Bioline RX Ltd. (NASDAQ:BLRX)
Q2 2014 Earnings Conference Call
August 6, 2014 10:00 AM ET
Josh Drumm – IR
Phil Serlin – CFO and COO
Kinneret Savitsky – CEO
Jason Kolbert – Maxim
Deanna Bahel – ROTH Capital
Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRX second quarter 2014 conference call. All participants are present in a listen-only mode. Following the management’s formal presentation, instructions will be given for the question-and-answer session. (Operator Instruction) I will now turn the call over to Josh Drumm of Tiberend Strategic Advisors to read the Safe Harbor Statement. John, 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 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 thank you all for joining us this morning. Before I begin, I just want to point out that part of our call this morning will be accompanied by a brief slide presentation. We filed the presentation about 15 minutes, so you can find it on the SEC’s EDGAR website or in the sec filings listed in the investors section of our website, www.biolinerx.com.
Joining the call today with Dr. Kinneret Savitsky, CEO of BioLineRx and me is Dr. Arnon Aharon, the company’s VP of Medical Affairs. Before we start, I would like to make some general comments on the quarter before addressing the slide presentation and the second half of this call.
As we indicated on our previous conference call, the second quarter was relatively quiet in terms of news as BioLine focused on continuing to advance our relief clinical programs, which now have significant milestones anticipated in the near and mid term. We’ll provide an overview of those upcoming milestones on today’s call as well as recap the more substantive announcements we made recently, the most significant of which being the unblinded results from our phase one, two safety study of BL-7010 for treating celiac disease.
Last quarter, we reiterated our overall strategy of focusing all the resources on our most advanced clinical programs and moving them forward as efficiently and expeditiously as possible. We have stayed true to that strategy and plan to continue our aggressive approach, hopefully delivering clinical results that meet or exceed our expectations and add significant value through our pipeline as a whole.
We deliberately have gone after high value in orphan drug opportunities which we believe will translate into significant partnership interests once we’ve achieved our planned clinical goals.
In parallel, we continue to leverage our deep expertise and extensive academic network to identify promising therapeutic opportunities for end licensing. In late June, we announced that we had in licensed a novel compound for treating neuropathic pain from the University of Colorado at Bolder we named BL-1110.
We had done some work with this compound previous under our early development program and found that is works through a novel mechanism of action to effectively potentiate the analgesic effect of classic opioid pain killers such as morphine.
Based on positive early preclinical findings, we plan to develop BL-1110 for neuropathic pain and potentially the autoimmune skin condition scleroderma. We’re not going to spend any more time talking about BL-1110 on today’s call but we view it as a welcome and promising addition to our early stage pipeline.
With that, I’ll hand the call over to Kinneret who will provide an overview of our upcoming clinical milestones and the move into the slide presentation for some additional detail on these and other select programs from our pipeline.
Thank you, Phil, and good morning, everyone. As we mentioned, BioLine is focused primarily on our lead clinical candidates in oncology and immunology. These are BL-8040 for the treatment of acute myeloid leukemia or AML, stem cell mobilization and other hematological indications and BL-7010 for the treatment of celiac disease.
Major milestones for BL-8040, our most robust inhouse clinical asset, include reporting final data from our ongoing phase two study in AML, which we anticipate in early 2015, initiating the phase one clinical study of BL-8040 for stem cell mobilization, which is anticipated to begin in the next four to six weeks with results available in late 2014 or early 2015.
And finally, we expect Professor (Nadler) to commence his investigator initiated study, phase one-two study in CML by the end of the year.
We view these events as the primary value drivers for the BL-8040 program and we look forward to providing further updates as we approach these important milestones. To remind you, we have already received orphan drug designation for AML and stem cell mobilization and we believe this is very important to accelerating the regulatory test for BL-8040 in this indication.
As Phil mentioned, we recently announced encouraging unblinded safety results from the repeated dosing phase of our ongoing phase one-two study of BL-7010 for the treatment of celiac disease.
I will briefly review the finding of this study later in this call but we are pleased to say that based on these initial safety results, we are continuing to advance BL-7010 toward the randomized efficacy study, which we anticipate will begin in early 2015.
As I’ll discuss in further detail, we are currently enrolling additional lower repeated dose of cohorts and expect to report data from those patients in the fourth quarter of this year.
As you can see, the next six months or so should promise to be very exciting for BioLine. We look forward to continue successful execution on our clinical plan and to reporting what we hope will be the transformative results. I’d like to turn your attention now to the slides accompanying this call for a more detailed review of our primary development program.
As you can see, on Slide 3, our current pipeline is quite robust, consisting of the lead program I just discussed as well as additional partners and unpartnered development stage programs. We have many opportunities to address important diseases and add value for our shareholders by bringing these assets to a stage where they can be partnered successfully for late stage clinical development and commercialization.
Before I move on to our program overview, I will say a few words regarding our most advanced partner program, BL-1040, which is in the midst of finishing a pivotal C mark registration study in the hands of our partner Bellerophon. We do not have a significant clinical update from our May conference call but there have been other developments within Bellerophon that we feel are positive and meaningful.
If you turn to Slide 5, the placebo-controlled study has enrolled over 200 out of the planned 300 patients. We continue to anticipate Bellerophon will complete patient enrollment by the end of the year and complete the study following the six months follow-up period around mid 2015.
We continue to engage in discussion with Bellerophon relating to its performance under the BL-1040 licensing agreement. So far, these discussions have remained constructive and we continue to hope for a friendly resolution of the outstanding issues with Bellerophon without the need for further escalation.
On a positive note, in early July, Bellerophon named Jonathan Peacock as the Chairman and CEO. Mr. Peacock was previously Chief Financial Officer of Amgen. Based on his strong leadership background in the pharma industry, we view Mr. Peacock’s appointment as a positive signal for the future development of BL-1040. We look forward to working with Mr. Peacock going forward. Let’s turn now to Slide 6.
Slide 6 describes a (short) peptide, which antagonist CXCR4, our BL-8040 program. It’s a platform for many hematological indications, mainly cancer. We have robust preclinical and clinical data in which we showed apoptosis and robust mobilization. We have a very strong IP position for this program and, as we mentioned before, we received form the FDA the orphan designation for both AML and stem cell mobilization.
We are now in the midst of a phase two in AML patients refractory and relapsed AML patients. This study is under an (IMD). In December of last year, we announced promising partial results from the escalating part of the study. In June and July of this year, we presented (inaudible) Hematology Association and in the Gordon Research Conferences in which we showed a synergist effect with AC220, which a sleek (three ammotated) cells. We also showed significant reduction of bone marrow cancer cells and also that BL-8040 can protect normal white blood cells.
The phase two study in AML is running in full steam towards the completion of the escalating phase and in early 2015 the study will be completed. Let’s turn now to Slide 7.
The stem cell mobilization study, in June we announced that we received the Israeli Ministry of Health approval to start the study. The study is going to conduct in (that) hospital. Within the next month or so we are going to start the study to recruit the first patient in. We already initiated the study in this site.
These studies consist of two stages. Part one is a dose escalation study of 32 volunteers, healthy volunteers. It’s a placebo-controlled study and we’re going to identify the optimal dose to continue to part two in which we will recruit eight more healthy volunteers in the optimal dose and this part we are going to check efficacy and to try and quantify the stem cell mobilization based on BL-8040. The results of this study is expected late this year or early next year.
Regarding the CML investigator initiated phase one-two study, this study is conducted in the Sheba Medical Center. We received approval from the Israeli Ministry of Health and we expect to start recruitment this year. It’s a randomized dose escalation study combined with standards of care up to 40 patients. The primary endpoint is safety and tolerability of the combination and the secondary endpoint is efficacy. We are looking for cytogenetic and molecular response in these patients.
Let’s turn now to Slide 8. This is our celiac program, BL-7010. We do see, as I mentioned in the previous calls, an increased interest of pharma companies in celiac. There are only three clinical programs for celiac today around the world.
We are now running a phase one-two study in which we are looking for safety and tolerability but also for (PK). In March this year, we completed a dose escalation stage. We reached the highest planned dose without dose-limiting toxicity.
In July this year, we reported unblinded data of the repeated dose stage. This was a 14 repeated administration three times per day. No serious or dose-limiting toxicity was revealed during this stage. No systemic exposure which is extremely important since based on our previous discussions with a notified body. We believe that this has a good chance to receive a device designation which will probably accelerate the development and commercialization of the program.
We did see some minor GI adverse events. I have to say that although this is mild and we can continue to the efficacy stage, based on our therapeutic window we decided to add more cohorts and try and check lower doses of BL-7010 as well. The results of the additional cohorts is expected in the next few months. The efficacy study is expected to start in 2015 and this will be a placebo-controlled study.
That concludes our program update. I will now turn the microphone over to Phil to give the financial overview. Phil, please go ahead.
Thank you, Kinneret. I’ll now turn to Slide 9 which is the beginning of the second quarter 2014 financial review. On Slide 10 you can see that we’ve got a strong current cash position. We had $33.1 million as of June 30, 2014. This amount of money will fund our operational capital through the end of 2016 and we expect to reach several value inflection points during this period of time.
We have a broad US institutional investor base and US investors now hold roughly two-thirds of our total shares outstanding and we’re presenting at a number of upcoming conferences. From a financial conference perspective, we’re going to be presenting at the Rodman Conference in New York in September. We’ll also be presenting at the Zacks Conference in Basel, Switzerland in September and at the Biotech Showcase Conference in San Francisco in January.
In addition, we have a number of scientific conferences that we’re going to be presenting at and I invite all of you to visit our website where you can get more information on those conferences.
I’ll now turn to Slide 11. All of the amounts, by the way, that I’m going to be referring to in the next slide or two are based on a translation of the Sheqel amounts into US dollars based on the June 30, 2014 exchange rate.
So our total R&D expenses decreased by about $5.3 million to $5.6 million for the six months ended June 30, 2014. And this significant decrease primarily relates to the termination of the BL-1020 clarity study in March of 2013 as well as certain one-time costs associated with a number of our other clinical stage projects in 2013. And this decrease was partially offset by increased spending on our celiac program.
Sales and marketing expenses increased by about $200,000 to $700,000 for the six months ended June 30, 2014 and this results from increased business development activities as reflected in some additions… increase in our professional fees.
If you’ll turn to Slide 12, G&A expenses decreased by about $200,000 to $1.9 million for the six months ended June 30, 2014 and that’s primarily due to one-time expense for professional services in the 2013 period.
Our non-operating income decreased by about $2 million to $2 million for the six months ended June 30, 2014 and that primarily stems from a fair value adjustment related to our warrant liability.
Financial income and expenses were $200,000 for the six months ended June 30, 2014 compared to about $500,000 for the 2013 period and those changes resulted primarily from changes in the average exchange rate of the Sheqel to the US dollars.
If you’ll turn to the last slide, Slide 13, we always say that this is probably our most significant slide. It shows all of our major development milestones over the next 12 months. I will point out that it does not include any potential commercial milestones that we may have but simply focuses on the development milestones.
And if you’ll look, for example, on the right side of the slide in beige, you will see that our phase two in AML for BL-8040, we should have some partial results in the second half of this year and then we should have phase two complete results sometimes early next year as Kinneret pointed out earlier.
If you’ll look sort of the light orange, that’s our stem cell mobilization study, our phase one study for BL-8040 and we should be initiating that study, commencing that study in the next month or two. That study should be completed by the end of this year or the beginning of next year.
We also have the CML study in BL-8040 as we mentioned, that phase one-two study and that should be initiating sometime between now and the end of this year. If you’ll turn to the left side of this slide in purple, you’ll see there are a number of milestones for BL-7010 for celiac disease.
We should be completing the phase one-two after we have the additional cohort sometime in the next month or two. We should be starting a pivotal study for the celiac disease program and efficacy study by the beginning of next year. We’re also expecting to have a pre-IND meeting with the FDA for the US development pathway sometime in the first half of next year and we hope to start the US efficacy study sometime in the second half of next year.
Finally, we can’t forget the BL-1040 program to prevent ventricular remodeling after AMI, which is being run by our partner Bellerophon. As we indicated, we hope that that study will complete enrollment by the end of this year and that the study should be completed by the middle of next year.
So as you can see, we have quite a number of very, very significant milestones over the next 12 months. This concludes the formal part of our presentation. Operator, we are now opening up the call to questions.
Thank you. Ladies and gentlemen, at this time, we will begin the question-and-answer session. (Operator Instructions) The first question is from Raghuram Selvaraju from Aegis Capital. Please go ahead. Hello? First question from Raghuram Selvaraju from Aegis Capital? Okay. We’ll move on to the next question from Json Kolbert of Maxim. Please go ahead.
Jason Kolbert – Maxim
Hi, guys. Thanks for the very comprehensive rundown. Can you help me understand when we talk about BL-7010 data and completion of the phase one-two studies, what forum that data might be announced and at what point do we get a kind of definitive plan on how we move that program forward?
Okay. So I’ll start and then Dr. (Nolan) will continue. The data that we will present will be after conducting the next cohort, what we saw from the cohort, if there were any adverse events and whether we are entitled to continue to the next study.
Jason Kolbert – Maxim
And can you lay out for me what you think the outline will be for the next study and how you would move that forward on your own or with a partner and how the partnering… at what point does a partner step in to this product?
Yes. So (Nolan) will answer the first part of the question and then I will add regarding the commercialization.
In terms of the design of the efficacy study, that will be a gluten challenge study. We will be treating subjects the celiac patients that are stable on a gluten-free diet and we will expose them to a pre-defined amount of gluten and will by that time compare the effect of BL-7010 to a placebo when given over a period of six weeks to those subjects.
Following that period, we’ll check to see whether any damage to their intestinal gut lining will develop or not and if and when BL-7010 will offer protection from such damage from a controlled amount of gluten given daily.
Regarding the commercialization, we are not going to start actively looking for a partner before we have efficacy data. Having said that, since the celiac space is attracting more and more companies, we are being approached by companies but this is not our intention at this point.
Jason Kolbert – Maxim
Okay. Thank you very much. And I’d just like to switch gears now and talk a little bit about the AMI study, BL-1040. As I’m looking at Slide 13, I see that at the end of the year we kind of complete the CE mark study enrollment. So can you just take some time and review with me what the endpoint, which is I believe in six months a composite of multiple factors. And help us understand how those negotiations with (NYSE:D) regulators might move forward so that we can understand the timeline towards approval.
So the primary endpoint of this study is end systolic volume and then the two secondary efficacy endpoints are the six minute walk, which is the clinical endpoint and the quality life questionnaire, the Kansas City questionnaire. These are the efficacy endpoints besides the safety and tolerability endpoints.
So at the end of the year we’re going to finish the recruitment. There is a six months follow up. This is why we expect the study to end around mid next year. And then we will start… well, Bellerophon will start the C mark process. So the C process did not start yet. We are getting ready with the manufacturing reporting and all of the data that needs to be completed before the C mark process starts.
Jason Kolbert – Maxim
Thank you and that’s very helpful. But just… I’d like to dial in a little bit tighter which is if we were talking about the US regulatory landscape, there would be questions about whether KCCQ would be an approval endpoint for commercialization. And so can you just remind me what discussions (Ballero) or you have had with them in terms of the acceptance of this as an endpoint both systolic volume, quality of like, six minute walk tossed and KCCQ, which is such a… which, by the way, I believe is an excellent composite endpoint versus what US regulators might want, which at this point is not clear? It would probably be mortality, though. So help me understand do you think you’re approvable without a mortality endpoint in Europe?
So I can’t disclose this information. These are discussions that Bellerophon conduct with agency, with the FDA, so I’m sorry. I cannot disclose this information.
Jason Kolbert – Maxim
Okay. Well, maybe we can take it up at some other time. Thank you very much for the update.
The next question from Joe Pantginis of ROTH Capital. Please go ahead.
Deanna Bahel – ROTH Capital
Hey, guys, it’s Deanna Bahel in for Joe. Just wondering if you can give us a little more detail on the development plan for 1110 with your main focuses on oncology and immunology mentioned you might look to partner that drug sooner rather than later and obviously the end licensing was pretty recent but can you comment on whether you’ve had any interest from potential partners and also whether you’re still looking to have a pre-IND meeting and when that might take place?
Yeah. So this project was earlier in our early development program, so we are familiar with the compound for neuropathic pain. And we believe that since it has a new MOA, we believe that we’ll be able to out license this project relatively in early stage.
Having said that, we are still in early preclinical studies, so it’s a bit too early to discuss when exactly is the best timing to out license it.
Deanna Bahel – ROTH Capital
Okay, thank you.
(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 being two hours after the conference. In the US, please call 1-888-295-2634. In Israel, please call 03-925-5929. Internationally, please call 972-3-925-5929. Dr. Savitsky, would you like to make a concluding statement?
Yes. I want to thank all of you for joining us today. We remain very focused on achieving our upcoming clinical milestones toward the end of the year and into early next year.
As Phil highlighted, we are very well funded to continue executing on our clinical strategy with the main goal of attracting potential partners and driving optimal evaluations for our lead programs.
Above our, our sizeable pipeline remains strong and competitive in the relevant therapeutic areas, which we expect will continue to drive long-term value for a buyer line for years to come.
We look forward to keeping the market updated on our progress and thank you, again, for joining us today and for your continued support. Good-bye.
Thank you. This concludes the BioLineRX second quarter 2014 conference call. Thank you for your participation. You may go ahead and disconnect.
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