BioLineRx Ltd.
Q1 2021 Earnings Call Transcript

Published: 26 May 2021

[Operator:]

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First Quarter 2021 Results Conference Call. All participants are presently in a listen-only mode. Following management’s formal presentation, instructions will be given for the question-and-answer session I would now like to turn over the call to Tim McCarthy of LifeSci Advisors. Please go ahead.

[Tim McCarthy:]

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.

[Phil Serlin:]

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 results press release, a copy of which is available in the Investor Relations section of our website. It was also filed as a 6-K. As is our custom, I will begin with some brief prepared remarks 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, Avi Vainstein, our Chief Medical Officer; and Ella Sorani, our Chief Development Officer. Our most meaningful achievements since our last quarterly update is our most recent just a few weeks ago we announced extremely positive topline results from our Phase 3 clinical trial evaluating our lead clinical candidate motixafortide in stem cell mobilization for multiple myeloma patients undergoing autologous hematopoietic stem cell transplantation. Recapping the unmet need, patients undergoing autologous transplantation generally require multiple administration’s of G-CSF, the current standard-of-care and up to four apheresis sessions in order to collect the target number of stem cells required for transplantation. In addition, it is estimated that between 30% and 50% of patients are poor mobilizers, not only necessitating multiple apheresis sessions, but requiring on top of G-CSF, 1 to 4 daily injections of plerixafor. The main objectives of this study was to demonstrate the motixafortide on top of G-CSF provides superior mobilization relative to the current standard-of-care, resulting in more cells collected, fewer doses and fewer apheresis sessions.

[Mali Zeevi:]

Thank you, Phil. As is our practice, in our financial discussion, we’ll only go over a 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 contains our financials, operating and financial overview, and press release for additional information.

[Phil Serlin:]

Thank you, Mali. In closing, as is our custom, I would like to take a few moments to summarize our key upcoming milestones. First, initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of this year, also a pre-NDA meeting with the FDA for stem cell mobilization in the second half of this year, and then an NDA submission for stem cell mobilization in the first half of 2022. Of course, this list does not take into account any potential partnering or strategic transactions, and while we cannot guarantee that a transaction will ultimately come to fruition, discussions with multiple parties are ongoing. In summary, we achieved the most significant milestone in our company’s history with the outstanding positive results of the GENESIS study in stem cell mobilization. We also continue to work on the advancement of our PDAC program, as well as AGI-134, and believe that potentially significant value creating milestones can be achieved this year and in 2022. We are pleased with our continued progress and we look forward to providing future updates. With that, we have now concluded the formal part of our presentation. Operator, we will now open up the call to questions.

[Operator:]

Thank you. The first question is from Joe Pantginis of H.C. Wainwright. Please go ahead.

[Joe Pantginis:]

Hi, everyone, and thanks for the update today. Phil, I was just curious, I mean, when you look at your ongoing business development discussions, you obviously have a few things in play with regard to motixafortide. Ahead of the NDA you have certain commercial needs and manufacturing needs that you need to put in place. And of course, those are not going to be placed on hold, just waiting for any sort of partnering discussions. So, I guess, how are you looking at the type of partnership you might want to consummate based on the indications beyond stem cell mobilization and the role that a potential partner what might want to play in the design of a pancreatic study and in other tumor indications as well?

[Phil Serlin:]

Yeah. Hi, Joe. Thanks very much for joining the call. So, it’s not necessarily a given that we would look to partner the indication to the same partner. These are different players. This is different markets, high mark in solid tumors, they may interest these different parties. We’re also looking at potential regional deals, as well as global deals. So we also think that, that it would make sense to potentially separate the two products to have a solid tumor or chronic indication or administration type product and a one-off product like the stem cell mobilization. And so we’re -- as we said previously, we’re looking for collaboration partners to continue to develop and in pancreatic cancer, the next study, the next step would be a randomized controlled Phase 2 or Phase 2/3 study. We would like to have someone help us finance it either take it off our hands and move forward themselves in a licensing deal or some type of collaboration. So we are very much working on that and hope that something will come to fruition sometime in the near-future.

[Joe Pantginis:]

No. That’s good. Thank you. So definitely sounds like you have important flexibility around this. And then, I was just curious regarding setting expectations for the upcoming update for AGI-134. Are you going to be able to generate any sort of translational data at that point?

[Ella Sorani:]

Yeah. Hi, Joe. This is Ella. Yes. So definitely. That’s the plan. That’s the plan to be able to present the pharmacodynamic readouts of the study.

[Avi Vainstein:]

We actually…

[Joe Pantginis:]

Right.

[Avi Vainstein:]

I wanted to add what Ella said, that we are actually doing several biopsies and blood tests in the patients that are treated with AGI. The idea is to elucidate and further understand the biological activity of AGI and confirm the biological activity of AGI, as well as to identified whether it’s more efficacious or no or have more activity in several tumors.

[Joe Pantginis:]

Great. Thank you very much.

[Phil Serlin:]

Thanks, Joe.

[Operator:]

The next question is from Mark Breidenbach of Oppenheimer. Please go ahead.

[Mark Breidenbach:]

Hey, guys. Thanks for taking the questions and congrats on the progress. Just with respect to the pharmaco economics study you mentioned, so is that something we might see the results from later this year presented at a conference or separately? And also, can you give us an update on regulatory plans in Europe? Have you talked at all to EMA about the GENESIS Phase 3 results? Thanks.

[Phil Serlin:]

Okay. So let me take the part about the pharmaco economic study. Yeah. So, as we mentioned previously, we’re deep into the pharmaco economic study. We hope that we will have the results of that in the next few months and we are planning, hopefully, to present it at a scientific conference later in the year.

[Ella Sorani:]

Okay. Hi. Yeah.

[Phil Serlin:]

Ella, do you want to take.

[Ella Sorani:]

Yeah. I…

[Phil Serlin:]

Okay. Go ahead.

[Ella Sorani:]

This is Ella. So with regards to our regulatory plans with Europe, in contrary to we have been discussing the GENESIS trial with extensively with the FDA. We didn’t discuss it with the EMA. Our first priority now is to proceed with the NDA submission. And as Phil stated, we are planning to go to the pre-NDA meeting toward the end of this year. So we’re focus -- focusing currently on that. Having said that, we of course plan also to meet with EMA in order to discuss it as well.

[Mark Breidenbach:]

Okay. Any timing around that plan meeting?

[Phil Serlin:]

We don’t have the timing yet. I think we feel that it would be important to understand the FDA requirements in the pre-NDA meeting and take that with that knowledge with us when we go to the EMA.

[Mark Breidenbach:]

Okay. That makes sense. All right. Thank you so much for taking the questions.

[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, 1-888-295-2634. In Israel, please call, 03-925-5904. Internationally, please call, 972-3925-5904. Mr. Serlin, would you like to make your concluding statement.

[Phil Serlin:]

Yes. I would. Thank you. That concludes our call this morning. Again, we are extremely pleased with our progress especially with the outstanding results from the GENESIS Phase 3 trial in stem cell mobilization, which we believe positions motixafortide as the potential future standard-of-care in this indication, as a one dose, one apheresis and 90% mobilization success regimen. Thank you all very much for your continued interest in BioLineRx and we look forward to providing our next comprehensive update in August. Be safe and have a nice day.

[Operator:]

Thank you. This concludes the BioLineRx first quarter 2021 conference call. Thank you for your participation. You may go ahead and disconnect.