BioLineRx Ltd.
Q3 2020 Earnings Call Transcript

Published: 23 Nov 2020

[Operator:]

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Third Quarter 2020 Results Conference Call. All participants are present in a listen-only mode. 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.

[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. 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.

[Phil Serlin:]

Thank you, Tim, and good morning, everyone. And thank you for joining us on our third quarter earnings conference call today. Earlier this morning, we issued our Q3 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. 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 Abi Vainstein, our Vice President, Clinical Development; and Ella Sorani, our Vice President, Research and Development. Our most important achievement since our last quarterly update and probably one of the most significant achievements in the company's history is about our Phase 3 GENESIS study in stem cell mobilization. At the end of October, we received the results of a pre-planned interim analysis of the study. Recall that GENESIS is a randomized, placebo-controlled, multicenter study evaluating our lead clinical candidate motixafortide in addition to the standard of care G-CSF for the mobilization of hematopoietic stem cells for transplantation in multiple myeloma patients. The primary objective of the 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 6 million or more CD34+ cells per kilogram in up to two apheresis sessions. This is an area of significant unmet need given that 50% to 70% of multiple myeloma patients are poor mobilizers and offer to require multiple apheresis sessions leading to an extensive burden for the patients and their families, as well as increased costs for the payers. The interim analysis found statistically significant evidence favoring treatment with a motixafortide in the primary endpoint. As a result, the study’s independent DMC issued a recommendation to the company that patient's enrollment be immediately stopped without the need to recruit all 177 patients originally planned for the study. In accordance with the DMC's recommendation, study enrollment is now complete at 122 patients, which is only 69% of the original target enrollment.

[Mali Zeevi:]

Thank you, Phil. In our financial discussion, I will 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 contain our financials, operating and financial review and press release for additional information. Research and development expenses for the nine months ended September 30, 2020 was $13.5 million, a decrease of $1.7 million compared to $15.2 million for the nine months ended September 30, 2019. The decrease resulted primarily from lower expenses associated with the motixafortide COMBAT clinical trial and the AGI-134 study as well a decrease in payroll and related expenses due to a company-wide salary reduction related to the COVID-19 pandemic carried out in the second and third quarters of 2020. Turning to cash, the company held $20.8 million of cash, cash equivalents and short-term bank deposits as of September 30, 2020. We reiterate our previous cash guidance that our current resources are sufficient to fund our operations through the end of 2021. And with that, I’ll turn the call back over to Phil.

[Phil Serlin:]

Thank you, Mali. In closing, as is our custom, I would like to take a few moments to summarize our key data milestones for the next 12 months to 18 months. First, full results, including overall survival, progression-free survival and overall response rate data from the COMBAT/KEYNOTE-202 Phase 2a triple combination study in the second-line PDAC by the end of this year. Final results for the GENESIS Phase 3 study in stem cell mobilization in the first half of 2021. Preliminary results from the Phase 1b study in ARDS hospitalized COVID-19 patients in the first half of 2021. Initial results from the Phase 1/2a study of AGI-134 in multiple solid tumor types in the second half of 2021.

[Operator:]

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

[Joe Pantginis:]

Hi everyone. Thanks for taking the question, and hope you’re all doing well. So, my first question is on making sure I understand the news flow around GENESIS. So, you said, we need the last patient in 100 days of follow-up and data in the first half of 2021. Are we looking at this as a single data event or do we see any interim news flow in the interim, such as, for example, how many patients we’re able to get to the right amount of mobilization after one apheresis or any other details? Thanks.

[Phil Serlin:]

Yes, thanks. Hey, Joe, thanks for the question. This will be a single event. We are not able to unlock the database until we finalize the 100 days of follow-up, et cetera, et cetera. So, we plan on having a data, data news coming out sometime in the first half of next year. And it’ll include the primary endpoint and various secondary endpoints, et cetera.

[Joe Pantginis:]

Got it. No, I appreciate that clarity. And then it is disappointing as you said about the BLAST study for AML. So, I was just curious about a couple of things that, of course, this is a bit open-ended. So first, do you have any information with regard to any impacts on any background therapies that might have impacted the study at this point? And then also in your press release, you also alluded to, potentially looking at other avenues within AML and I won’t hold you to these obviously, but I was just curious if you wanted to take some initial broad strokes with regard to avenues you might look to take?

[Phil Serlin:]

Abi, go ahead.

[Abi Vainstein:]

Yes, actually, I want to point out that this interim analysis is blinded for us, that we don’t have this final data. Therefore we are not able to see whether it’s in a specific population who respond better or not to BL-8040. This analysis – the interim analysis was done for the entire population. I want to point out that as for today, there were no combination with high-dose cytarabine or any other consolidation treatment that has been shown to be better to cytarabine or transplant for patients who get into remission after first induction treatment. It’s a very difficult bar to overcome and there is no relationship between the lack of efficacy in this treatment line and compared to other treatment lines in relapsed/refractory AML or in induction therapy AML. There are several compounds that were approved for different lines of treatment in AML, but that didn't success to have a netted value on consolidation – in consolidation treatment, compared with the well-established high-dose cytarabine and transplant. We don't expect this to affect in any way our program in relapsed/refractory AML and any other – our other programs. As you know, we were successful in the GENESIS trial, therefore we will like to beat any of the indication but it's very difficult to do this.

[Joe Pantginis:]

Yes. That's helpful. Thank you. And that's what makes the data a bit more surprising just based on what your comments on the cytarabine arm and no one really beating that at that point. But thanks for the data and I'm looking forward to the rest of the year. Thanks.

[Phil Serlin:]

Thanks, Joe.

[Operator:]

Your next question is from Mark Breidenbach with Oppenheimer. Please go ahead.

[Mark Breidenbach:]

Hey guys congrats on the progress and thanks for taking our questions. Just two for me, one on stem cell mobilization and one on PDAC program. Just with regard to the GENESIS trial, do you think 100 day post-transplant safety would satisfy kind of the minimum follow-up requirement that the FDA would want to see in a future NDA filing?

[Phil Serlin:]

Abi would you like to take that?

[Abi Vainstein:]

Actually, this is what we present to the FDA. The trial design was agreed upon with the FDA. There is not something that we bring up without discussing this with them. We actually have this interim analysis that we commit to keep blinded until the 100 days. And this is as I said before, it's agreed upon with the regulatory agencies. Therefore I don't think any problem to do that.

[Mark Breidenbach:]

Got it, got it. And with regard to the PDAC program. So I know motixafortide and atezolizumab was tested in PDAC in patients who progressed after frontline chemo, it was one of Genentech’s trials, I think one of the MORPHEUS studies, that combination didn't really show much efficacy relative to chemotherapy in their control arm. I'm just wondering if there were any major differences in the types of patients that were enrolled in the MORPHEUS study versus KEYNOTE-202. And if so would you expect second line chemo to perform very differently in either of those two patient populations?

[Abi Vainstein:]

First of all it's a different combination, it’s with PD-L1, but that doesn't mean that it would not work. What we saw in that trial, that there were no major difference between the chemotherapy arm and the combination of motixafortide and atezolizumab. We didn't show any improvement, but we confirmed that there is stabilization in some of the patients, the same way that we see for the patients with chemotherapy. The median overall survival was very similar, and this is one of the reasons – as we said, we – the combination of BL-8040 motixafortide with immune checkpoint inhibitor was the basis for the rationale that we show also in the COMBAT trial. But we think that the next step is to combine this with chemotherapy. I wish we can do this also with PD-L1 in the future, but we believe this combination is part of the COMBAT trial, as well as the trial that we are carrying out with Columbia University, also in first line, also in combination with PD-1 with cemiplimab and with chemotherapy. This is the way that we see the combination at the end of the day, but that's it.

[Mark Breidenbach:]

Okay. Got it. Thanks for taking my questions and congrats.

[Phil Serlin:]

Thanks Mark. There are no further questions, at this time before I ask Mr. Phil Serlin to go ahead with 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 [phone]. In Israel, please call 03-925-5929. Internationally, please call [phone]. Mr. Serlin, would you like to make your concluding statement?

[Phil Serlin:]

Yes, I would. Thank you. That concludes our call this morning. I'd like to thank you again for your interest in BioLineRx. And we look-forward to our next data points coming up very shortly and to our next comprehensive update in March. Be safe and have a great day.

[Operator:]

Thank you. This concludes BioLineRx Third quarter 2020 Conference Call. Thank you for your participation. You may go ahead and disconnect.