Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First Quarter 2022 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.

[Operator Instructions] 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 first quarter results conference call today. Earlier this morning, we issued a 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 an overview of our first quarter.

Then Mali Zeevi, our Chief Financial Officer, will provide a discussion of our financial results. We will then open up the call and are looking forward to your questions. Joining the call as well for Q&A are Abi Vainstein, our Chief Medical Officer; and Ella Sorani, our Chief Development Officer. I'll start with a brief introduction.

As we approach the most important milestone of the company's history, we are increasingly optimistic about the potential of Motixafortide as part of a new treatment paradigm in stem cell mobilization for multiple myeloma patients, physicians and transplant centers.

Driven by this enthusiasm, we have been working tirelessly to both prepare a new drug application and to position this therapy for a robust and successful commercial launch in 2023 if approved. Moving on to the NDA submission.

As mentioned, we are moving forward aggressively and efficiently with the completion of our NDA and remain on target for a mid-year submission consistent with what we have stated previously.

Recall that in mid-December of last year, we held a pre-NDA meeting with the FDA to obtain agreement from the agency that our single Phase 3 Genesis study would be sufficient to submit an NDA from a tech support site as a stem cell mobilization agent for autologous bone marrow transplantation in multiple myeloma patients.

Needless to say, we were very pleased that the FDA agreed that our proposed data package would be sufficient to support an NDA submission. Based on our projected timelines regarding a submission in the next few months, this would likely point to a commercial launch of Motixafortide in 2023 should it be approved.

As a brief reminder, our Genesis Phase 3 trial of Motixafortide in stem cell mobilization met all primary and secondary endpoints with a very high degree of statistical significance, a P value of less than 0.0001.

Approximately 90% of patients underwent transplantation after mobilizing the target number of stem cells following only one administration of Motixafortide and in only one aphoresis session.

In addition, patients in the Motixafortide plus G-CSF arm collected an average of approximately 11 million stem cells per kilogram in only one aphoresis session, versus approximately 2 million in the G-CSF arm.

This compelling data and specifically the higher level of certainty regarding the number of aphoresis session required for mobilization enables more efficient utilization of aphoresis units at transplantation institutions where there is often a shortage of available machines. Now, let me turn to our pre-launch activities.

In parallel to the NDA submission activities, we continue to evaluate all of our options with respect to the commercialization of Motixafortide in the U.S. In this regard, we are advancing a broad range of pre-launch activities that would be required under any commercialization scenario, whether we commercialize with a partner or independently.

Our goal is to be prepared for launch on time, and to facilitate the rapid uptake of Motixafortide. As we indicated last quarter, this opportunity is very focused and concentrated as approximately 80 transplant centers out of 212 across the United States perform roughly 80% of all stem cell transplant procedures.

Therefore, the commercialization expenses and footprint required would be limited relative to a more traditional oncology launch in a broader indication.

Given this dynamic, we continue to maintain optionality with respect to the launch of Motixafortide, either with a commercial commercialization partner or independently, and we will ultimately do what will allow us to extract the most value from this acid in the U.S. and globally. Let me now speak a little bit about our market assessment.

As we indicated last quarter, we have done some extensive analysis to understand the addressable market from Motixafortide in stem cell mobilization. This includes a market assessment that we commissioned through a well-respected third party vendor ZS associates. The conclusion is that in 2021, the value of the U.S.

stem cell mobilization market was estimated at approximately $360 million and is continuing to grow. Globally, we believe the addressable market exceeds $500 million. There are over 20,000 hematopoietic stem cell transplantations annually in the U.S.

approximately 60% of which are autologous and this number has shown continuous growth over the last several years. Within the U.S. stem cell mobilization market, multiple myeloma represents the largest opportunity approximately 58% of all autologous transplants.

Historically, G-CSF alone was the primary agent used to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent transplantation.

However, the use of G-CSF generally requires multiple aphoresis days to reach the target number of cells for collection, and in a substantial number of instances, there are still patients who remain unable to produce the target number of cells for autologous transplantation.

Furthermore, the need for multiple aphoresis increases healthcare costs, and is a logistical burden to the already busy aphoresis units, in addition to the fact that it causes an increase in the adverse events related to aphoresis procedures.

With the advancement of new induction treatment regimens for multiple myeloma patients, which generally include multiple therapeutic compounds within the combination, the subsequent risk of mobilization failure continues to increase.

To-date higher intensity three or four drug regimens have become the standard-of-care induction treatment for all autologous stem cell transplant eligible patients. Recent data have demonstrated that use of such higher intensity induction treatments can lead to impairment of stem cell mobilization.

In addition, age is a predictor of stem cell mobilization response, and elderly patients are being treated more frequently than in the past. The number of autologous transplants for the treatment of malignant diseases in older patients continues to increase.

This is evident from the last analysis conducted by the Centre for International Blood and Marrow Transplant Research, showing an increase in the annual number of autologous transplantation for multiple myeloma from approximately 3,000 in 2009, to approximately 8,000 in 2019, with patients aged 65 and over, comprising 22% of total of total patients in 2009 and increasing to 36% of total patients in 2019.

Based on the above need for better mobilization agents, growth in this market over the last few years has been driven by the increased upfront use of plerixafor plus G-CSF combination therapy to drive stem cell mobilization, especially in multiple myeloma patients. The plerixafor unit and dollar volume performance in the U.S.

over the past few years indicates increased use of the product in stem cell transplants.

And as mentioned, this dynamic has been exacerbated in recent years by the introduction of more effective and aggressive induction therapies, which on the one hand, it had had higher initial response and remission rates, but on the other hand, have negatively impacted stem cell yields even with plerixafor which on average requires at least two administrations and two aphoresis sessions in order to reach the target mobilization.

This trend highlights the ever increasing need for a better and more potent mobilizer. And we believe that is Motixafortide. In this regard.

We believe that based on its differentiated clinical data, coupled with its favorable pharmacoeconomic data, which we will recap in a moment, Motixafortide plus G-CSF has the potential to gain a significant share of the market and become a new standard-of-care for stem cell mobilization in patients undergoing autologous stem cell transplantation.

In addition longer term, we believe that our product has the potential to expand beyond multiple myeloma to other indications. Now, let me briefly talk about our pharmacoeconomic studies.

At this point, I will briefly mention the two studies we commissioned, one comparing Motixafortide against G-CSF and the second comparing Motixafortide against plerixafor.

Both of these studies were performed by the Global Health Economics and Outcomes Research, for HEOR team of IQVIA, one of the leading global providers of advanced analytics technology solutions, and clinical research in the biotech pharma industry. So they were rigorously designed and executed.

Both studies identified significant cost savings by using Motixafortide driven by its ability to optimize the mobilization and collection of stem cells, and therefore reduce the number of aphoresis sessions, in turn driving benefits to the patients, centers and payers.

Against G-CSF alone, Motixafortide plus G-CSF was associated with a statistically significant decrease in health resource utilization during the autologous stem cell transplantation process,. Given the higher number of mobilized cells and lowered number of aphoresis sessions.

Lifetime estimates showed a net cost savings of approximately $19,000 not including the cost of the Motixafortide against G-CSF alone. Against plerixafor in combination with G-CSF, IQVIA did a cross study comparison and these results even surpassed the economic benefits seen in the pharmaeconomic study versus G-CSF alone.

In this study, lifetime estimates showed a net cost savings of approximately $30,000, not including the cost of Motixafortide for Motixafortide plus G-CSF versus plerixafor plus G-CSF.

We believe that the compelling clinical data from our Phase 3 Genesis trial as well as the compelling cost savings identified by these studies strongly support our view that Motixafortide supports in combination with G-CSF can become the new standard-of-care for all multiple myeloma patients undergoing autologous stem cell transplantation at all treatment centers.

Together with the data previously mentioned 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 aphoresis session versus less than 10% for G-CSF alone.

The pharmacoeconomic studies provide a strong commercial case for the use of Motixafortide on top of G-CSF and should leave substantial room to optimize our pricing strategy from Motixafortide at product launch if approved. Now, let me briefly talk about our pancreatic cancer study.

Turning now to Motixafortide pancreatic cancer, or PDAC program, recall that we previously 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.

As a reminder, data from this study demonstrated the substantial improvement across all study endpoints as compared to historical data, including median overall survival, median progression fee 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. Turning to AGI, AGI-134 now.

Regarding our second clinical candidate, the intra-tumoral anticancer vaccine 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 assess both clinical and pharmacodynamic parameters.

In September 2019, we announced positive safety data. And later that same month, we moved quickly to initiate Part 2, the dose expansion phase. We have now completed enrollment in Part II and we plan to announce the Phase 1/2a study readout in the second half of this year consistent with our prior guidance.

To help advance this and other company activities in the field of immune-oncology, and specifically with regard to AGI-134, in December, we announced the formation of an immuno-oncology Scientific Advisory Board or SAB.

This advisory board is comprised of highly regarded thought leaders in the fields of immune-oncology intra-tumoral injections and clinical development and we are already benefiting from their unique experience and perspectives.

I would now like to turn the call over to Mali Zeevi our CFO who will give a brief overview of our key fourth 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 contain our financials, operating and financial review and press release for additional information.

Research and Development expenses for the quarter ended March 31, 2022 were $4.4 million, an increase of $0.1 million, or 3.7%, compared to $4.3 million for the comparable period in 2021.

The increase resulted primarily from an increase in expenses associated with the AGI-134 study, offset by lower expenses associated with the completed Motixafortide, Genesis and combat clinical trials. Turning to cash, the company held $50.6 million of cash, cash equivalents and short term bank deposits as of March 31, 2022.

We believe we are well financed to achieve multiple potentially value creating milestone milestones into the first half of 2024. And with that, I'll turn the call back over to Phil..

Thank you, Mali. In closing, as is our custom, I'd like to take a few moments to summaries our key upcoming milestones. First submission of an NDA to the FDA Motixafortide as a novel mobilization agent for multiple myeloma patients undergoing autologous stem cell transplantation in mid-2022.

Second, announcement of initial results for part two of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2022. And now for some slightly longer term milestones. We plan to initiate a Phase 2 study for AGI-134 in 2023. We hope for potential FDA approval from Motixafortide in 2023.

And we hope to potentially launch Motixafortide in the U.S. in stem cell mobilization in 2023. With that, we have now concluded the formal part of our presentation. Operator we will now open up the call to questions..

[Operator Instructions] The first question is from Mark Breidenbach of Oppenheimer. Please go ahead..

Thanks for taking the questions, and congrats on the quarter progress. Phil, I guess I'm just wondering if you've commissioned any European market assessment for pharmacoeconomic studies for Motixafortide and maybe you can offer some comments on the potential timeline for an [indiscernible] from Motixafortide.

Yes, so first of all, Mark, it's good to speak to. So yes, with regard to a market assessment and pharmacoeconomic study, we do plan to do that we have not yet done so. And when we do so, we will be of course, disclosing that and giving some information on that. But that is -- that is definitely something that we plan to do.

With regard to Europe in general, our approach is to complete the FDA submission. And once we've completed the FDA submission, to use that submission as part of our submission to the EU, and so that should hopefully be happening, you know, sometime, you know, later this year, early next year..

Okay, got it. And just looking at clinical trials.gov. It looks like the Columbia University study of Motixafortide in pancreatic cancer is still running. You know, I'm just wondering if they're - if we can expect to see any data from that in 2022, or maybe next year? Any clarity on that would be helpful..

Yes. So, as we disclosed in our in our public filings, we're now looking at potentially some data coming out in the second half of this year. However, I do want to say that since we're not controlling the study, and it's being done, you know, it's an investigator initiated study, we have more or less control over the timing.

So our current estimates are sometime in the second half of this year. But again, it's caveated by the fact that it's an investigator initiated study..

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

Good afternoon, Phil, Mali, how you doing? Wondering first step you made so far to fill out the commercialization process and I'm also wondering how the pitch would go to payers and providers, you know, assuming approval for Motixafortide and SCM?.

So, you would like to know what activity -- I didn't hear the first part of the question, you want to sort of know what the pre-launch activities are that we're doing right now? Is that the first part of the question?.

Yes..

Okay. So, I mean, the first one, so we're doing I mean, there are a lot of things that, you know, I think we've mentioned that we're maintaining optionality, we're speaking with potential partners, co-commercialization, commercialization partners.

But we're also looking at, you know, launching independently, and a lot will depend on the value that we believe would be -- would bring the highest amount of value for the product. And so we really have two main principles here. One is launching on time doing whatever it takes to launch on time.

And the second principle, of course, is to maximize the value of the asset. And so with that overall philosophy and approach in mind, we have initiated a number of critical activities that would be required for us to do under any circumstance.

So those are things like a supply chain partnerships, like commercial packaging, serialization, we've also initiated Medical Affairs activities, because we want to already sort of drive the key scientific messages in our areas of interest in an investigator initiated study program.

We completed our brand name selection, and we've submitted it to the FDA.

And we've also initiated branding efforts to make sure they're all in place for, you know, for those submissions, we're looking at also with a market access and activities that we're starting to initiate, for example, third party logistics, 3Pl selection, distribution, network strategy, et cetera. So we are [indiscernible] studies.

So, you know, we're moving forward with these kinds of activities that need to be done under any circumstance, so that we can, you know, whether if we partner along the way, then we'll be able to still make sure that the launch happens on time? And if not, and if we decide to go forth independently, and then of course, these are activities that must be done.

So that's the first part of your question. Can you remind me of the second part of the question.

The pitch?.

That was just -- it's just a pitch that you'd make to payers and providers, but before I ask that, actually, what about a hybrid model? Might that make sense at all? Or does it not make sense to split it up with only 80 targeted places in the U.S..

I mean that was sort of, that I think, in any event, the idea would be, I think even you know, when we're speaking with partners, obviously, this is a, this is a market that's, you know, custom-made to really focus on the top 80 institutions, because they represented the -- top 79 institutions represent over 80% of all the Stem Cell Transplantations in the U.S.

So I think that, you know, based on, you know, our discussions with also potential partners, but also just our own analyses, it makes sense to really focus on those institutions. And by the way of those institutions, we have a number of those institutions were part of our phase three trial. So we already have, you know, the physicians there.

The hospital itself, they're aware of the efficacy and the clinical benefit of our, of our drug. And then, of course, on an opportunistic basis, it would make sense to then spread out to some of the larger institutions amongst the 130 additional institutions that make up the full 212 hospitals across the U.S.

So does that answer your question?.

Yes, it does..

Okay. Now, of course --.

Just on the pitch, I guess, like the short elevator pitch that you'd make, you know..

Yes, well, the short elevator pitch would be a bit depending on how many stories there are in the building, but I have to say that one aphoresis session, we can mobilize the target number of cells, and 90% of the cases, we can give much more certainty to the aphoresis units regarding the amount of aphoresis sessions that the patients have to undergo because right now, the scheduling and logistic issues are, you know, a nightmare at these institutions.

In fact, we hear that sometimes transportations or the whole process has to be delayed because they cannot guarantee that a new patient will have, you know, a seat or a machine that they can -- that they can use. I think also the safety benefits are of course, of having lower aphoresis sessions, a very important.

I think the fact that even if you require more than one apheresis session, we because of the receptor occupancy and along with receptor occupancy of our molecule, we can get two apheresis sessions at only one administration, which is on top of G-CSF which is a huge advantage. I think that's the main elevator pitch.

You know, obviously, we're -- we believe in our studies show that we're also more cost effective. So the logistics, the clinical benefit to the patients, the cost benefit to the entire system and payers et cetera. So I think that's our main pitch..

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 in 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) 392-55904. Mr.

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

Yes, I would. Thank you, Operator. To summarize we remain on track to submit our NDA from Motixafortide and stem cell mobilization mid-year. While we in parallel advanced key pre-launch activities that would be required under any commercialization scenario.

We are maintaining full optionality with respect to the commercialization of Motixafortide in the U.S. with the ultimate goal of executing a robust launch if approved, that maximizes the value of the asset. We believe we can capture a significant share of the U.S. market estimated to be in excess of $360 million.

From both the clinical and pharmacoeconomic perspective, we believe Motixafortide on top of G-CSF can quickly become the standard-of-care in this important indication. At the same time, we are working to expand the use of Motixafortide in other indications including PDAC, and are moving forward with the development of AGI-134.

As we stated last quarter, we believe we have set the stage for a catalyst rich year that will inform the evolution of the BioLineRx portfolio. 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 great day..

Thank you. This concludes the BioLineRx first quarter 2022 conference call. Thank you for your participation you may go ahead and disconnect..