Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Third Quarter 2021 Results Conference Call. All participants are present in a listen-only mode.

Following management’s formal presentation, instructions will be given for the question-and-answer session [Operator Instruction] I would now like to turn the call over to Tim McCarthy of LifeSci Advisors. 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’s 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, Adi Vainstein, our Chief Medical Officer; and Ella Sorani, our Chief Development Officer.

I would like to begin this morning with a recap of our most recent news, the statistically significant positive results from the pharmacoeconomic study comparing Motixafortide and G-CSF to G-CSF alone, which supports the use of Motixafortide as the standard-of-care on top of G-CSF with the mobilization of stem cells in multiple myeloma patients undergoing autologous stem cell transplantation.

This study, which was preplanned was conducted as a part of the GENESIS Phase 3 study for which we reported highly statistically significant positive results back in May. At this point, it may be useful to review the GENESIS results again.

The study enrolled a total of 122 patients, of which 80 were randomized into the Motixafortide arm and 42 into the placebo arm.

The main objectives of this study were to demonstrate the Motixafortide on top of G-CSF, provide superior mobilization relative to the current standard-of-care G-CSF, resulting in more cells collected fewer doses and fewer apheresis sessions. The key highlights are worth repeating.

89% of patients receiving Motixafortide in G-CSF mobilize the optimal number of cells and subsequently underwent transplantation after only one administration of Motixafortide and in only one apheresis session. This compares to 10% for G-CSF alone.

The median number of cells collected in one apheresis session in the Motixafortide G-CSF arm was 11 million. This would allow transplant of the optimal number of cells or more after one apheresis session and still leave over enough cells to freeze for future transplantation purposes, a huge advantage.

For comparative purposes, G-CSF alone mobilized the median number of 2 million cells.

While not a head-to-head study, this compares very favorably to results from the registrational study of plerixafor, which demonstrated that 54% of patients receiving plerixafor and G-CSF mobilize the optimal number of cells and subsequently underwent transplantation after only what administration of plerixafor and in only one aphoresis session As a reminder, all primary and secondary endpoints in the GENESIS study, where achieved with an exceptionally high level of statistical significance, a P value of less than 0.0001.

We are not aware of any other mobilization therapy either currently available or in development that has been able to achieve results as strong as these. Now turning to the pharmacoeconomic analysis. First, a little background to help in better understanding the results and significant clinical benefits.

Autologous stem cell transplantation is part of the standard treatment paradigm for a number of blood cancers, including multiple myeloma, non-Hodgkin's lymphoma and other lymphomas. In eligible patients, autologous transplantations report is performed after initial induction therapy.

And in most cases requires consecutive day clinic visits for the mobilization in the aphoresis or harvesting phases. It also generally requires costly inpatient hospitalization for the conditioning chemotherapy and transplantation phases until engraftment, a process that typically takes two to four weeks.

The associated burden is therefore significant. Patients experience clinically relevant deteriorations in their quality of life during autologous transplantation and healthcare resource use throughout the autologous transplantation phases is particularly intense.

Therefore, new interventions impacting the autologous transplantation process have the potential to relieve some of the clinical and the logistical burdens for transplanted patients. The logistical burden for the aphoresis units and the financial burden for healthcare providers and payers.

Describe simply, autologous transplantation consists of, first, mobilizing the patient's own stem cells from his or her bone marrow to the peripheral blood for removing or harvesting via an aphoresis procedure. Second, freezing and storing the harvest itself until they are needed for transplantation.

Third, providing a conditioning treatment such as high dose chemotherapy or radiation to kill the remaining cancer cells the day before transplant; and finally, infusing the stored stem cells back to the patient intravenously via a catheter.

To mobilize the patient's stem cells from the bone marrow to the peripheral blood for harvesting, the current standard-of-care includes the administration of five to eight daily doses of G-CSF and the performance of one to four aphoresis sessions.

For patients unable to mobilize sufficient numbers of cells for harvesting during this primary mobilization phase rescue therapy is carried out, consisting of one to four doses of plerixafor on top of G-CSF. And the performance of an additional number of aphoresis sessions is necessary.

In light of this, an agent with superior mobilization activity like Motixafortide may significantly reduce the mobilization and harvesting burden and associated risks of the autologous transplantation process and lead to significant clinical and resource benefits. And it is this hypothesis that was tested in the pharmacoeconomic study.

The study was performed by the global Health Economics and Outcomes Research, the HEOR team of IQVIA, one of the leading global data and technology firms focusing on the healthcare sector.

The pharmacoeconomic study analyze healthcare resource utilization observed during the GENESIS trial in each of the two randomized arms, Motixafortide in combination with G-CSF with a patient number of 80 or placebo in combination with G-CSF with the patient number of 42.

Health Resource Use, known as HRU, data points collected, included the number of Motixafortide in G-CSF doses, as well as the number of aphoresis sessions performed in the primary mobilization phase, the percentage of patients needing rescue mobilization due to poor primary mobilization, including the number of aphoresis sessions needed and the number of G-CSF and plerixafor doses required.

And three, hospitalization costs related to conditioning and transplantation, including length of stay. Quality adjusted life years gained from published literature were also incorporated into the model.

Motixafortide plus G-CSF was associated with a statistically significant HRU decreased during the autologous stem cell transplantation process compared to standard-of-care G-CSF alone.

Given the higher number of mobilized cells and the lower number of aphoresis sessions, lifetime estimates showed quality adjusted life year benefits and net cost savings of approximately $17,000 not including the cost of Motixafortide versus the current standard-of-care.

We believe that the compelling cost savings identified by this rigorously designed study strongly support our view that Motixafortide in combination with G-CSF can become the new standard-of-care as an upfront or primary therapy for all multiple myeloma patients undergoing autologous M stem cell transplantation.

Together with the data from the GENESIS trial showing that nearly 90% of patients collected an optimal number of cells for transplantation following a single administration of Motixafortide and in only one aphoresis session versus less than 10% for G-CSF alone, the $17,000 cost savings demonstrated by the pharmacoeconomic study should leave substantial room in the future to optimize our pricing strategy for Motixafortide at product launch and thereafter, if approved.

I would also like to point out that fewer administrations in aphoresis session confirmed meaningful safety and time benefits to patients.

In addition, the significantly higher median number of cells collected in one aphoresis session, 11 million using Motixafortide on top of G-CSF versus 2 million for G-CSF alone, not only enables transplantation of an optimal number of cells with the potential to significantly accelerate the time to engraftment, it also permits the retention of enough cells for cryopreservation in the event that an additional transplantation is required in the future.

Also, we believe the higher levels of certainty regarding the number of aphoresis sessions required for mobilization will enable more efficient use of aphoresis units at transplantation institutions, where there is often a shortage of available machines.

The potential to put to position Motixafortide plus G-CSF as the new standard-of-care primary mobilization agent versus part of a rescue therapy regimen is significant. There are more than 45,000 autologous stem cell transplantation procedures in the U.S. and Europe annually. The global estimated market is approximately $500 million.

For reference, the current first-generation CXCR4 inhibitor plerixafor generates annual sales in excess of $250 million and the two indications for which it is approved multiple myeloma and non-Hodgkin's lymphoma. And it is primarily used as a rescue therapy treatment. In terms of next steps.

In mid December, we will attend a pre-NDA meeting with the FDA, and we hope to receive the formal minutes from the meeting by the first half of January. Assuming our meeting with the FDA is successful, we plan to submit an NDA to the FDA in the first half of next year.

Our future plans also include evaluating lifecycle management potential in other autologous stem cell mobilization indications, for example, other lymphomas, sickle cell anemia, et cetera, as well as an allogeneic transplantation indications and neutropenia and others.

So, in summary, we believe the data from the GENESIS study together with the results from this pharmacoeconomic study set Motixafortide apart from all other mobilization agents, either currently available or in development, if approved. It will represent a significant advancement in stem cell mobilization to the benefit of patients and payers alike.

As we have stated before stem cell mobilization represents our fastest path to registration, and we look forward to transitioning to accompany with the commercial stage asset is ultimately approved in 2023. Turning now to our pancreatic cancer, or PDAC program.

Recall that in December we announced positive final results from the Phase 2a COMBAT/KEYNOTE-202 triple combination study of Motixafortide in combination with Merck’s anti PD-1 KEYTRUDA and chemotherapy as a second line therapy, a total of 43 patients initially diagnosed with unresectable stage four metastatic PDAC who had progressed following first-line gemcitabine based therapy were enrolled.

Data from this study demonstrated the substantial improvement across all study endpoints as compared to historical data, including median overall survival, median progression free survival, confirmed overall response rate, overall response rate and disease control rate.

With regard to next steps for our PDAC program, as we previously indicated, we continue to engage in discussions with potential biopharma partners, with the goal of collaborating on a randomized controlled Phase 2/3 study.

Taken together the positive results that we have seen in trial to date across both stem cell mobilization and PDAC, reflect the underlying versatility of Motixafortide as the potential backbone of improved treatments for both hematological and solid tumor cancers.

We have an opportunity to highlight this fact that this year's American Society of Hematology Annual Meeting & Exposition or ASH, which is taking place December 11th to December 14. We had a total of four abstracts accepted. One is in oral presentation, and three as posters.

The oral presentation will describe the positive results from the GENESIS study, which I touched on earlier.

In addition to three poster presentations will describe; first, findings from a pooled analysis of the GENESIS trial demonstrating the correlation of higher numbers of stem cells infused with shorter time to engraftment; second, findings from a correlative study of the GENESIS trial demonstrating that Motixafortide plus G-CSF mobilized higher numbers of specific cells, enabling broad multi-lineage haematopoiesis reconstitution; and third, findings from preclinical studies demonstrating them a tech support side effects the biology of regulatory T cells, resulting in a reduction of infiltrating Tregs cells into the tumors.

Needless to say, we are very pleased to have a notable presence at such an important and prestigious medical meeting. And we believe this reflects the significant progress we have made across these two core clinical programs.

Regarding our second clinical candidate, AGI-134, recall that we are evaluating safety, tolerability and proof of mechanism in multiple solid tumor types in a Phase 1/2a study. The study is designed to evaluate a wide array of biomarkers and assessable clinical and pharmacodynamic parameters. In September, 2019, we announced positive safety data.

And later that same month, we moved quickly to initiate Part 2 to dose expansion phase. As we have discussed, the COVID-19 pandemic did impact enrollment for a period of time, but it's now resumed.

At this stage, it looks like we will complete recruitment by the end of this year and be in a position to announce results from the trial in the first half of next year. 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. As is our practice, in our financial discussion we 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 contained our financials, operating and financial review and press release for additional information.

Research and development expenses for the nine months ended September 30th, 2021 were $14.3 million, an increase of $0.8 million or 5.9% compared to $13.5 million for the comparable period in 2020.

The increase resulted primarily from an increase in expenses associated with the AGI-134 study, as well as an increase in payroll and related expenses due to company-wide accelerated actions related to the COVID-19 pandemic in the comparable 2020 period, offset by lower expenses associated with completed Motixafortide GENESIS in COMBAT clinical trial.

Turning to cash. The company held $62.2 million of cash, cash equivalents in short-term bank deposits as of September 30th, 2021. We believe we are well-financed to achieve multiple potentially value creating milestones. 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 upcoming milestones. We're giving one oral and three poster presentations at the upcoming Annual ASH Conference December 11th to 14th. We have a pre-NDA meeting set with the FDA for mid-December.

We expect to complete recruitment for Part 2 of the Phase 1/2a trial at AGA-134 in solid tumors by the end of this year. We expect initial results for Part 2 of the Phase 1/2a trial of AGI-134 in the first half of next year 2022. And we expect to make an NDA submission in stem cell mobilization to the FDA in the first half of next year 2022.

In closing, we achieved the most significant milestone in our company's history with the outstanding results of the GENESIS study in stem cell mobilization, supported by the strong positive results of the pharmacoeconomic study.

We also continue to work on the advances of our PDAC program, as well as the 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..

Thank you. Ladies and gentlemen, at this time, we will begin the question-and-answer session. [Operator Instructions] The first question is from Joe Pantginis of HC Wainwright. Please go ahead..

Hey. Good morning and thanks for taking the question. Everybody, hope you're all doing well. Phil, my questions are really forward-looking here. One in the near-term.

And I was just curious, what are the key components of your wishlist going into the upcoming pre-NDA meeting with the FDA?.

Ella, would you like to take that first? Good morning, Joe. Go ahead..

Hi, Joe. It's Ella. So, I will take this one. And so, generally speaking, since we have not disclosed it yet, but generally speaking, I think as in any pre-NDA meeting, what we want to get alignment with FDA is that the overall content of what we are going to submit is the -- acceptable for submission for NDA..

I'm sorry. I think it's about all we can say, Joe. I mean, I don't think we're going to go through each and every one of the items. But again, the idea is obviously get agreement for the FDA that we have the data and our submission is ready for submission..

Of course. And then, my next question is really focusing on AGI-134. I think the anticipation is growing for the data, obviously for this immunotherapy. And I guess assuming there -- the data are positive and you could tease something out even for a particular indications, hopefully. So, that -- I'm basing my question on a potential positive data.

But with that said, can you take any at least broad strokes with regard to the next steps and what I'm getting at here is, I don't know if you're ready to look at a potential randomized study, but there's an ongoing question, especially when you combined immunotherapies in a monotherapy -- or I'm sorry -- a combination setting, but open label setting, what the contribution is from that particular agent in a combination study.

So, I'm just wondering how you might look to address that going forward, the types of patient populations, inclusion criteria, et cetera..

Abi, would you like to take that?.

Yes. I do..

Hi, Abi..

The next step, we need to be further decide after we have the data from our study. We need to look at the patient and the patient population that we have in this basket study and see whether we can select from this special population or we can move forward in a similar way in the basket study.

We know that the next study will be a combination, and the exact combination is not yet decided. And we need to see whether we will go for a basket study again for a couple of indication. There are so many things that we need to check before we decide to move forward.

Again, I can say is, it's -- the majority of the development in the last years in an oncology, you need a combination in order to get better benefits for the patient. As far as the safety of the combination of each one of the products allow to combine them. I hope that I can help you, but it's not that much, but it is what they have at this time..

Yeah. What I definitely hear there is, depending on where the data take you, it certainly sounds like you have some flexibility that you can use for the next steps, but thanks for the color..

Okay. Thank you..

Thanks, Joe..

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

Hi, this is Jacqueline from Mark from Oppenheimer. Thanks for taking our questions. Our first question is, can you give us an update on the timing of the first data for the academic sponsored trial, Motixafortide LIBTAYO and the chemotherapy in the first line pancreatic cancer..

I guess, you are talking about the collaboration that we have with Columbia University together with Regeneron.

Actually Columbia is doing a collaboration with Regeneron and with us, is an investigator initiated trial as it stayed in pancreatic cancer with the combination of cemiplimab and Motixafortide BL-8040 and Gemcitabine in first line pancreatic cancer.

This study is conducted by -- is a principle is -- it's an investigator initiated trial and it cannot give the date of this. What I can say that we are continuing the recruitment in this trial. It is a trial with Columbia University and have another site in Brown as well. And hopefully they will be able to open another site for this study..

We have -- I think we have guided to sometime in 2022, we're still sticking with that guidance, but it does have the caveat, since we're not running the study, we have less control over it..

Okay. That makes sense. And also another question on development timeline, it looks like there has been a slight delay in AGI-134 data versus prior guidance.

Can you comment on any specific factors that contributing to the delay and can we expect the data to be delivered at a conference next year?.

Yes. Actually, there is a delay, but I think we wrap up very well in time -- in regard to the recruitment. I want to remind you that during the -- beginning of COVID pandemic, mainly in U.K.

in which we have the majority of our sites at that time, it was almost impossible to recruit patients, but not relating to the drug is more related to the operational issues in the hospital in U.K. And during this period of time, we decided to have a contingency plan and to open sites in Spain in order to overcome these difficulties in recruitment.

And indeed, we have a little bit of delay, but this delayed was much higher. It had the beginning of the pandemic. We are almost ready to complete the recruitment by the end of this year.

And I feel safe, hopefully, having data during the first half of next year, when we say for -- since that the study have a lot of biomarker assessments and a lot of data to be a -- we want to be a ready to and prepared -- with the data to present in the better way. And then we need to have a little bit of flexibility..

I think she also asked about presenting at a conference..

Conference, I cannot say that -- the issue of the conference a little bit tricky. You need to submit abstracts sometimes a half a year ahead, and it's difficult to know when we will be ready to submit this abstract and when we will be ready. At this time point, we cannot commit to present in a conference.

But we can say that we will have data during the first half of next year and we will find a way to present it..

Okay. Thanks for taking our questions..

Thank you very much..

The next question is from John Vandermosten of Zacks. Please go ahead..

Hello, everyone. And great to see that clear pathway forward on Motixafortide in stem cell mobilization, and you've got a great package of data, not only this -- just sickle, but also the pharmacoeconomic study.

What does -- do for your commercialization goals for the product? Does it make sense to go out and look for a partner who may be able to do something with this or is it something that he may want to develop internally -- or commercialize internally?.

Yeah. So, I mean -- I think, we have all options are open to us. But I think that, in general, self commercialization has not been a direction that we've been focusing on.

I think that we're looking more for a collaboration, either some type of co-promote, or some type of potential joint venture, something like that -- something like that would make much more sense to us. And we're speaking with multiple parties around this.

Again, I think that self commercialization for us sitting here in Israel and being more focusing on development would be -- would have quite a bit of operational risk and financial risk. And I think at this point, it doesn't make sense to us.

I wouldn't rule it out in the future entirely, but I think for the near future, it's not something that is likely to happen..

Okay. And you mentioned some other different areas that you could expand into in stem cell mobilization, lymphoma sickle cell.

Does it -- I mean, I guess, does that make sense for you to focus on perhaps doing some more studies in those other areas while a partner goes out and commercializes, is that sound like the strategy for Motixafortide after assuming approval?.

Yeah. It's a very good question.

There's a lot of -- I think we have to look at the potential revenues for each of these indications, both on-label and off-label, so to speak, and determine for each one, whether the investment in a Phase 3 trial is -- has a positive NPV, vis-a-vis the increase in potential revenues that we would get for having it on the label.

And I think that's something that we're going to have to evaluate with a partner for each and every one of these opportunities..

Okay. And last one for me. On the pharmacoeconomic study, I believe you mentioned $17,000, benefit. Is that -- I think that's in United States. And do you think that that's -- relative benefit is the same in Europe because Europe is another big market for that.

Will they look at it in the same way as adding a similar benefit in terms of costs, or is the cost structure different in Europe so that it's not as applicable?.

Yeah. So, definitely the cost structure in Europe is not the same as in the U.S. That's something that I -- that I can certainly say. I think we focused on the U.S. right now, this study because that's the first market that we're going for, and that's where we're going for approval.

The model that was built should be applicable to all of the territories that we may look at in the future, which is primarily Europe is the main other market in stem cell mobilization. And this model -- so this model can be used for other territories in Europe, individual countries, et cetera, et cetera.

And when, and if we get to that stage, we would obviously need to update the model using data. For example, the costs of an apheresis session in Europe are different than the cost of an apheresis session in the U.S. And so, the model would have to be updated. And I think we will still see the same.

I believe -- I can't guarantee it, but I believe we would see the same type of such a significant difference, but the number would probably be different..

Okay. Yeah. That's really beautiful. That's great that you have that model. It sounds pretty flexible. Thank you..

Thank you. Thanks for the question and have a great day..

[Operator Instructions] There are no further questions at this time. Before I asked 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 1888-295-2634. In Israel, please call 039255904.

Internationally, please call 97239255904. Mr.

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

Yes, I would. Thank you. Thank you, operator. We hope you take away from this call -- from the call this morning, the tremendous progress that we have made in recent months across our two key programs, both of which address substantial unmet needs in difficult to treat cancers.

We now have in-hand extremely positive clinical and pharmacoeconomic data in stem cell mobilization, and in very encouraging efficacy and safety data in stage four PDAC patients who have a truly dismal prognosis. All of this equates to what we believe will be a catalyst rich 2022.

We believe we are well-positioned to deliver meaningful clinical benefits to patients, while creating considerable and lasting value for our shareholders, both in the relative near-term. Thank you all very much for your continued interest in BioLineRx.

And we look forward to providing our next comprehensive update with the publication of our annual results in the February/March timeframe. Be safe and have a great day..

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