BioLineRx Ltd. (BLRX) Q4 2018 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Fourth Quarter and Full Year 2018 Results Conference Call. All participants are at present in a listen-only mode. Following the management's formal presentation, instructions will be given for the question-and-answer session. [Operator Instructions] I would now like to turn over the call 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's annual report on Form 20-F, quarterly reports filed in a 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. Thank you for joining us on our fourth quarter earnings conference call today. Earlier this morning we issued our Q4 earnings press release, a copy of which is available in the investor relations section of our website. It was also filed as a 6-K. Our agenda this morning is as follows, we will begin with a review of our programs and activities, enumerate our major target milestones over the next few quarters. 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 today for Q&A are Abi Vainstein, Vice President Clinical Development and Ella Sorani, Vice President of Research and Development. During the fourth quarter, we made notable progress advancing our therapeutic candidates BL-8040 and AGI-134 that we are developing both independently and in collaboration with others for the treatment of multiple cancer indications. Beginning with 8040, for those of you who may be new to the BioLineRx story, BL-8040 is a novel short peptide that functions as a high affinity antagonist to CXCR-4, a chemokine receptor whose over expression has been implicated in the progression of over 70% of all cancers. We are evaluating BL-8040 in eight Phase 2 or Phase 3 clinical trials in multiple oncology indications, including stem cell mobilization for multiple myeloma patients, acute myeloid leukemia and pancreatic cancer. One of these trials is being conducted under our ongoing collaboration with Merck, and three are being conducted under our collaboration with Genentech. Our partnerships with these two leading oncology companies validate our platform and give us conviction in BL-8040’s mechanism of action and ability to combine with various therapeutic agents. And in addition to these, we certainly see opportunities to enter into additional partnerships down the road. We continue to accumulate encouraging clinical data from BL-8040’s primary therapeutic pathways and believe it is a valuable cancer therapy platform in terms of its ability to potentially treat a broad range of cancers and at various stages of disease. In multiple clinical studies to-date in a number of indications, BL-8040 has demonstrated robust mobilization of target cells, a direct [apathetic] effect, as well as the ability to induce infiltration of T-cells into the core and periphery of solid tumors, while maintaining a favorable safety profile. We kicked off the quarter by announcing that we had revised our license agreement with Biokine Therapeutics to increase our economic stake in BL-8040 to 80% from the previous level of 60%, we licensed the exclusive worldwide rights to BL-8040 from Biokine in 2012. Given the breath of the BL-8040 pipeline and the multiple milestones and opportunities that we see for long-term value creation, we were very pleased to be able to reach this agreement. And now we'll review our development programs, beginning with stem cell mobilization, the most advanced indication in our pipeline. Recall that we previously announced positive results from the leading portion of the Genesis trial, a double blind placebo controlled Phase 3 trial comparing BL-8040 in combination with GCSF to GCSF alone, for the mobilization of hematopoietic stem cells used for autologous transplantation in multiple myeloma patients. The open label single arm lead-in period of the study was designed to include up to 30 patients. However, very encouraging efficacy and safety data after only 11 patients led the DMC to recommend moving immediately into the randomized placebo controlled part of the study, which is designed to include 177 patients in more than 25 centers. The randomized portion of the trial is ongoing and we continue to expect top line results in the second half of 2020. Our hope is that if the compelling results observed in the lead-in portion are replicated in the randomized portion of this trial, BL-8040 would be viewed as a potential game changer in stem cell mobilization, adding both clinical value to patients and Pharmacoeconomic value to payers and hospitals. Given that stem cell mobilization is our most advanced indication, we view this program as a promising tap to registration. Now turning to pancreatic cancer, during the fourth quarter we initiated the triple combination arm with a Phase 2a COMBAT/KEYNOTE-202 study under our ongoing collaboration with MERC. The trial will evaluate the safety tolerability and efficacy of BL-8040 in combination with MERC’s KEYTRUDA and chemotherapy as we look to build upon encouraging top line results of the dual combination arm that we presented at the 2018 ESMO conference in October. Those results demonstrated a disease control rate defined as patients exhibiting a response or stable disease of 34.5% for 29 evaluable subjects, including one patient with a partial response showing a 40% reduction in tumor as well as nine patients with stable disease. Meeting an overall survival in all 37 patients was 3.3 months, with the six months survival rate of 34.4%. Moreover, when evaluating the results in the 17 second line patients treated in the study meeting an overall survival was quite impressive at 7.5 months, especially for an immune-therapy only regimen versus the current approved chemotherapy regimen in second line pancreatic cancer of 6.1 months. I also note that we saw an encouraging six months survival rate of 51.1% in these second line patients. These results as mentioned give us the confidence to move forward in the triple combination arm and specifically in second line pancreatic cancer patients. With the ongoing triple combination arm, we believe the addition of chemotherapy to this promising combination will have a synergistic anti-cancer effect and we are very eager to see the top line data, which we expect in the second half of this year. On a related note subsequent to the end of the quarter we were granted FDA orphan drug designation for BL-8040 for the treatment of pancreatic cancer. This is an addition to prior orphan drug designations that we have been granted for BL-8040 in AML and stem cell mobilization. As you know, the orphan drug designation carries a number of benefits as we continue to advance BL-8040 through clinical development and we view these designations as significant value creating additions to the BL-8040 program. Now moving on to AML, we believe that BL-8040 can provide broad therapeutic coverage in the AML space with potential activity at different stages of the disease and in different patient populations. This is a key point of differentiation versus other AML compounds that are being developed. For relapse/refractory AML an indication that we are advancing independently we previously discussed the compelling overall survival data from our Phase 2a proof of concept study that we presented at the EI conference in June. These data demonstrated that the combination of BL-8040 with high dose cytarabine or HiDAC, significantly improved overall survival compared with historical data for HiDAC monotherapy and was safe and well-tolerated. We continue to monitor long-term survival data for patients in this study. Given the encouraging data, we intent to further pursue this indication and we plan to meet with the regulatory authorities during the second half of this year to discuss the optimal clinical development pathway going forward. Also in consolidation AML, we are evaluating BL-8040 in a large randomized controlled Phase 2b study in consolidation therapy for patients in first remission known as the BLAST study. An interim analysis of the data is planned in the second half of this year, with full top line data expected in 2021. I will now spend a moment providing an update on our clinical collaboration with Genentech to evaluate BL-8040 in combination with Tecentriq or atezolizumab, Genentech’s anti-PD-L1 cancer immunotherapy in three Phase 1b/2 studies, maintenance AML, pancreatic cancer and gastric cancer. These studies will evaluate the clinical response, safety and tolerability of the combination as well as multiple pharmacodynamic parameters. We continue to expect that this collaboration, which is part of Roche’s Morpheus cancer immunotherapy development platform will yield a significant amount of data, but the timing of data is uncertain. We hope to be able to provide a more substantive update on this broad collaboration in the second half of this year. Now turning to our novel cancer immunotherapy candidate AGI-134, our synthetic, intratumorally administered glycolipid compound designed to label cancer cells with alpha-Gal, which then become the target of pre-existing anti-gal antibodies. This novel mechanism of action triggers an immediate hyper acute local anti-tumor response, as well as the follow on systemic anti-tumor response, targeting both the primary injected tumor and distal secondary tumors. During the fourth quarter, we were granted FDA biological product designation, providing the company with the eligibility to obtain 12 years of market exclusivity upon approval of the product for commercial use by the FDA. We are developing AGI-134 for the treatment of solid tumors. Preclinical studies have demonstrated that treatment with AGI-134 leads to complete progression of primary tumors prevents growth of untreated distal secondary tumors and triggers the vaccine effect that may prevent the development of future metastases. Furthermore, in other preclinical studies, the combination of AGI-134 with an anti-PD-1 immune checkpoint inhibitors demonstrated a synergistic effect and protection from secondary tumor growth. During the third quarter, we initiated a Phase 1/2a study of AGI-134 in unresectable solid tumors as both the monotherapy and in combination with checkpoint inhibitors. The Phase 1 part is a dose escalation phase to assess the safety and tolerability and to determine the recommended dose for part two of this study. The second part will be a dose expansion phase comprised of three cohorts designed to assess the safety, tolerability and anti-tumor activity of AGI-134. The first cohort will investigate AGI-134 as a monotherapy in a basket cohort of multiple solid tumor types. Two additional cohorts will evaluate AGI-134 in combination with an immune checkpoint inhibitors in metastatic colorectal cancer and head and neck cancer. The study is being run in the UK and Israel with possible expansion to the U.S. and additional countries in Europe in 2019. We look forward to the initial safety results from part one of the study in the second half of this year and top line results of the monotherapy arm from part two of this study by the end of 2020. In summary, the progress that we continue to make with both of our clinical stage candidates BL-8040 and AGI-134 and the breadth of cancer indications in which they are currently being evaluated continue to attract interest from potential partners and collaborators. And while it is early we believe opportunity exists for additional partnerships that complement our current programs with Merck and Genentech. We look forward to keep you updated on our progress on this front. I would now like to turn the call over to Mali Zeevi, our CFO who will give a brief overview of our key financial statement items. Mali, please go ahead.

Thank you, Phil. In our financial discussion we will only go over 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 in 2018 were $19.8 million, an increase of $0.3 million or 1.5% compared to $19.5 million for 2017. The small increase resulted primarily from an increase in share-based compensation. Turning to cash, the company held $30.2 million in cash, cash equivalents and shorts bank deposits as of December 31, 2018. In February 2019 we completed a public offering with gross proceeds of $15.4 million, which provide us with the cash -- with the first half of 2021, a runway of almost two and half years sufficient to fund our operations through our most significant clinical milestones. And with that, I will turn the call back over to Phil.

Thank you, Mali. In closing, I would like to take a few moments to summarize our most significant upcoming data milestones through the end of 2019. First potential interim results from the Phase 2 AML consolidation study in the second half of 2019. Also initial safety results from part 1 of the Phase 1/2 a trial of AGI-134 in the second half of 2019. Also, top line results from one or more of the solid tumor trials under collaboration with Genentech by the end of 2019 or early 2020. And finally, top line results from the Phase 2 triple combo pancreatic cancer trial of BL-8040, KEYTRUDA and chemotherapy under collaboration with Merck by the end of 2019 as well. With that, we have now concluded the formal part of our presentation. Operator, we are now opening up the call to questions.

Thank you. [Operator instructions] The first question is from Jason McCarthy of Maxim. Please go ahead.

Hey, guys, thanks for taking the question. All right, so you recently presented some positive initial data from the Genesis trial, I like to see if you could just give us a quick review of the multiple myeloma treatment paradigm and see where BL-8040 and BMT may fit, especially as we see a lot of new therapies advancing including the BCMA targeting CAR-T in this clinical space.

Great, first of all, thanks for the question. Abi, would you like to take that?

Yes, no problem. Thanks, Jason. Actually, the treatment for multiple myeloma there are several aspects. First of all, bone marrow transplantation is still the standard of care treatment for patients. After they get into remission in the first treatment for them all the different treatment there are in development, the majority of them they coming after a transplant, or in patients who cannot go for transplant. Therefore, the bone marrow transplantation and the stem cell mobilization is still relevant, but it is not competing with this kind of treatment that you mentioned. The aim of our study and the BL-8040 is to try to bring the patients less to the hospital to give them less burden of treatment and preparation for the stem cell transplantation. And it's not competing with these drugs that we’ve already mentioned. Hope it answer your question.

Thank you very much. And then I just want to do a quick follow up to get an idea of the market dynamics in the space. So around how many HSCTs occur per year in multiple myeloma? And then at how many centers, is it a concentrated marketplace like we see in allogeneic side in AML or is it a bit more diffuse?

Abi, you want to take that as well?

Yes, no problem. In terms of percentage, I didn't have this right now to give you, I don't remember exactly. But again, I'm telling you, the majority of the patients who are less than 67 years old, this is the category in terms of years, but now in performance studies it’s going to be a little bit more flexible. We'll go for bone marrow transplantation in multiple myeloma that these patients need to be those patients who respond first of all for treatment there with drugs. In addition, in terms of the transplantation and whether it is localized [ph] in some centers, it depends on the country, I must say that in the state bone-marrow transplantation is doing all over the country also in big centers, as well as in small centers. In Israel, for example, there's more focus more down in specific centers. And again, it depends on the country, but in terms of the U.S. the transplantation are doing in everywhere. The patients are not referred for this treatment.

Yes, I will say, Jason that the latest data, that we have, shows that about 70% or 75% of the transplantations are done at around 50 centers in the U.S. So although the translations are done at many centers, our understanding is that a large majority of them are being done at around 50 major transplantation centers around the U.S.

Thank you. And then -- thanks for taking my questions. And then just one more quick one on AGI, it’s a fairly interesting mechanism of action essentially tagging the cancer cells respond [ph], I’d like to see if you guys could talk a bit more about how this potentially synergizes with checkpoint inhibitors.

Ella, please go ahead, no, no go ahead.

Hi, this is Ella. Thanks Jason for asking the question. So actually based on the mechanism of action it does make sense that it will synergize and they actually have performed in vivo model animal model where we tested a combination of AGI together with checkpoint inhibitor and we were able to show synergies in terms of better scopal effect. I want to point out that this was when we used sub-optimal doses of each of the drugs alone as AGI by itself is optimal dose, had such a good effect that it wasn’t possible to show synergistic effect on top of that. So we used the sub-optimal doses in order to show the synergies and we were able to do so.

All right, thank you very much for taking my questions.

Appreciate. Have a great day, thanks.

The next question is from Joe Pantginis of HC Wainwright. Please go ahead.

Hey, everyone thanks for taking the question. Phil, just curious when we’re looking at the stem cell program going forward assuming it’s successful, just curious if you can add a little more detail or color of the type of work you’ve been doing in the background with regard to the pharmacoeconomic benefits that you mentioned. Like are you looking -- have you done any surveys yet with regard to physicians or looked at the markets yourself, because assuming that would have all the potential benefit from reimbursement discussions as well?

Yes, absolutely. So yes, first of all thanks for joining the call. We have done quite a bit of work in the pharmacoeconomic area and the health outcomes area. We hired a consulting firm before we started the Phase 3 in order to -- from the get go put together and survey all of the and do sort of a map out all of the cost elements that we would need to capture in the Phase 3 study. And so that it could be already included in the protocol as part of the protocol and so we are collecting a ton of information that will help later on build the appropriate model towards the end of the study, which we could then use upon approval for economic justification vis-à-vis payers. So we’re all doing that and like I said it’s not being done on a post talk basis, but this is something that we built in to the study and is running in parallel to the Phase 3.

Great, thanks for the added info.

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

Hey guys thanks for taking the questions. Phil, just one or two for you first on the pending interim readout from BLAST, can you tell us a little bit about what this readout might entail, is this going to be a futility analysis, or are we actually going to see like a portion of the data unblinded what are your expectations for this interim analysis?

Yes, so first -- okay thanks, Mark. So I’ll turn it over to Abi in a second, but I want to say that we’ve been -- I think we’ve also reported this earlier on prior calls and in prior quarters. We have been contemplating and doing an interim analysis now for probably over a year and are trying to ascertain the right amount of events or exposure in the study that would be necessary for us to do the type of interim analysis. Also I might mention that this is in collaboration with a German Leukemia Alliance Group and so therefore all of the decisions here are joint. But -- so we’ve been trying to ascertain the right time that we could do the type of analysis that would be robust enough for us to have a true positive or true negative. And so right now we’re still working both with our statistician, their statistician both sides trying to look at the data what we know of course on a blinded basis. So try to ascertain the right timing for this. And to try to ascertain the number of events necessary to give us a type of power that we could use, for example, to report to investors, use for potential discussions with partners et cetera. So the last thing that we want to do is do it too early and therefore not have the type of robust data that we could use to make important decisions. So that's sort of just the background to the interim analysis. Right now, we believe -- like I said, we believe that we will have enough events to report interim results sometime in the second half of this year. As far as the futility analysis, the type of analysis that we're going to do, it has not yet been decided, but maybe Abi, do you want to add any color to what I've just said?

Actually, you presented very well, I'm not sure that I can say more than you already said. We are following the patient, we're following the right time to do this analysis, we will -- we don't want to do this earlier and to have results that are not showing that what has happened really. And therefore we are -- this is the reason for what we are having the delay, but it's not a delay that -- we believe that is a good delay. But we need to have these events and we are doing continuous analysis in order to have the right time to present the data, and robust data.

I think, the point is as far as futility where something more significant, we still haven't made a decision and it's going to be a joint decision with our collaboration partners. So we still have several months to go before we potentially have to make that decision.

Okay. And so the trial actually been fully enrolled or is it still on current patients?

We haven't really given that data, we -- it's not fully enrolled it's still recruiting, but we haven't provided any data on the number of patients recruited. But this study has been up and running for a two and half or three years. So you can assume that quite a significant number of patients have been recruited already.

Got it. And just a second question on BL-8040 in stem cell mobilization. I'm wondering if you can comment on your plans for potential label expansions beyond the multiple myeloma a target transplant settings. Are you considering adding cohorts to Genesis that might include NHL patients who could be treated with a target transplant? And are you looking at any potential studies involving the BL-8040 as a single agent stem cell mobilizer?

Yes. So, well, let me take the second part first. So as you know, we did a study, a Phase 2 study in allogeneic stem cell mobilization for allergenic bone marrow transplantation as a single agent. We had very nice results similar to the current standard of care. But again, using only one administration of BL-8040 versus multiple administrations of GCSF, for example et cetera. So, if that was very nice data, but our understanding of the market is that the allogeneic market is somewhat more limited, and there's less of an unmet medical need in allogeneic transplantation versus autologous. So we made a decision to move forward with autologous bone marrow transplantation, et cetera. And that's what we're doing right now with the Phase 3. We are definitely considering at some point either us or a potential partner to expand the label. I thought, I think that we felt that the study that would most directly get us to registration and that would be the easiest to recruit would be in multiple myeloma. We certainly would like to expand the label into non-hodg lymphoma maybe into some other types of lymphoma or other I don't know sickle cell anemia or other types of indications. But right now I think our main focus is to push forward and get this product registered with this -- for this particular Phase 3 and in multiple myeloma.

Okay, got it. Thanks for taking questions.

[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 two hours after the conference. In the U.S., please call 1-888-295-2634; in Israel, please call 03-925-5938; Internationally, please call 972-3925-5938. 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 all again for your continued interest in BioLineRx. And we look forward to providing future updates on good things to come. Have a great day.

Thank you. This concludes the BioLineRx fourth quarter 2018 results conference call. Thank you for your participation. You may go ahead and disconnect.