BioLineRx Ltd.
Q4 2020 Earnings Call Transcript

Published: 23 Feb 2021

[Operator:]

Ladies and gentlemen, thank you for standing by. Welcome to the BioLine Rx Fourth Quarter and Full Year 2020 Results Conference Call. All participants are at present in a listen-only mode. Following the management's formal presentation, instructions will be given for the question and answer session . I would now like to turn over the call to Timothy McCarthy of LifeSci Advisors to read the safe harbor statement, Tim, please go ahead.

[Timothy 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 fourth quarter earnings conference call today. Earlier this morning, we issued our Q4 results press release, a copy of which is available in the investor relations section of our Web site. It was also filed as a 6K. 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. The fourth quarter 2020 was our most significant yet as we produced positive data sets from two key programs, stem cell mobilization and metastatic pancreatic cancer, or PDAC. I would like to begin with a brief discussion of stem cell mobilization. In October, we announced positive results from pre-planned interim analysis of our GENESIS Phase 3 study, evaluating our lead clinical candidate motixafortide in stem cell mobilization for patients undergoing autologous hematopoetic stem cell transplantation. Stem cell mobilization is an area of significant unmet need as 50% to 70% of patients are poor mobilizers, necessitating multiple aphoresis sessions. In addition, a portion of these patients require one to four daily injections of mozibil on top of G-CSF, the current standard of care in order to reach the required level of stem cell mobilization and collection. The primary objective of the GENESIS study was to demonstrate that only one dose of motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize greater than 6 million CD-34 positive cells and up to two aphoresis sessions.

[Mali Zeevi:]

Thank you, Phil. In our financial discussions, 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 review and press release for additional information. Research and development expenses for the year ended December 31, 2020 were $18.2 million, a decrease of $5.2 million compared to $23.4 million for the comparable period in 2019. The decrease resulted primarily from termination of the BATTLE clinical study for motixafortide in 2019 from lower expenses associated with motixafortide COMBAT clinical trial and from lower expenses associated with the AGI-134 study, as well as a decrease in share based compensation and payroll, company wide salary reduction related to the COVID-19 pandemic. Turning to cash. The company held $22.6 million of cash, cash equivalents and short term bank deposits as of December 31, 2020. Subsequent to year end, we completed the financing that raised gross proceeds of $34.5 million and received another $9.8 million in gross proceeds from the exercise of outstanding warrants. And with that, I'll turn the call back over to Phil.

[Phil Serlin:]

Thank you, Mali. In closing as is our custom, I'd like to take a few moments to summarize our key upcoming data milestones; first, final results from the GENESIS Phase 3 study and stem cell mobilization in early Q2 of this year; second data from the Phase 1/2a study of AGI-134 in multiple solid tumor types 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 finally, an NDA submission for stem cell mobilization in the first half of 2022. In summary, we have achieved two very significant milestones during the fourth quarter with positive results of our GENESIS and COMBAT/KEYNOTE studies, suggesting that motixafortide is proving to be a versatile molecule capable of enhancing standards of care in multiple cancer types. We are pleased with our continued progress, particularly in light of the disruptions caused by the pandemic, and I look forward to providing future updates.

[Operator:]

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

[UnidentifiedAnalyst:]

It’s Dave on the line for Jason, thanks for taking my questions. So regarding the Phase 2 study in PDAC. Can you shed some color on how the toxicity profile of the combination treatment being evaluated compared to the current standard of care? And do you plan on meeting regulators in any other regions globally with regards to potential commercialization? Thanks.

[PhilSerlin:]

Avi, do you want to take the first part of that question about the toxicity?

[AviVainstein:]

and the combination of motixafortide and chemotherapy and KEYTRUDA has less toxicity in some of the parameters like neutropenia and infection, and this is based on the mechanism of action of BL-8040. And in the other parameters, we didn't see any increase in the signs, means that this combination is safe as given each one of the drugs separately. I hope this answers your question.

[PhilSerlin:]

That was the first part. The second part was whether we're considering having any discussions with regulatory authorities in this indication. Am I correct?

[UnidentifiedAnalyst:]

Yes, in other regions, like in the European Union, for example.

[PhilSerlin:]

Are you talking about in PDAC, are you talking about in stem cell mobilization?

[UnidentifiedAnalyst:]

Well, for both, for motixafortide…

[PhilSerlin:]

So I mean, right now we're focusing you know -- we're laser focused on moving forward in the US and meeting with the FDA, having the pre NDA meeting and then doing the NDA submission. We are of course contemplating discussing and moving forward with registering and speaking with the authorities in Europe, for example, but that's going to be at the next stage. Right now as a small company, we feel that it's imperative for us to move forward as quickly as possible to get the drug approved in the US. As far as the other indications, PDAC, that's something that we are considering, you know doing some kind of end of Phase 2 meeting or type C meeting. But right now, I think we're, again, laser focused on trying to develop the clinical protocol for the next study and having numerous discussions with parties that maybe collaboration partners with us on the next study.

[Operator:]

The next question is from Joe Pantginis from HC Wainwright.

[JoePantginis:]

So a couple of questions, you answered one of them already. But I guess maybe what would be a bit of your wish list for this randomized control study in PDAC? Do you think there might be an interim look that could allow you for accelerated approval ahead of finishing the entire study because of the unmet need?

[PhilSerlin:]

We think that's a possibility. It's not clear to us. We may consider. Again, a lot depends on the collaboration partner that we end up working with. It maybe a Phase 2/3 study with an interim analysis. It might be a large Phase 2 study. It's hard to say right now. I think it's something that we're probably trying to put together a couple of possibilities. Of course, since this is in an unmet medical need depending on the data, the robustness of the data, there is the possibility of getting conditional approval. But right now I think that right now, we're focusing on building the protocol and then we'll have to bring the data and see how it happens.

[JoePantginis:]

And then sticking with motixafortide, obviously, you're really having a corporate shift over the next year, as you look towards an NDA as you put it, as you said for next year. So can you describe a little bit of what I guess I would portray as very important behind the scenes activity in preparing for that NDA, and what do you think are some of the major outstanding things that you have right now and where you stand on manufacturing?

[EllaSorani:]

Yes, of course, the entire CMC tests will be submitted to FDA. We are currently -- not just the CMC, all the -- so NDA supporting activities that -- with regard to the preclinical CMC clinical pharmacology, the entire package has to be put together and prepared in a way expected in order to be able to submit it.

[AviVainstein:]

And to your question about the drug probably it’s part of the NDA submission and of course we are prepared for that as well.

[PhilSerlin:]

Yes, of course, including the validation batches and everything that is required. So, I mean, I think as I'm sure you're aware, it's a huge project and we're putting massive efforts on this. As I said, we're laser focused to move this forward as quickly as possible.

[Operator:]

There are no further questions at this time. Before I ask Mr. Phil Serlin to go ahead with his 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 US, please call [phone], in Israel, please call 03925-5904. Internationally, please call (9723) 925-5904. Mr. Serlin, will you like to make your concluding statements?

[Phil Serlin:]

Yes, I would. Thank you. This concludes our call this morning. I'd like to thank you again for your interest in BioLineRx at this critical and transformative time for our company. And we look forward to our next comprehensive update in May. Be safe and have a great day. Thank you very much for your time.

[Operator:]

Thank you. This concludes the BioLineRx' fourth quarter and full year 2020 conference call. Thank you for your participation. You may go ahead and disconnect.