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. [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..

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' annual report on Form 20-F, quarterly reports filed in the 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..

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.

Full results for the study, including secondary and exploratory efficacy endpoints, as well as extended safety data will be announced after the last patient enrolled reaches 100 days of follow-up post transplantation, which is expected to occur in the first half of 2021.

This is an extremely important milestone for our company as stem cell mobilization is our most advanced program and our most efficient path to registration. We are thrilled that the first Phase 3 data readout from our three ongoing development programs featuring motixafortide came back overwhelmingly positive.

We are optimistic that these results will position motixafortide as the foundation of a new treatment paradigm in stem cell mobilization. Now turning to AML, recall that we have been evaluating motixafortide in a Phase 2b study known as BLAST in consolidation AML.

The double-blind, multicenter, placebo-controlled BLAST study was evaluating motixafortide plus the standard of care cytarabine compared to cytarabine alone.

Just a few days ago, our collaboration partners for this study, the German Leukemia Alliance conducted an interim analysis on 128 out of 194 planned study subjects, all of whom have completed treatment in this study.

Regrettably, upon review of the interim data, the DMC did not find a statistically significant effect in this study’s primary endpoint of relapsed free survival and recommended not to continue the study. As a result, our collaboration partners and we have made a decision to terminate this study.

The results of this interim analysis are particularly disappointing in light of the positive data from the Phase 1/2a study that we previously completed in relapsed/refractory AML.

And that study in 23 patients selected for the dose expansion phase, we observed a 39% composite complete response rate with patients receiving motixafortide, in addition to cytarabine as compared to historical data of 19% for patients treated with cytarabine alone.

Similarly, median overall survival was 10.7 months for the motixafortide plus cytarabine group as compared to historical median overall survival of 5.8 to 6.1 months for patients on cytarabine alone.

It is important to note that, over the last few decades, other treatments which have been effective in induction and/or relapsed/refractory AML have failed to show improvement in consolidation treatment.

Indeed, despite advances in treatment options across different lines in AML, and specifically in certain AML mutations, high dose cytarabine and allogeneic transplantation remain the only effective post induction treatment for more than 20 years.

We continue to believe in the relevance of CXCR4 as a viable target in AML, particularly in the relapsed/refractory AML and induction treatment lines. We will decide on next steps once we’ve had a chance to review and analyze the unblinded data from this study, including detailed biomarker and subpopulation data.

Moving onto late-stage pancreatic cancer, or PDAC, recall that we are currently evaluating motixafortide in a triple combination cohort in the ongoing Phase 2a COMBAT/KEYNOTE-202 trial that we are running under our collaboration with Merck. This cohort is evaluating motixafortide in combination with KEYTRUDA and chemotherapy as a second line therapy.

PDAC is among the most difficult cancers to treat and patients with this diagnosis have a very poor prognosis. In addition, more than 50% of PDAC patients are initially diagnosed with advanced stage IV disease, due mainly to the fact that this cancer is often relatively asymptomatic while it is metastasizing.

And these patients have a particularly poor prognosis.

The patient population in our COMBAT/KEYNOTE study are these extremely challenging patients initially diagnosed with stage IV, but we believe both the difficulty and the homogeneity of the patient population will emphasize the potential robustness of the upcoming data and increase the likelihood of repeatability in a Phase 3 study.

Recapping the highly encouraging data that we reported at the ESMO IO conference in December of last year, at which time approximately half the patients in this study, 22 out of a total of 43 patients to be exact were valuable for efficacy.

As previously mentioned, all patients enrolled were originally diagnosed with stage IV PDAC and had progressed following first-line treatment with gemcitabine based chemotherapy. The confirmed overall response rate at that time was 13.6%. The disease control rate was 77% consisting of seven partial response and 10 stable disease patients.

Median duration of clinical benefit until progression for the 17 patients with disease control was 7.8 months.

We completed the full study enrollment of 43 patients in February of this year and we are looking forward and remain on track to reporting full data from this study, including median overall survival, median progression-free survival and the final overall response rate in the next few weeks before the end of this year.

Also in PDAC, we recently announced the signing of a collaboration agreement with Columbia University for an investigator initiated Phase 2 study led by Columbia to evaluate motixafortide in combination with the anti-PD-1 cemiplimab known by its brand name Libtayo and standard of care chemotherapy gemcitabine and nab-paclitaxel.

Notably, this is an entirely new study that is evaluating this combination as a first-line treatment as compared to the COMBAT study, which is second line.

The open-label study will initially enroll 10 to 12 first-line PDAC patients and will be expanded to a total of 40 patients following an evaluation of the initial 10 to 12 patients based on predefined criteria. The primary endpoint of the study is the overall response rate.

Secondary endpoints include safety and tolerability, progression-free survival, duration of clinical benefit in the overall survival. Data from this study is anticipated in mid-2022. Finally, we recently announced an investigator initiated trial from motixafortide in patients with COVID-19 induced acute respiratory distress syndrome, or ARDS.

The open-label single arm Phase 1b study is being conducted as an investigator initiated study under a collaboration agreement with Wolfson Medical Center in Holon, Israel. And will enroll up to 25 patients hospitalized with severe ARDS, secondary to COVID-19 and other respiratory viral infections.

The study will include patients with ARDS within 72 hours of initial ventilation. Study subjects will receive motixafortide via subq injection for seven consecutive days.

Patients who remain stable or improve according to the investigators assessment may continue with a maintenance treatment of motixafortide every other day, until recovery or clinical laboratory deterioration. Patients showing clinical laboratory deterioration after the seven days of treatment will be discontinued from the study.

The primary endpoint of this study is to assess the safety of motixafortide in these patients. Exploratory endpoints include the change in ratio of arterial oxygen partial pressure to fractional inspired oxygen, the change from baseline of inflammatory biomarkers and a number of ventilation days.

A preliminary analysis is planned after 10 patients have completed the initial treatment period. We project sometime in the first half of next year. Based on the preliminary evaluation, a decision to continue or not will be made.

Prior research suggests that CXCR4 is the primary mediator of neutrophils, neutrophil, extracellular traps, or NETs, monocytes and macrophages all of which were implicated in the development of inflammatory lung symptoms from COVID-19 and other viral infections.

As a best-in-class CXCR4 inhibitor, we believe motixafortide may be of use and is very difficult to treat patient population. Regarding our second clinical candidate, recall that we are evaluating the safety and tolerability of AGI-134 at a recommended dose in multiple solid tumor types in a Phase 1/2a study.

The study is also designed to evaluate a wide array of biomarkers and to validate AGI-134’s mechanism of action. We will also assess clinical and pharmacodynamic parameters. Recall that in September 2019, we announced positive safety data and later that same month, we moved quickly to initiate Part-2, which is the dose expansion phase.

Approximately seven months ago, a decision was made to temporarily suspend enrollment in this trial, since the trial sites are located in hard hit COVID-19 areas, including the U.S., UK and Israel. We anticipated that this would lead to a nine month delay.

We have recently restarted enrollment, but we are carefully monitoring the COVID situation given the recent surge in new cases, in many parts of the world. At this point, however, we continue to expect to report data in the second half of 2021 unchanged from prior guidance.

I would now like to turn the call over to Mali Zeevi, our CFO, who will give a brief overview of our key third quarter financial statement items. Mali, please go ahead..

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..

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. And finally data from the Columbia University led Phase 2 combination study in first-line PDAC patients in mid-2022.

In summary, we achieved a hugely significant milestone for the company during the third quarter with the strikingly positive results of the interim analysis in the GENESIS study.

These results reassure us in the unique characteristics of motixafortide as a best-in-class CXCR4 antagonist, and we look forward to advancing motixafortide towards the NDA submission. Furthermore, we have additional data readouts in the coming year first and foremost, the Phase 2 COMBAT final results within the next several weeks.

We believe that motixafortide continues to prove itself as a platform capable of enhancing standards of care in multiple cancer types in lines of treatment.

So, as we look back over the last quarter, 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. With that, we have now concluded the formal part of our presentation. Operator, we will now open up the call to questions..

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

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..

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..

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?.

Abi, go ahead..

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..

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..

Thanks, Joe..

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

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?.

Abi would you like to take that?.

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..

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?.

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..

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

Thanks Mark. [Operator Instructions] 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 +1-877-456-0009. In Israel, please call 03-925-5929.

Internationally, please call +972-3-925-5929. Mr.

Serlin, would you like to make your concluding statement?.

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..

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