BioLineRx Ltd. (BLRX) Earnings Call Transcript & Summary

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First Quarter 2021 Results Conference Call. [Operator Instructions] I would now like to turn over the call 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 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 earnings conference call today. Earlier this morning, we issued our Q1 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. 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 Abi Vainstein, our Chief Medical Officer; and Ella Sorani, our Chief Development Officer. Our most meaningful achievements since our last quarterly update is our most recent. Just a few weeks ago, we announced extremely positive top line results from our Phase III clinical trial, evaluating our lead clinical candidate Motixafortide in stem-cell mobilization for multiple myeloma patients undergoing autologous hematopoietic stem cell transplantation. Recapping the unmet need, patients undergoing autologous transplantation generally require multiple administrations of G-CSF and the current standard of care and up to 4 apheresis sessions in order to collect the target number of stem cells required for transplantation. In addition, it is estimated that between 30% and 50% of patients are poor mobilizers, not only necessitating multiple apheresis sessions, but requiring, on top of G-CSF, 1 to 4 daily injections of plerixafor. The main objectives of this study was to demonstrate that Motixafortide on top of G-CSF provides superior mobilization relative to the current standard of care, resulting in more collected cells, fewer doses and fewer apheresis sessions. This has significant clinical benefits to patients since the apheresis sessions are long between 4 and 6 hours each and difficult. And the need for fewer injections and apheresis sessions is likely to significantly reduce overall risk of mobilization-related adverse events. In addition, this also has economic benefits to health care payers since apheresis sessions are costly. So the more days that can be eliminated, the stronger the pharmacoeconomic case to be made for Motixafortide as the backbone of a new stem-cell mobilization treatment paradigm. To that end, we are currently running a pharmacoeconomic study to support this cost benefit analysis, which we hope that health care payers will ultimately find compelling. The data demonstrated that the study successfully met all primary and secondary endpoints with an exceptionally high level of statistical significance with a p-value of less than 0.0001. Some of the key highlights are 88.3% of patients receiving Motixafortide and G-CSF underwent transplantation after only 1 administration of Motixafortide and in only 1 apheresis session. This compares to 10.8% for G-CSF alone. Patients receiving Motixafortide plus G-CSF showed a 54.6% treatment effect and a 4.9-fold increase in the primary endpoint, mobilization of over 6 million cells per kilogram following a single dose of Motixafortide in up to 2 apheresis sessions as compared to the control arm of G-CSF alone. While not a head-to-head study, this compares very favorably to results from the registrational study of plerixafor, which demonstrated a 37.2% treatment effect and a 2.1-fold increase for the plerixafor plus G-CSF arm versus G-CSF alone. So to emphasize a 54.6% treatment effect and 4.9-fold increase in our study versus a 37.2% treatment effect and a 2.1-fold increase in the plerixafor study in the primary endpoint. The study also achieved its main secondary endpoint, the percentages of patients who mobilized over 6 million cells per kilogram following a single dose of Motixafortide on top of G-CSF and in just 1 apheresis session in an even more impressive manner. Patients in the treatment cohort of the GENESIS trial demonstrated a 61.7%treatment effect and a 14.1-fold increase as compared to the control arm of G-CSF alone. By comparison, the registrational study of plerixafor demonstrated a 36.9% treatment effect and a 3.1-fold increase for the plerixafor plus G-CSF form versus G-CSF alone. Again, to emphasize, a 61.7% treatment effect and a 14.1-fold increase in our study versus a 36.9% treatment effect and a 3.1-fold increase in the plerixafor study in the main secondary endpoint. By any measure, we believe these data demonstrate a very significant clinical benefit from adding Motixafortide to G-CSF and support Motixafortide on top of G-CSF as the new standard of care mobilization agent in autologous bone marrow transplantation. As previously mentioned, this study represents our fastest track to registration and to that end, we are very diligently working on activities in support of the U.S. New Drug application or NDA which we plan to submit in the first half of next year. If ultimately approved in this indication, we would begin our transition to a commercial stage company, the most important and transformational milestone that we will have achieved to date. Turning now to our pancratic cancer or PDAC program, recall that in December, we announced positive final results from the Phase IIa COMBAT/KEYNOTE-202 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 IV metastatic PDAC who had progressed following first-line gemcitabine-based therapy were enrolled in a triple combination arm. Data from this study demonstrated a 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, as we've previously indicated, we continue to engage in discussions with the potential biopharma partners to collaborate on a randomized controlled Phase II/III study. 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 I/IIA 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. As we have discussed, the COVID-19 pandemic did impact enrollment for a period of time, but has now resumed. We remain on track to report data in the second half of this year. I would now like to turn the call over to Mali Zeevi, our CFO, who will give a brief overview of our key first 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 reviews and press release for additional information. Research and development expenses for the quarter ended March 31, 2021, were $4.3 million, a decrease of $1.1 million compared to $5.4 million for the comparable period in 2020. The decrease resulted primarily from lower expenses associated with the Motixafortide Combat clinical trial as well as lower expenses associated with the AGI-134 study. Turning to cash, the company held $58.1 million of cash, cash equivalents and short-term bank deposits as of March 31, 2021. During the first quarter, we completed a financing that raised gross proceeds of $34.5 million, which we believe will finance the company through multiple potentially value created 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. First, initial results from Part 2 of the Phase I/IIA trial of AGI-134 in solid tumors 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 then an NDA submission for stem-cell mobilization in the first half of 2022. Of course, this list does not take into account any potential partnering or strategic transactions. And while we cannot guarantee that a transaction will ultimately come to fruition, discussions with multiple parties are ongoing. In summary, we achieved the most significant milestone in our company's history with the outstanding positive results of the Genesis study in stem-cell mobilization. We also continue to work on the advancement of our PDAC program as well as 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 then conclude the formal part of our presentation. Operator, we will now open up the call to questions.

[Operator Instructions] The first question is from Joe Pantginis of H.C. Wainwright.

Phil, I was just curious, I mean, when you look at your ongoing business development discussions, you obviously have a few things in play with regard to Motixafortide. Ahead of the NDA, you have certain commercial needs and needs manufacturing that you need to put in place. And of course, those are not going to be placed on hold, just waiting for any sort of partnering discussions. So I guess, how are you looking at the type of partnership you might want to consummate based on the indications beyond stem-cell mobilization? And the role that a potential partner might want to play in the design of a pancreatic study and other tumor indications as well?

Joe, thanks very much for joining the call. So it's not necessarily a given that we would look to partner the indications to the same partner, these are different players, these different markets, hem/onc and solid tumors. They may interest different parties. We're also looking at potential regional deals as well as global deals. So we also think that it would make sense to potentially separate the 2 products to have a solid tumor, chronic indication or administration type product and a one-off product like the stem-cell mobilization. And so we're -- as we said previously, we're looking for a collaboration partner to continue development in pancreatic cancer, the next study, the next step would be a randomized controlled Phase II or Phase II/III study, we would like to have someone help us finance it, either take it off our hands and move forward themselves in a licensing deal or some type of collaboration. So we are very much working on that and hope that something will come to fruition sometime in the near future.

No, that's good. So it definitely sounds like you have important flexibility around this. And then I was just curious regarding setting expectations for the upcoming update for 134. Are you going to be able to generate any sort of translational data at that point?

Yes. Joe, this is Ella. Yes, so definitely. We will be -- That's the plan. That's the plan to be able to present the pharmacodynamic readouts of the study.

Well, actually, I wanted to add what Ella said, that we are actually doing several biopsies and lab tests in the patients that are treated with AGI. The idea is to elucidate and further understand the biological activity of AGI and confirm the biological activity of AGI as well as to identify whether it's more efficacious or not or have more activity several in tumors.

The next question is from Mark Breidenbach of Oppenheimer.

Congrats on the progress. Just with respect to the pharmacoeconomic study you mentioned, so is that something we might see the results from later this year, presented at a conference or separately? And also, can you give us an update on regulatory plans in Europe? Have you talked at all to the EMA about the GENESIS Phase III results?

So let me take the part about the pharmacoeconomic study. Yes. So as we mentioned previously, we're deep into the pharmacoeconomic study. We hope that we will have the results of that in the next few months. And we are planning hopefully, to present it at a scientific conference later in the year. And you want to take the part. Yes, go ahead.

This is Ella. So with regards to our regulatory plans with Europe, in contrary to -- we have been discussing the GENESIS trial with extensively with the FDA, we didn't discuss it with the EMA. Our first priority now is to proceed with the NDA submission. And as Phil stated, we are planning to go to the pre-NDA meeting towards the end of this year. So we are focusing currently on that. Having said that, we, of course, plan also to meet with EMA in order to discuss it as well.

Okay. Any timing around that planned meeting?

We don't have the timing yet. I think we feel that it would be important to understand the FDA requirements in the pre-NDA meeting and take that knowledge with us when we go to the EMA.

[Operator Instructions] 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 2 hours after the conference. In the U.S., please call 1-888-295-2634. In Israel, please call 03-925-5904. Internationally, please call 972-3-925-5904. Mr. Serlin, would you like to make your concluding statement?

Yes, I would. Thank you. That concludes our call this morning. Again, we are extremely pleased with our progress, especially with the outstanding results from the GENESIS Phase III trial in stem-cell mobilization, which we believe positions Motixafortide as the potential future standard of care in this indication as a 1 dose, 1 apheresis and 90% mobilization success regimen. 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 nice day.

Thank you. This concludes the BioLineRx's First Quarter 2021 Conference Call. Thank you for your participation. You may go ahead and disconnect.