BioLineRx Q1 2023 Earnings Call Transcript

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May 24, 2023

There are 8 speakers on the call.

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First Quarter 2023 Financial Results 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. I would now like to turn over the call to John Lacey, Head of Investor Relations and Corporate Communications, BioLineRx.

Operator

Please go ahead.

Speaker 1

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.

Speaker 1

These include, but are not limited to, the risk factors and other qualifications contained in MylanRx's annual report on Form 20 F, quarterly reports filed in the 6 ks and other reports filed by MyLineRx 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 Phil Serlin, Chief Executive Officer of ByLineRx.

Speaker 2

Thank you, John, and good morning, everyone. Thank you for joining us on our Q1 2023 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 ks. As is our practice, I will begin with an overview.

Speaker 2

Then Mali Zevi, our Chief Financial Officer, will provide a a discussion of our financial results. We will then open the call and are looking forward to your questions. Also joining the call for Q and A are Ella Serrani, our Chief Development Officer Holli May, President of BioLineRx USA and Tommy Rakhmilevich, MD, our Chief Medical Officer. Beginning with our lead program, oticisoportide for stem cell mobilization in patients with multiple myeloma. We announced in November of last year that the FDA accepted our new drug application and assigned a PDUFA target action date of September 9, 2023.

Speaker 2

3. We continue to be on track. In anticipation of potential FDA approval, we have had a very productive quarter across each of our commercial readiness activities, including completing the hiring of an experienced sales force, most of whom have particular expertise in relevant transplant centers across the U. S. We have also substantially advanced supply chain, market access and medical affairs activities.

Speaker 2

We previously talked about our U. S. Leadership, including Holli May, who heads all of our U. S. Activities and has led 14 product launches throughout her career.

Speaker 2

And Kevin Campbell, our new Head of U. S. Sales and Market Development, whose prior experience includes serving as Head of Transplant at Sanofi, where he led a 23 person commercial team, whose portfolio included Plarixafor, known by its brand name Mozaville, for stem cell mobilization. Kevin helped to grow and expand the use of Mozabile and we believe he is the ideal person to help make motixopore type the new standard of care mobilization agent. As we have said several times in the past, but it is worth repeating, based on proprietary market research that we commissioned, the stem cell mobilization market continues to grow and is worth some $360,000,000 in the U.

Speaker 2

S. And more than $500,000,000 globally. With the team that we have assembled, I believe we are very well positioned to capture a significant share of this market over time. Further validating the potential benefits of matixifortide in stem cell mobilization, we were pleased during the quarter to announce the publication of our Genesis Phase 3 clinical trial data, which supports our pending new drug application in the highly regarded peer reviewed journal Nature Medicine. Of particular note, the publication describes how the Genesis trial included patients representative of the current multiple myeloma population undergoing autologous densa mobilization, including older patients and those who received lenalidomide containing induction therapies, both factors associated with impaired mobilization.

Speaker 2

Multiple myeloma is the 2nd most common hematologic malignancy and stem cell transplantation has been shown to improve survival and as such plays a central role in the treatment of these patients. A meaningful number of patients, however, are unable to collect the target number of peripheral blood CD34 positive hematopoietic stem and progenitor cells with the current standard of care in stem cell mobilization. The primary objective of the study was to demonstrate that one dose of metixifortide with G CSF compared to placebo with G CSF allowed more patients to mobilize 6,000,000 CD34 positive cells or more per kilogram of body weight in up to 2 apheresis sessions. A secondary objective of the study was to demonstrate that one dose of metixoportide with G CSF was superior to placebo with G CSF and its ability to mobilize 6,000,000 CD34 positive cells or more per kilogram of body weight in just one apheresia session. The clinical trial found that all primary and secondary endpoints were achieved with statistical significance p value of less than 0.0001.

Speaker 2

If approved, matixiportide would be the first true advancement in stem cell mobilization in over a decade. In parallel with our development work in stem cell mobilization for multiple myeloma, we believe there are additional therapeutic areas where the demonstrated benefits of matixoportide can be beneficial. One of these is autologous hematopoietic stem cell based gene therapy for patients suffering from sickle cell disease, one of the most common genetic diseases globally. To that end, in March, we announced a clinical trial collaboration with Washington University School of Medicine to evaluate metixaforzite in this indication. Unlike multiple myeloma patients, one of the current standard of care mobilization agents, GCSF, carries significant risks and potential severe side effects for patients suffering from sickle cell disease.

Speaker 2

Furthermore, in many cases, the other current mobilization treatments failed to reliably yield optimal numbers of stem cells to facilitate gene therapy. As such, this patient population is in urgent need of an effective new mobilization regimen. Through this collaboration, we plan to conduct a proof of concept trial that will study matixifortide as both a single agent and in combination with the immunomodulator natalizumab. This study will assess the safety and tolerability of the 2 regimens as mobilization agents of CD34 positive hematopoietic stem cells in patients with sickle cell disease and is anticipated to begin enrollment in the second half of twenty twenty three. Let's turn now to our clinical programs in metastatic pancreatic cancer.

Speaker 2

Recall that metixoportide is being evaluated in an investigator initiated metastatic pancreatic cancer trial in collaboration with Columbia University. This Phase 2 study is evaluating oncixoportide in combination with the anti PD-one samiplimab and standard of care chemotherapy in first line metastatic pancreatic cancer patients. This study continues to progress and we anticipate data from the 1st cohort of patients this year. We also previously announced a collaboration with Gensleep Therapeutics, pursuant to which Gensleep will execute a rigorously designed randomized Phase 2b clinical study assessing matixa-four ten in combination with a PD-one inhibitor and standard of care chemotherapy in approximately 200 first line metastatic pancreatic cancer patients in China. This collaboration follows the positive results that we reported from our Phase 2a COMBATKEYNOTE-two zero two triple combination study of latixitifortide in combination with the ANGI PD-one pembrolizumab and chemotherapy in second lung patients.

Speaker 2

As a reminder, data from that Phase 2a study demonstrated a 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. We anticipate that the GenFLETE Phase IIb trial will initiate by the end of this year. Turning now to our second clinical candidate, the investigational intratumoral anticancer vaccine AGI-one hundred and thirty four. We believe AGI-one hundred and thirty four coach tumor cells with alpha gal to make them look like foreign tissue in order to evoke an immune response that both destroys existing tumors and also provides a vaccine like effect. In December, we announced results from a Phase IIIa study in AGI-one hundred and thirty four in metastatic solid tumors.

Speaker 2

The first in human single agent study met its primary endpoint for safety and tolerability and demonstrated immune activity across multiple biomarkers. At this time, we are evaluating potential development program pathways in consultation with the program's Scientific Advisory Board, and we will provide further updates as appropriate. I would now like to turn the call over to Mali Zevi, our CFO, who will give a brief overview of our main financial results. Molly, please go ahead.

Speaker 3

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 6 ks filing we made this morning, which contains our financials and press release. Research and development expenses for the 3 months ended March 31, 2023, were $3,700,000 a decrease of $700,000 or 16.9 percent compared to $4,400,000 for the 3 months ended March 31, 2022. The decrease resulted primarily from lower expenses related to NDA supporting activities related to motixophotide as well as lower expenses associated with the completed AGI-one hundred and thirty four clinical trial.

Speaker 3

Turning to cash, the company held $43,300,000 of cash, cash equivalents and short term bank deposits as of March 31, 2023. This does not include $30,000,000 available to us under the debt agreement with Crius Capital, which is tied to the attainment of certain milestones. We believe we are well financed to fund our operations and as currently planned into the first half of twenty twenty four. And with that, I'll turn the call back over to Phil.

Speaker 2

Thank you, Mollie. In closing, as is our customer, I would like to take a few moments to summarize our key upcoming milestones. 1st, potential FDA approval of AFFXTA this coming September potential U. S. Launch of AFFXTA shortly after approval initiation of a clinical trial in collaboration with Washington University School of Medicine to evaluate matixifortide as monotherapy and in combination for CD34 positive hematopoietic stem cell mobilization for gene therapies in sickle cell disease, which is expected to begin in the second half of twenty twenty three of this year.

Speaker 2

Initiation of a Phase 2b randomized clinical trial with 200 patients assessing the tixitifortide in combination with a PD-one inhibitor and standard of care chemotherapy as a first line metastatic pancreatic cancer therapy with collaboration partner Gensley also by the end of this year. And finally, initial cohort data for the ongoing Columbia University investigator initiated study evaluating motixafortide in combination with PD-one inhibitors, samiplimab, and standard of care chemotherapy in first line metastatic patients with pancreatic cancer also in the second half of this year. With that, we have now concluded the formal part of our presentation. Operator,

Speaker 4

we will now open

Speaker 2

up the call to questions.

Operator

Thank you. Ladies and gentlemen, at this time, we will begin the question and answer The first question is from Joe Pantginis of H. C. Wainwright. Please go ahead.

Speaker 4

Hey, everybody. Good morning and good afternoon. Thanks for taking the question and continued good luck wishes ahead of the PDUFA date. So a couple of questions, Phil. First, as you're preparing for potential approval, I guess one of the things I wanted to see get more color on how have you're, I guess let's call it pre discussions with payers been going on?

Speaker 2

Yes. So first of all, good morning, Joe. Thanks for joining the call. Let me turn that question over to Holly. She can provide a little color on that.

Speaker 5

So I think Joe, for the next June. So I would say going quite well. We have, I think, I think the last time we spoke, solidified more of our market access plan. And that includes the bulk complement of national account representatives, executives in the field being able to really understand the marketplace and understand where the payers are. Obviously, we aren't talking anything at this point in time because of the Raylan product, but we are we do have a very experienced national account executive team that is really starting to understand what we need to be successful around market access in the marketplace.

Speaker 5

We also are engaging with external stakeholders. As time goes on, we will be having a steering committee to help to continue to advise us in the future.

Speaker 4

Got it. No, that's helpful. Thank you. And then I guess I'll just stick with matricotori for just a second here. And of course, it's my obligatory question on sort of status of BD discussion, but I'll approach it this way today in the sense that it's a bit of a hybrid approach here where going into September you might have an approved drug for a particular therapeutic approach.

Speaker 4

And then of course you have the long standing oncology approach as well. So how do you think that impacts your potential BD discussions going forward? And if you just focus on the oncology standpoint, do you think it might fit into the category of or longstanding category of a partner would be interested once they see the randomized Phase 2b data? Thanks a lot.

Speaker 2

Yes. So I mean we've had that approach for quite a while. So I mean we are fully focused right now on the commercialization of stem cell mobilization, the self commercialization in the U. S. And we're moving forward on that as Holli mentioned.

Speaker 2

And as we've disclosed in our public filings. Of course, we do have the PDAC and then oncology, the solid tumor area that we're developing. And our idea is with the randomized data, both from the study that we're doing in collaboration in China as well as the data that we have and that we're that is being produced in the Columbia University collaboration, we're hoping the 2 together would provide us with the type of data that we would be able to initiate discussions with a potential partner with. And so that's sort of what we're doing and I think that we haven't veered from that approach for several quarters already.

Speaker 4

No, I appreciate that. Thanks. And if you would just indulge me a little bit of a shift question on 134. Obviously, things are developing. You're very resource focused on matixitore type.

Speaker 4

But any potential broad strokes you can take with regard to the design of next steps?

Speaker 2

Yes. So let me turn that over to Ella. Ella, you want to take that question?

Speaker 6

Yes, sure. Hi, George. This is Ella. So with regards to API, we are currently assessing the development for going forward. We're discussing with our scientific advisory group.

Speaker 6

And I cannot be too much go into too much specifics. However, it's probably fair to say that going forward we will probably continue to do a combination study.

Operator

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

Speaker 7

Hey, guys. Congrats on the progress this quarter and thanks for taking our questions. Just a couple of quick ones from me. First, just with respect to the upcoming expiry date of the Genzyme Sanofi patents on paroxaport. How quickly after that expiration do you expect generics to enter the U.

Speaker 7

S. Market? Is it kind of going to be an immediate thing? Or is it maybe we'll see a little bit of a lag or gap before generics are approved here? And then the second question, just I think Mali was clear with regard to the financial guidance, and cash runway guidance, but operational runway extending into the first half of twenty twenty four, that is exclusive of the $30,000,000 in debt tranches from CREOS.

Speaker 7

Is that correct? Thanks for taking the questions.

Speaker 2

Okay. So first of all, good morning and thanks for joining the call. I'll take the second question. And then the first part of the question, I'll hand over to Holli. Regarding our financial resources, our guidance does not take into account the $30,000,000 of the framework of the Kreos loan.

Speaker 2

Okay, so that's with regard to your second part of your question. Regarding generics, I will just say overall the exclusivity runs out at the end of July for plarixa-four. I think we do expect a couple of generics. There are some ANDAs that have filed. And so we do expect a couple of generics, but it's really hard to say.

Speaker 2

I think maybe Holli can provide a little more color on that. Go ahead, Holli.

Speaker 5

Okay. I would just say basically that I mean, in some ways it's anyone's guess as to what the generic manufacturers are going to do. That said, we have for our research, we've not uncovered anything that would say they are not coming to market. I know this is a little bit of a different situation just because Sanofi Genzyme did defend their patent. So it's kind of a long a longer time to market for these manufacturers.

Speaker 5

So we are keeping a key eye on it. This is all part of our ongoing market research is to have some sort of intelligence around marketplace and landscape and we are taking that into consideration. That said, our DSOB research really suggests that the petroside is well positioned to take a significant share of the market over time despite generic competitors to the 1st generation mobilizer that's currently in the marketplace. So we are still we still have great confidence.

Speaker 2

Yes. I mean, I'd like just to add to that. I mean, it's very important for I think that we've emphasized that we believe that we are highly differentiated from cilarexophore and obviously any generics that are coming in once the low loss of exclusivity happens. And so therefore, we believe that obviously it may affect us, but we think that we are still moving forward and are confident that we can, as as Holly said, take a significant share of the market.

Speaker 5

And I think Phil and our tag team have this answer. Just to add on what Phil said, yes, well positioned, our research has shown both on the clinical side as well as on the value and economic side of the value

Operator

The next question is from John Van der Moulsen of Zacks. Please go ahead.

Speaker 7

Thank you and hello everyone. Phil, you've mentioned the $500,000,000 global market for Bexta. And what are the trends outside the U. S. For growth and the structure of the market?

Speaker 7

Is it similar to the U. S. Where there are few sites responsible for most of the procedures or is it or does it have a different structure?

Speaker 2

I think the overall there are certain there are large transplantation centers that are handling transplantations both in the U. S. And also around the world. But of course, I think that we've mentioned in Europe, the pricing is different, the regulation is different, the payer is different, the payer the way reimbursement happens is different in certain areas, the standard of care is different than the U. S.

Speaker 2

So there are a lot of there are question marks regarding the rest of the world and obviously we're focusing right now on the U. S. Because that's the key market and that's where we're initiating our commercialization steps. And I think that we've said this several times in the past, once we get approval and launch, we will certainly look to maximize the value outside of the U. S.

Speaker 7

Okay. And as you look here, are there I'll check if I what's the 4 type programs as the 2 PDEC programs and the cell gene therapy program, how do you look at those in terms of opportunity? I mean, you've got some geographical expansion partners there. What do you see when you see those in terms of opportunities and how do you rank them? Yes.

Speaker 7

So I mean,

Speaker 2

both in the study that both in the study that's going to be initiating in China as well as the one that's happening at Columbia University. We believe that the next steps would be something much more significant, much more global. And that's obviously not only in pancreatic cancer. We think that if it works in pancreatic cancer, it's likely to work in several other indications. And so we look at it as a huge potential market.

Speaker 2

Of course, pancreatic cancer is a difficult indication and it's a high risk indication, but also very, very high reward. So I think that would be obviously if we do see the results that we're hoping to see that could be obviously a very, very significant opportunity for us. In gene therapy, I think that's also something that we look at as a high potential. There are a lot of there are new therapies that are being developed that we hope that there are going to be several gene therapies in the next 18 to 24 months that will receive approval. We think they all require a substantial number of cells and we believe that we are very well positioned to move into that market because of the what we believe to be we believe that we are a highly differentiated and very robust mobilization agent.

Speaker 2

So we think that that will also be a key area of growth for us in the future.

Speaker 7

Okay, great. Yes, lots of opportunities for that. And last one for me on the Nxion manufacturing and CMC side. I guess those efforts are progressing as expected and there will be sufficient quantities. And I believe you have those arrangements with Biokine.

Speaker 7

I think that's still current. Do you look for perhaps another partner as you expand further perhaps geographically to have another manufacturer to support global operations?

Speaker 2

Yes. So BioKine is the licensor for 416 of 4 type, but they are not the manufacturer. They're just simply they were the original licensor to us of the product. Our manufacturers are larger, well established manufacturers for the API in the U. S.

Speaker 2

And for the drug product in Europe. And we don't see any problems meeting our current demand over the next number of years. So that really isn't an issue from our perspective at this point.

Speaker 7

Okay, great. Thank you, Phil. Appreciate it.

Speaker 2

All right. Thanks, John. Have a great day.

Operator

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-eight eighty eight-two ninety five-two thousand six hundred and thirty four.

Operator

In Israel, please call 3,925,9004. Internationally, please call 9,723, 925-5904. Mr. Serlin, would you like to make your concluding statement?

Speaker 2

Yes, thank you. Thank you, operator. In closing, we are progressing through 2023 with significant momentum. We are preparing for the potential U. S.

Speaker 2

Approval of our first therapy in stem cell mobilization and our commercial organization is readying for a robust launch with a highly experienced team. We have initiated a new program in an additional and important transplant area by entering into collaboration to execute a clinical trial with motixoportide as a mobilization agent in gene therapies. We are also making notable progress in our pancreatic cancer program and anticipate important data from a first line investigator initiated study later this year as well as the initiation of our GENTI collaboration study. I am very pleased with our progress during the Q1 and I'm very excited about what we are in the process of achieving this year. Thank you all very much for your continued interest in BioLineRx and we look forward to providing our next comprehensive update in August.

Speaker 2

Be safe and have a great day. Thank you.

Operator

Thank you. This concludes the BioLineRx Q1 2023 conference call. Thank you for your participation. You may go ahead and disconnect.

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Key Takeaways

  • PDUFA target date for motixafortide (AFFXTA) in stem cell mobilization set for September 9, 2023, with U.S. commercial readiness activities well advanced, including hiring an experienced sales force.
  • Genesis Phase 3 trial data supporting the NDA were published in Nature Medicine, showing statistically significant improvement in CD34+ cell mobilization even in older patients and those treated with lenalidomide.
  • An investigator-initiated autologous stem cell gene therapy trial in sickle cell disease is set to begin in H2 2023 with Washington University to assess motixafortide’s safety and efficacy as a mobilization agent.
  • Ongoing and planned metastatic pancreatic cancer studies include a Phase 2 Columbia University trial of motixafortide plus PD-1 inhibitor and chemotherapy, with data expected this year, and a randomized Phase 2b trial in China targeting initiation by year-end.
  • As of March 31, 2023, BioLineRx held $43.3 million in cash and equivalents (excluding $30 million in potential debt), providing funding into the first half of 2024.
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Earnings Conference Call
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