BioLineRx Ltd. (BLRX) Q1 2015 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First 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 anticipates, believes, estimates, expects, 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 BioLine’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 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 Financial and Operating Officer of BioLineRx. Phil, please go ahead.

Thanks Josh. And good morning everybody. I’ll start off by saying that we expect this to be a relatively short call compared to previous quarters. While we’ve continued to make many important advancements along our core pipeline of novel therapies, in particular for our expanding BL-8040 platform in hematology, there has been relatively limited news since our last update, which was less than two months ago. As we strongly focused our efforts on executing on our aggressive clinical plans, I am happy to say that we remain on track for reporting on several significant clinical milestones over the coming months. In addition to providing a brief summary of our recent accomplishments, we will highlight those upcoming milestones to you on this call. As always, on the call today, we have Dr. Kinneret Savitsky, CEO of BioLine and myself and Dr. Arnon Aharon our VP of Medical Affairs is joining us as well. Following our prepared remarks, we’ll be happy to take your questions. Most significantly, we recently reported interim results upon completion of the dose escalation stage of our Phase 2 BL-8040 clinical study for treating relapsed refractory AML. If you recall in late 2014, we amended our study protocol to include additional higher dose cohorts based on the factor we hadn’t seen any safety issues at the doses tested to-date under the original protocol. We were pleased to report that the results continue to demonstrate excellent safety and tolerability up to the highest dose tested of 1.5 mgs per kg. In terms of efficacy, we continue to see evidence as BL-8040’s unique dual mechanism of action showing what we believe is best-in-class mobilization of cancer cells from the bone marrow as well as significant leukemic cell apoptosis. The expansion phase of the study is currently underway using the optimal dose of 1.5 mgs per kg although in parallel to initiation of the expansion stage since we didn’t see any dose-limiting toxicity we intend to recruit one additional cohort of patients at a higher dose level of BL-8040 to further expand BL-8040’s# therapeutic window. We expect to enroll approximately 40 patients into the expansion phase of study to ensure that a sufficient number of patients are treated at the optimal dose inclusive of those who participated in the expansion phase. We expect the expansion phase to progress much more quickly than the dose escalation stage of the trial which required approval from the Data Safety Monitoring Committee before moving to the next dosing level. In addition, we have opened additional sites for this stage of the trial to expedite the enrollments. We also announced a successful top-line safety and efficacy results from our Phase 1 study of BL-8040 with stem cell mobilization as part of an improved regimen for patients undergoing bone marrow transplant. All clinical endpoints were met in our study which shows that in addition to being safe and well-tolerated at all doses, treatment with BL-8040 as a single agent resulted in efficient stem cell mobilization and collection from all study participants following only one collection procedure. As announced, these results exceeded our expectations supporting and validating BL-8040 as a highly differentiated one day single dose regimen for collecting a high yield of stem cells from the bone marrow. This is a significant improvement upon the current standard of care which can be associated with the side-effects including bone pain. In addition, the current standard of care requires four to five days of treatment followed by one to three full day apheresis sessions with each apheresis session generally requiring between eight to twelve hours at the hospital. We believe BL-8040’s very favorable profile will be a great interest and value both medically and in terms of enhancing patient comfort. We plan to meet with the FDA as soon as practicable in order to discuss these results and obtain greater clarity and insight on a next clinical development steps for this indication. We also intend to present the full set of study results at the European Hematology Association BHA Conference taking place in Vienna next month. We expect this presentation if accepted to garner significant interest from the transplant community. At this point I’d like to turn the call over to Dr. Savitsky to discuss the upcoming clinical milestones for our BL-8040 platform as well as our second lead asset, BL-7010 for treating celiac disease and our most advanced partnered asset, BL-1040 for the prevention of cardiac remodeling following myocardial infarction. Following Dr. Savitsky’s remarks, I will provide a brief overview of our finances before opening the call to question and answers. Kinneret, please go ahead.

Thank you, Phil, and good morning to everyone. As Phil mentioned, we are focused on advancing our lead programs through value driving clinical and regulatory milestones. As an integral part of this strategy, we are particularly focused on initiating clinical studies’ design to expand our lead BL-8040 program differ into oncology and other important hematological indications. As we discussed on our previous call, and at the Special BL-8040 event we held in New York at the end of last year, we are preparing to commence three new studies in the next few months. In the coming weeks, we expect to initiate a double-blinded placebo-controlled randomized multi-center Phase 2 b study to examine BL-8040 as a novel consolidation therapy for AML patients. This study is being done in collaboration with the University of Halle with participation from two large leukemia study groups in Germany and will be conducted to about 25 sites in Germany. The regulatory submission for this study has been done and preparations are being made to enroll the first patient. A total of approximately 200 patients will be enrolled in this study which we expect to complete in 2017. In addition to the consolidation AML study, we expect to initiate a third AML trial for BL-8040 in combination with a FLT-3 inhibitor agent in patients with FLT-3, ITD mutated AML in the next few months. We will provide more detail on this Phase 2 study as we finalize the study protocol and submit the required regulatory filings. Based on our current expectations, we would also anticipate reporting interim study result in this indication in the second half of 2016. Finally, we also plan to assess BL-8040 as a novel placement for certain bone marrow failure diseases, specifically MDS and aplastic anemia. In this regard, we expect to commence a Phase 2 trial in combination with the standard-of-care immunosuppressive therapy in the next few months as well. These last two studies that I mentioned are being done in collaboration with MD. Anderson. We are very excited to explore the extended potential for BL-8040 which we believe is set becomes a market-leading hematological platform. In terms of our ongoing AML study in relapsed refractory patients, we anticipate reporting final top-line results from the ongoing expansion phase of the study in the fourth quarter of this year. As we project the results, we would expect to present the complete study results at the relevant medical conference and request an end of Phase 2 meeting with the FDA regarding this program. Finally, with respect to the next step for the stem cell mobilization program, we plan to request a Type – B meeting with the FDA regarding our positive Phase 1 safety and efficacy results and we anticipate commencing a Phase 2 study in early 2016. In addition to our BL-8040 platform, we have continued our dialogue with the EU regulatory authorities to confirm that our novel polymer BL-7010 for treating cardiac disease can be approved as a medical device in Europe. We are preparing to initiate pivotal CE Mark registration study of BL-7010 in the fourth quarter of 2015 following formal confirmation of the device regulatory pathway by the notified body and submission of our clinical trial application in a number of European countries. Currently, we are completing additional non-clinical studies and formulation works which we believe will further support advancing and potential approval of BL-7010 in Europe. Finally, regarding BL-1040, our most advanced partnered program, our partner Bellerophon had completed enrollment in the PRESERVATION 1 pivotal CE Mark registration study and enrolled patients are completing the six-month follow-up period. We continue to anticipate reporting top-line results in mid-2015. Obviously, we are excited about this result and look forward to sharing them with you. In parallel, Bellerophon is preparing to initiate the U.S. pivotal study in the first half of 2016. Bellerophon also intends to evaluate in a small study the safety of deploying BL-1040 in a primary procedure after a large standing to assess the potential for eliminating the need for a second invasive procedure currently performed. Bellerophon currently intends to begin this study in the second half of this year and they estimate that this study will take approximately one year to complete. As you can see, we had significant milestones ahead both in the near term and over the next 12 months. In addition to what I have highlighted on today’s call, we are also pursuing various collaboration agreements to further leverage our pipeline assets as well as taking additional partners to our non-core programs. In parallel to our internal pipeline development, we continue to screen at this under our strategic partnership with Novartis and we will provide timely updates on therapeutic candidates selected by Novartis if and when these promising candidates emerge. With that, I will now turn the microphone over to Phil to give the financial overview.

Thank you, Kinneret. Let me please turn your attention to the financials for the quarter ended March 31, 2015. As previously mentioned at the conference call in respect of our 2014 annual financial report, effective January 1, 2015, our functional and presentation currency was changed to the US dollar for the Israeli Shekel. Therefore, all financial information presented by the company in this call and overall will now be solely in US dollars. Research and development expenses for the three months ended March 31, 2015 were $3.2 million, an increase of $500,000, or 18% compared to $2.7 million for the three months ended March 31, 2014. The increase resulted primarily from increased spending on BL-8040 in the 2015 period, partially offset by decreased spending on BL-7010, BL-9020 and BL-5010. Sales and marketing expenses for the three months ended March 31, 2015 were $300,000, a decrease of $100,000 or 29%, compared to $400,000 for the three months ended March 31, 2014. The decrease resulted primarily from professional fees related to a number of significant business development activities that were carried out during the 2014 period, which resulted in collaboration and outlicensing agreements later in the 2014 year. General and administrative expenses for the three months ended March 31, 2015 were $900,000, a decrease of $100,000, or 14%, compared to $1 million for the three months ended March 31, 2014. The small decrease resulted primarily from exchange rate differences. The Company’s operating loss for the three months ended March 31, 2015 amounted to $4.3 million, compared to an operating loss of $4.1 million for the corresponding 2014 period. The Company recognized an immaterial amount of net non-operating expenses for the three months ended March 31, 2015, compared to net non-operating income of $1.7 million for the corresponding period 2014 period. Non-operating income for both periods primarily relates to fair-value adjustments of liabilities on account of the warrants issued in the private financings. We recognized an immaterial amount of net financial income for the three months ended March 31, 2015, compared to net financial income of $300,000 for the corresponding period in 2014 period. Net financial income and expenses for the 2015 period primarily relates to investment income earned on our bank deposits, as well as banking fees. The 2014 period also includes exchange rate differences primarily relating to changes in the US dollar New Israeli Shekel exchange rates. The Company’s net loss for the three months ended March 31, 2015 amounted to $4.3 million, compared with a net loss of $2.1 million for the corresponding 2014 period. At March 31, 2015, we had a strong balance sheet with $57.5 million in cash, cash equivalents and short-term bank deposits providing us with a cash runway of over three years to carry out our operating plans. From a corporate perspective, we recently announced our intention to carry out a one to ten reverse split of our ordinary shares traded in Tel Aviv. There may have been some confusion as to the nature of this transaction which we view surely as a housekeeping item just to emphasize the sole purpose of this reverse share split is to provide for a one-for-one ratio of our ordinary shares traded in Tel Aviv with our American depository shares traded on NASDAQ, thus preventing any confusion in the market due to the current 10:1 ratio of ordinary shares to ADSs. We look forward to finalizing this matter in the next few weeks. That concludes the formal part of our presentation. Operator, we are now opening up the call for questions.

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

Hi, thanks for taking the question. It’s actually Jason McCarthy for Jason Kolbert. And I wanted to go back to the BL-8040 platform and it really does look like it’s becoming a platform and can you discuss the relevance of BL-8040 in non-AML indications like MDS in aplastic anemia? And why these indications maybe more likely to respond to BL-8040, is there higher TXCR 4 expression relative to other blood born disorders and maybe what other disorders or blood born disorders could you use BL-8040 for?

Okay. Thanks, Jason. I’ll answer that. Thanks for the question. Actually, what we are looking rear in the bone marrow failure diseases aplastic anemia and hypoplastic MDS are situations in which bone marrow failure results in decreased blood count of white blood cells, red blood cells and also platelets. This is one of the mechanisms of action that BL-8040 has in terms of differentiation of promoting of those progenitor cells become more mature than producing more of those red blood cells, white blood cells or potentially platelets. There is a correlation between six year four and the differentiation of those progenitor cells and mainly what we are looking for is to allow those cells that are within the bone marrow niches into bone marrow to sort of waken up and start differentiating into more mature cells by then affecting those bone marrow failure diseases. So it’s not a mechanism which is similar to the one we look for in the anti-AML studies. It’s a different mechanism, it’s different doses that does that. So, we believe that this is another angle of our platform for hematological diseases.

So more than inducing hepo doses and stem cell migration it’s actually driving differentiation, that’s what you are saying?

Yes, that’s correct.

Great.

Because it’s some data in our ongoing study, for example, elevation in the platelets and so we do have some clinical evidence.

We do have pre-clinical data, this is same as clinical data which is site-clinical data from our AML study that actually validates the hypothesis that this can be done. We are now attracting the right population with the right dose of treatment to try and correlate that with the clinical benefit.

Great. And I was just looking at BL-8040, you are moving off towards consolidation therapy in the upcoming Phase 2b study. Do you see that’s going all the way up the ladder towards induction therapy and front-line treatment?

That’s a great question. In absence the answer to that, is by the end of the day, perhaps yes. But at this point in time, with the AML arena, the induction treatment is quite successful and quite straightforward across continents and across countries. So, we are targeting the unmet needs first, but down the road, when we are getting to more definitive studies, induction is an option although not the first one.

Great. Thank you very much. It sounds like everything is going really well.

Thank you.

The next question is from Assaf Vestin of Roth Capital Partners. Please go ahead.

Hi, good morning. Thanks for taking the question. So I have a question about the BL-70 product. So with regards to the US study, you stated before that it will focus on symptomatic patients which I believe the ratio is 30% of patients. I am wondering why this changed from the European study and wouldn’t treating symptomatic patients be either too late or wouldn’t be a group of patients that’s to hard to show efficacy? And do you have any data on symptomatic patients from your Phase 1, 2 study that’s already done?

Okay, thanks, Assaf, for the question. Let me try and paint the picture for BL-80 – BL-7010. What we are looking in the European study is, at the standard challenge study meaning patients that are not symptomatic that are stable on gluten free diet which we expose to a very controlled amount of gluten and then we biopsy them before and after treatment and hopefully would like to see that BL-7010 protects their intestine lining from the development of celiac related symptom. So for Europe, we are targeting non-symptomatic patients and the reason we can do that is because, BL7010 will likely be classified in Europe as a medical device. So a pivotal study for a medical device classification can be group of challenge study, that’s for Europe. When we go down to the US, the population changes and the reason the population changes is more regulatory than anything else. The FDA at this point in time insists that all GI products will be developed based on a clinical benefit for the patient. For celiac patients’ clinical benefit means, a PRO, patient reported outcome which is a questionnaire. They will not accept improvement of biopsies as primary endpoint. That is the reason why all celiac treatments that are done in the US are targeting a subset of the population which are symptomatic ones only because these are the only ones in which you can actually prove alleviation of symptom. So our target is there will be to identify patients that are symptomatic on top of gluten free diet. The reason usually that those patients are symptomatic although they maintain a gluten free diet, is accidental exposure to gliadin and gluten. And what we would like to do in all other treatments in the celiac arena would like to do, is actually prevent the exposure for those smaller amounts of gluten that you accidentally are exposed to by that, alleviate the symptom and help the patient. So that’s the difference between US and Europe.

Great. That’s very helpful. Thank you. And just one short follow-up. Do you believe – are you going to try and you get a device that is celiac as well? Do you believe that’s something that you should try and do that?

Well, we have analyzed our data and the environment around the FDA in regards to device classification and it’s our belief that in the US, BL-7010 will be categorized as drug.

Drug, okay, great. Thank you very much.

You are welcome.

[Operator Instructions] There are no further questions at this time. Before I ask Dr. Kinneret Savitsky to go ahead with her 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 1877-456-0009. In Israel, please call, 039-255-944. Internationally, please call 9723-925-5944. 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 have achieved meaningful success in our lead clinical development programs and we continue to advance and expand into business areas that we believe will add significant value to our pipeline. We demonstrated additional clinical evidence for BL-8040’s best-in-class Mechanism of Action in AML, as well as stem cell mobilization and solidified our plan to expand into several new indications for this unique oncology platform. Based on this progress, we are looking forward to many key inflection points that we anticipate will drive value for BioLine over the next months and beyond. In addition to initiating three new studies in the next few months for BL-8040, we expect to announce full data for our recently completed stem cell mobilization study at the EHA Conference in June as well as final top-line data from our core AML study in the fourth quarter of this year. We will also meet with the FDA to discuss our stem cell mobilization program to determine the clinical development plans for these indications and intend to initiate a Phase 2 study in the first quarter of 2016. In addition to our celiac program, BL-7010 remains on track to proceed to a pivotal CE-mark registration study in Europe in the fourth quarter of this year. Finally, we look forward to announcing pivotal data with our partner Bellerophon for BL-1040 in mid-2015. Thank you and good-bye.

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