellerophon in 2009 and that we have not done any work or incurred any costs in this project for more than five years. So far, we have netted positive cash flows on the out-licensing of BL-1040 in spite of the setback. We invested just over $10 million to develop BL-1040 prior to licensing, and under our agreement Bellerophon paid us a total of $17 million in upfront cash and milestones to-date. We believe that BioLine’s true value remains in our ability to advance our current pipeline to meaningful inflection points as well as our proven capabilities to identify in-license and advance new promising assets to fuel our continued growth, including the future programs we expect to initiate under our strategic collaboration with Novartis. To discuss our lead programs and the milestones we expect to achieve in the near-to-mid-term, I’ll now turn the call over to Dr. Savitsky. Following Dr. Savitsky’s remarks, I will provide a brief overview of our finances before opening the call to Q&A. Kinneret, the floor is yours.

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 an additional apheresis on Day 2, if needed. The cells collected from the healthy volunteers were also assessed for viability and quality in vitro and in vivo. Importantly, we showed that the collection of CD34+ cells was accompanied by mobilization and collection of colony-forming cells as well as T, B and NK cells. They also showed excellent engraftment in irradiated mice. This was followed by a rapid reconstitution of normal hematopoiesis. Collectively this data supports the use of BL-8040 as a single-agent, single-injection, one-day regimen for the collection of stem cells. This is a major improvement over current available procedures, which are longer and sometimes require a combination of several agents and multiple time-consuming apheresis sessions. Moreover, we see improvements in composition of the collected cells. This suggests the potential of a better quality graft, and may improve stem cell transplantation outcome. We are scheduled to meet with the FDA in October to discuss these results and determine the next steps in the clinical development of this program, which we expect to include initiation of the Phase 2 study as early as the first quarter of 2016. Phil also mentioned three additional Phase 2 studies for BL-8040. A few days ago, we announced the initiation of our Phase 2b study in consolidation AML. The Phase 2b study will examine BL-8040 as part of the second stage treatment, termed consolidation therapy, to improve the outcome for the AML patients who have achieved remission after standard first-line treatment regimen, called induction therapy. The consolidation therapy is aimed at eliminating the minimal residual disease left in the bone marrow that can lead to relapse. BL-8040 is anticipated to boost the efficacy of consolidation therapy due to its dual mechanism of action. On the one hand, this drug induces mobilization of leukemic cells from the bone marrow which enhance the effects of chemotherapy. On the other hand, it has an anti-leukemic pro-apoptotic properties that helps eliminate the AML cells directly. Based on positive results from our ongoing Phase 2 clinical trial for BL-8040, which showed substantial mobilization of AML cancer cells from the bone marrow to the peripheral blood as well as induction of apoptosis of AML cells, we believe BL-8040 will be a promising addition to consolidation therapy for AML patients. Finally, we are also in the final planning stages for Phase 2a studies in AML patients with FLT3-ITD mutation, and for MDS and aplastic anemia, both of which expect to commence by the end of this year. As you can see, we anticipate reaching several key inflection points and building significant value across our BL-8040 oncology platform. The multiple indications provide us with the ability to pursue several high potential unmet medical needs while reducing the overall development risk for this novel platform. In addition to our BL-8040 platform, we are continuing to maintain an ongoing dialog with the EU regulatory authorities through the notified body to confirm that our novel polymer BL-7010 for the treatment of celiac disease can be approved as their medical device in Europe. Following confirmation of device designation, we would expect to initiate what we hope will be a pivotal CE Mark registration study for BL-7010 in the fourth quarter of 2015 or beginning of 2016. Currently, we are completing additional non-clinical studies and formulation work which we believe will further support advancing and potential approval of BL-7010 in Europe. In addition to what I’ve highlighted on today’s calls, we continue to pursue various collaboration agreements to maximize the value of our current pipeline assets as well as talk to potential partners in order to monetize some of our non- core programs. In parallel to our internal pipeline development, we continue to screen potential assets to develop under our strategic partnership with Novartis. We are very pleased with the feedback that we have received from Novartis and will provide timely updates on therapeutic candidates selected by Novartis if and when these promising candidates emerge. With this, I will now turn the call over to Phil to give the financial overview.

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.

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.

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?

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.

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?

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.

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?

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.

Okay. Thanks guys. Very helpful.

Thank you.

Thank you.

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

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?

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.

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.

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?

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.

Okay. Super. Thanks, guys.

Thank you, Mike.

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

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.

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.

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

Okay. Thanks, Jason.

[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?

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.

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