Earnings Labs

BioLineRx Ltd. (BLRX)

Q1 2019 Earnings Call· Tue, May 14, 2019

$2.69

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First Quarter 2019 Conference Call. [Operator Instructions] I would now like to turn the call over to Timothy McCarthy of LifeSci Advisors to read the Safe Harbor statement. Tim, please go ahead.

Tim McCarthy

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 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.

Phil Serlin

Analyst

Thank you, Tim and good morning everyone, and thank you for joining us on our first quarter earnings conference call today. Earlier this morning we issued our Q1 earnings press release, a copy of which is available in the investor relations section of our website. It was also filed as a 6-K. Since we recently provided a clinical update with our fourth quarter results just a few weeks ago, we're going to keep our comments brief this morning. I will begin with a brief overview of our programs and activities, enumerate our major target milestones over the next few quarters, and then Mali Zeevi, our Chief Financial Officer will provide a short discussion of our financial results. We will then open up the call to your questions. Also joining the call for Q&A are Abi Vainstein, Vice President Clinical Development; and Ella Sorani, Vice President of Research and Development. During the first quarter, we continue to advance our lean therapeutic candidates BL-8040 and AGI-134 which we are developing for the treatment of multiple cancer indications. Beginning with BL-8040 which as you know we are evaluating an eight Phase 2 or Phase 3 clinical trials in multiple oncology indications including steps of mobilization for multiple myeloma patients, acute myeloid leukemia and pancreatic cancer. One of these trials is being conducted under our ongoing collaboration with Merck and three are being conducted under our collaboration with Genentech. Our partnerships with these two leading oncology companies validate our platform and give us conviction in BL-8040 ability to play a synergistic role when combined with other therapeutic agents. And in addition to these we certainly see opportunities to enter into additional partnerships down the road and to that end we are in active discussions with other parties regarding additional collaboration opportunities and we look…

Mali Zeevi

Analyst

Thank you, Phil. In our financial discussion we will only go over few significant items on this call, research and development expenses and cash. Therefore let me invite you to review the filings we made this morning, which contain our financials, operating and financial review and press release for additional information. Research and development expenses for the quarter ended March 31, 2019 was $4.4 million as compared to $5.1 million for the comparable period in 2018, a decrease of $0.7 million or 13.4%.The decrease resulted primarily from a decrease in share based compensation. Turning to cash, the company held $40.6 for million in cash, cash equivalents and short-term bond deposit as of March 31, 2019 as compared to $30.2 million as of December 31, 2018. In February 2019 we completed the public offering with gross proceeds of $15.4 million, which provide us with a cash towards the first half of 2021, a runway of more than two years sufficient to fund our operations to our most significant clinical milestone. And with that, I will turn the call back over to Phil.

Phil Serlin

Analyst

Thank you, Mali. In closing, I would like to take a few moments to summarize our most significant upcoming data milestones through the end of 2019. These are unchanged from our last quarterly report but they are worth repeating as 2019 is potentially a catalyst rich year. First, top line results from the Phase 2 triple combo pancreatic cancer trial of BL-8040, KEYTRUDA and chemotherapy under the collaboration with Merck in the second half of this year. Also potential interim results from the Phase 2 AML, Phase 2b AML consolidation study in the second half of this year. Also initial safety results from part 1 of the Phase 1/2 a trial of AGI-134 in the second half of this year and then top line results from one or more of the solid tumor trials under collaboration with Genentech in the second half of this year or early 2020. With that, we have now concluded the formal part of our presentation. Operator, we are now opening up the call to questions.

Operator

Operator

[Operator Instructions] The first question is from Mark Breidenbach of Oppenheimer. Please go ahead.

Unidentified Analyst

Analyst

This is Matt on for Mark. Thanks for taking our questions and congrats on the progress. So Phil, maybe a quick question on 8040s label, assuming a positive Genesis outcome in myeloma. Have you started thinking of ways you might be able to expand 8040s label into additional autologous transplant indications obviously non-Hodgkin's lymphoma is probably the largest but also there’s being a lot of work done in gene therapies, immobilization for gene therapy could be another interesting indication?

Phil Serlin

Analyst

Thanks, Matt. I appreciate your question. I'll turn it over to Abi.

Abi Vainstein

Analyst

Thank you for the question. Indeed we are just working right now to have first step in barrier autologous in stem cell transplantation for multiple myeloma and the reason for that to try and to get as fast as we can to approval. Afterwards we will have the door open to move forward and expand our program to different indication as to you pointed out. A non-Hodgkin lymphoma, Hodgkin lymphoma, aplastic anemia or gene therapy everything can be done but our first milestone and the most important milestone for us is to bring BL-8040 to the market. Then we will be able to expand the program to anything that we want.

Unidentified Analyst

Analyst

And then maybe a quick question on the BLAST trial and I realize their release is being strictly controlled by the German group, but can you kind of set our expectations for what we might see in that in terms of the type and extent of the data that can be presented and then I also just wanted to clarify if the futility analysis will also be conducted at that time? Thanks.

Abi Vainstein

Analyst

I will take this one as well. You are right. The data, the study is to manage and is conducted by the German group. We are working with them very closely and working together we can say. I cannot share exactly which data we will be able to put out you know to the public and the interim analysis and whether it will be an interim analysis of futility analysis. We’re working and trying to decide which will be the best way to understand what the data is saying as been an interim analysis. And this is the reason for what we are waiting for the best time to do that. We don’t want to do these analysis before time and not having the bad debt data that we can. We are trying to manage everything that we want. We want to have the data but we want to have the best data that we can and it will be based of course in the event which are the relapse and them out of relapse and the time to relapse for the patients who are doing the study. Again, we are all the time working very closely with the German group in order to decide together which data we will analyze? What would be the best timing to do that and then we will decide together what we will be able to put out publicly and what we cannot do that.

Phil Serlin

Analyst

I’ll add Matt, I think obviously we have an interest in putting out as much data as possible. I will say that both to the public but I’ll also mention that the another use of this is under CDA to speak with partners etcetera. So we are working on sort of in both pathways as far as both the type of data that will be able to release under CDA to potential partners as well as to the market as a whole.

Operator

Operator

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

Unidentified Analyst

Analyst

This is [indiscernible] calling in for Jason McCarthy. So my first question, I would like to if you could provide us pressure on the mechanistic basis for combining BL-8040 versus chemotherapy and checkpoint and how may they synergies?

Phil Serlin

Analyst

Okay, thanks very much. If I understand, just want to make sure I understand correctly. You're asking mechanistically on how we view the triple combination in pancreatic cancer and perhaps other solid tumors, correct?

Unidentified Analyst

Analyst

Exactly, yes.

Phil Serlin

Analyst

Go ahead, Abi.

Abi Vainstein

Analyst

This is a great question because if you may recall in the past that didn’t want to combine immunotherapy with chemotherapy because they saw that they cannot work together but things move forward and just became more and more common to combine PD-1 and chemotherapy. And where is the place of the BL-8040? Here its interesting because what we are testing in our best trial in pancreatic cancer is the combination of CXCR4 maybe the BL-8040with immunotherapy for patients in which immunotherapy didn’t show an effect. And we show that the addition of BL-8040 provide the immune checkpoint in this case PD-1 inhibitor KEYTRUDA to work in this patient provide delayed of the progression of the disease in seven as per the number of patient that we have and having also a response in patients who are in general not responsive to immunotherapy. And if we - and pancreatic cancer is very difficult to treat disease. Immunotherapy and CXCR4 show activity that we need to see more and activity that chemotherapy can bring to this combination is to - by the activity of the chemotherapy itself it can bring the tumor risk, review the tumor, expose the new antigens that can increase the immune response that PD-1 will assist to improve. And look forward the BL-8040 will assist in given the PD-1 to get into the tumor tissue as well as the T-cells, the adopted T-cells and decreasing the [indiscernible] the cells or the cells who are again to treat the activity of the PD-1. It’s a little bit - I think it’s a little bit completed to maybe to understand but there are three things here BL-8040 is bringing the T-cells into the tumor and given the possibility the PD-1 to work in tumor who is actually don’t respond and responses to PD-1 activity to immunotherapy. The chemotherapy will expose this new antigen and increase immune response and we expect that it will exceed also in the reduction of the tumor. We expect to see in the combo trial for this reason more response, more stable disease at the end of the day better survival at the end of the day.

Phil Serlin

Analyst

I also want to point out that our trial the double combination of KEYTRUDA and BL-8040, we saw for the first time in the clinical setting the proof of the mechanism of action, meaning that that Abi mentioned, meaning the mobilization of the T-cells, the infiltration of the T-cells, the change in the immunosuppressive environment, these were all very well documented and seen in this trial and it gives us a lot of confidence as much as we can have in pancreatic cancer that the triple combination will see an improved response in overall survival.

Unidentified Analyst

Analyst

Well, my second question with the IFG for AGI-134 now proved in the U.S., could you give us a little bit more color on the past forward you are approaching more tumor types in the Phase 1/2a trial. After that would you look at multiple features and various cancer types?

Abi Vainstein

Analyst

Our trials right now the AGI-134 is the first unmet trial. The aim of the study is mainly to show that the injection of the AGI is safe and well tolerated and of course, we will upset a biomarker and trying to see some clinical activity but the aim of the study at least just the beginning is to see that we can inject AGI and its safe. The second part of the study we are expanding a little bit indication and the program and we will have monotherapy by which in a basket study also the aim is to try to see a clinical activity, biomarker activity and we have also decided to focus into these disease and combine this with [indiscernible] to try to see whether the addition of AGI sliced out we believe have a effect of immunotherapy has been never seen. We will improve the response in to the first patient population head and neck colorectal cancer and top of PD1 inhibitor but currently I have a very low activity or known activity for example in colorectal cancer who are inhibitors.

Operator

Operator

The next question is from Joe Pantginis of HC Wainwright. Please go ahead.

Joe Pantginis

Analyst

First on the COMBAT study, can you give us a level of the kind of data will be able to see it because it will be the first look where you only have response rate data or will you have some ability to have some biopsy and immune data at the same time as well?

Phil Serlin

Analyst

Yes, so I mean I think that we've given guidance on this already we are focusing the topline results will focus on response rates and that should be in the second half towards the end of this year. And we hope to have overall survival results sometime in mid-next year more or less again the later is I think it's probably - it means that it's working it's better for us, but we assume and it will be somewhere in the middle or early second half Q3 of next year.

Abi Vainstein

Analyst

I want to add what Phil said that together with the data on response and this is validation we will have some of the data of survival for the patients who were treated for the beginning we will able to have snapshot of progression free survival and overall survival together with a response rate but the main topline result in all the patients will be response. In regards, to the biopsies we will not assess more biopsies since we already prove the mechanism of action and we don’t want - actually there are patients here and having two biopsies in these patients is very difficult for them. And since we already proved that BL-8040 together with PD1 have effect have pharmacodynamic effect in these patients, we decided we will not continue to do biopsies in these patients.

Joe Pantginis

Analyst

And then just a follow-up on some of the logistics around the IND for AGI-134. So should we view as essentially a time zero to activating sites in the U.S. essentially now having to start the process of identifying sites and IRB approvals et cetera enable to hit first half 2020 as you said to get sites active?

Abi Vainstein

Analyst

The time zero is already passed, we're already beginning to work with the sites we have - we identified sites, we have key opinion leaders who are working with us since the beginning of the development. And we have sites engaged in this trial and of course we are - its takes time until we open them as we are beginning to work with them already and again to work 2020 we’ll able to begin recruit patients in the U.S.

Operator

Operator

There are no further questions at this time. Before I ask Mr. Phil Serlin to go ahead with his 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 1-888-782-4291. In Israel, please call 03-925-5925. Internationally, please call 972-3925-5925. Mr. Serlin would you like to make your concluding statement.

Phil Serlin

Analyst

Yes. Thank you. That concludes our call this morning. I'd like to thank you again for your continued interest in BioLineRx. And we look forward to providing future updates on good things to come. Have a great day.

Operator

Operator

Thank you. This concludes the BioLineRx first quarter 2019 results conference call. Thank you for your participation. You may go ahead and disconnect.