BioLineRx Q4 2023 Earnings Call Transcript

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Provided by Quartr
March 26, 2024

There are 7 speakers on the call.

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx 4th Quarter and Full Year 2023 Financial Results Conference Call. All participants are presently in a listen only mode. Following management's formal I would now like to turn over the call to John Lacey, Head of Investor Relations and Corporate Communications. John, please go ahead.

Speaker 1

Thank you, operator. Welcome, everyone. Thank you for joining us on our Q4 and full year 2023 results conference call. Earlier today, we issued a press release, a copy of which is available in the Investor Relations section of our website. It was also filed in the 6 ks.

Speaker 1

I'd like to remind you that certain statements we make during the call will be forward looking. The such statements deal with future events and are subject to many risks and uncertainties. Actual results may differ materially from those in the forward looking statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 20 F and our quarterly reports on Form 6 ks that are filed with the U. S.

Speaker 1

Securities and Exchange Commission. At this time, it is now my pleasure to turn the call over to Mr. Phil Turland, Chief Executive Officer of BioLine RA.

Speaker 2

Thank you, John, and good morning, everyone, and thank you for joining us on today's call. Joining me today are Holli May, President of BioLineRx USA and Mali Zevi, our Chief Financial Officer. In addition, Ella Serrani, our Chief Development Officer will be joining the call for Q and A. I will begin with a brief update on our Efexda launch, then turn the call over to Holli who will go into the stem cell mobilization opportunity in more detail. I will then provide an update on our clinical programs in pancreatic cancer and sickle cell disease.

Speaker 2

Finally, Molly will provide a discussion of our financial results. We will then open up the call and are looking forward to your questions. Following the launch of our product in stem cell mobilization just a few months ago in Q4, we expect substantially all of 2024 to continue to be a foundational period for the commercialization of AFFXTA, the first advancement in stem cell mobilization in over a decade. Since FDA approval in September and the subsequent launch of Effexa in the U. S.

Speaker 2

In Q4, early signs among payers in top tier stem cell transplant centers suggest that the AFFXA value proposition is resonating very well and evolving the stem cell mobilization treatment paradigm for patients with multiple myeloma. Recall that a key consideration when we elected to commercialize AFFXTA independently in the U. S. Was that end users of AFFXTA Transplant Centers are well defined with approximately 80 of the 212 Transplant Centers performing the vast majority, approximately 85% of all procedures. Among this defined population, we have already secured formulary placement within these top 80 transplant centers, managing approximately 20% of all stem cell transplant procedures at these institutions.

Speaker 2

Those familiar with commercial launches know that institutional pharmacy and therapeutic committees or PNTs determine formulary status, the first step in center adoption and we anticipate that by year end we will have secured formulary placement within these top 80 transplant centers, managing approximately 60% of all stem cell transplant procedures at these institutions. We are pleased with this progress and momentum, which is right in line with our expectations. Our customer facing teams have done a fantastic job working with centers to support them in developing protocols following PNT approvals, and we are very pleased by the number of clinical champions we are gaining every day. We have also received several repeat orders from multiple institutions. These centers were early adopters and moved quickly through the formulary process and subsequent design and adoption of new treatment protocols.

Speaker 2

Importantly, one highly regarded transplant center has already transitioned all of its patients to Effexxa as it recognizes the value of greater apheresis certainty. We are pleased by this early momentum despite the fact that some customers have benefited from lower acquisition costs for generic mozabil or florixa florixa-four relative to reimbursement rates. This cost recovery advantage has been diminishing with time as reimbursement rates adjust to having generic florixa-four in the landscape. Meanwhile, transplantation centers are gaining the including the overall economic benefit of reducing apheresis days and the predictability regarding the number of apheresis days and the impact this reduction has on patients as well as nursing and technical staffing for apheresis, particularly in today's difficult hiring environment and the competition for apheresis chair time. Staying on the topic of stem cell mobilization, recall that in October we closed an exclusive agreement with Gloria Biosciences for the development and commercialization of matixafortide across all indications in Asia.

Speaker 2

In order to receive market authorization for Effexa in China, a small bridging study is required. I'm pleased to share that the IND for this bridging study was filed in February with the Center For Drug Evaluation of the National Medical Products Administration and we anticipate regulatory action in May. First patient dosed in this study is expected in the second half of this year. Additionally, for countries in Asia that do not require a bridging study, Gloria is making great progress. We anticipate commercialization to begin in the Abao region of China, in Singapore and in Macau over the next few quarters.

Speaker 2

We believe that commercialization in these territories will provide non U. S. Revenue in the second half of the year or early next year, subject to regulatory approval. We estimate that Asia had over 51,000 reported cases of multiple myeloma, the largest number of cases globally and stem cell mobilization for autologous transplantation represents a significant opportunity for both companies in the region. Needless to say, we are very pleased with how our Gloria collaboration is progressing.

Speaker 2

We are also pleased by the progress that we have made since our last quarterly update on our other matixa fortnight programs, notably pancreatic cancer and sickle cell disease. I will provide updates on those programs in a moment. But at this point, I'd like to turn the call over to Holli May, President of BioLineRx US for a more detailed review of our early launch progress. Holli, please go ahead.

Speaker 3

Thank you, Phil. As Phil indicated, patients, physicians and transplant center teams have begun experiencing strong stem cell mobilization results with Effexa. We call this the A plus apheresis experience. Importantly, each positive experience resonates within institutions already using AFFXA and supports strong peer to peer conversations between physicians at other institutions. As Phil said earlier, last quarter and this full year is foundational for AFFXTA commercialization.

Speaker 3

The pathway to adoption of any new drug of this type is roughly the same P and C committee scheduling and review, institutional protocol development and staff training, 1st patient scheduled and use, experience assessment, reorder. This cycle will happen across our top 80 centers and is occurring at a pace that we anticipated. We have a very strong value proposition for patients, transplant centers and payers, and it is resonating. Our goal is to significantly reduce patient and caregiver burden by providing increased assurance in individual apheresis journeys. Additionally, for transplant centers with significant apheresis volume, we can show the advantages that AFFEXTA provides for scheduling and use of chair time.

Speaker 3

Remember that patients with multiple myeloma in the United States are now often treated with quadruple induction therapy, which includes lenalidomide and verituzumab. Quad therapy leads to the highest rate of complete responses and prolonged progression free survival. However, this combination is known to contribute to poor stem cell mobilization collection experiences, which leads to an increase in the amount of atrial successions needed to collect the targeted number of CD34 positive stem cells required by institutional protocols. With treatment for multiple myeloma moving to quad therapy, we believe this further strengthens our value proposition. Our targeted field force, which was hired based on their significant and relevant experience, is educating transplant center and HRE's leadership teams on the benefits of Effexa.

Speaker 3

Physician reactions from our meetings at ASH 2023 and more recently at Tandem 2024 have demonstrated a strong belief in our clinical data. Our poster sessions at both conferences further bolstered our clinical story. Since launch, we have successfully made in person contact with all top tier centers. Overall, we estimate the top 80 transplant centers in the U. S.

Speaker 3

Manage approximately 85% of all transplants annually. To date, we have been granted formulary approvals by institutions which manage approximately 20% of all stem cell transplant procedures within these institutions. By the end of quarter 2, we anticipate that this will increase to approximately 35% of transplant procedures at these top 80 centers. And as stated, by the end of the year, we anticipate formulary status and both managing 60% of the transplants in these centers. Now regarding the entrance of generic multiple for chloroxifor into the market.

Speaker 3

As we've said, while we consider chloroxifor to be the same overall market as AFFXTA, we do not see the generic Plurixa-four as comparable to our drug. AFFXTA is a 2nd generation CXCR4 inhibitor and has a highly differentiated product profile based on stronger and more predictable mobilization outcomes. Furthermore, our early discussions have shown that centers appreciate the innovation as they look to address their needs for a better mobilizer. Turning now to payers. Payers view the effects of clinical data very favorably and as a result, we have to date established access for 95% of covered lives across a mix of both commercial and government payers.

Speaker 3

We continue to work to increase this number so that defexip is as broadly accessible to patients as possible. Additionally, the Centers For Medicare and Medicaid Services issued us a unique J code for Effexa, which is critical for obtaining timely reimbursement from all commercial and government payers. Another way we provide reimbursement covenants is through BioLineRx Connect, our provider and patient services hub. Through this hub, providers can enroll patients to obtain assistance and benefits verification from prior authorization. If coverage issues arise, the hub can step in and help resolve issues.

Speaker 3

Additionally, payers can enroll their patients in the patient assistance program if they cannot afford the cost of Effexa. Those who qualify can receive drugs at no cost. In summary, I'm very pleased with our launch progress to date. Our commercial and medical affairs teams are generating results in the early stages of this launch as we continue to engage with top transplant centers, physician leaders and payers on this exciting new treatment option. Now let me turn the call back over to Phil.

Speaker 2

Thank you, Holly. Turning now to our 2nd development indication for matixiportide pancreatic cancer. Remember that matixiportide has been shown to leverage the expression of CXCR4 on different immune cells and can increase the effectiveness of immune system treatments for solid tumors. CXCR4 is highly expressed in over 20 solid tumor types and correlates with poor patient prognosis. In studies with PD-one inhibitors and chemotherapy in pancreatic cancer, PD-one inhibitors, a major background of immune importantly in an 80 patient Phase 2 study with 2 cohorts that we completed a few years ago, we demonstrated that motixiportide is synergistic with PD-one inhibitors in the treatment of pancreatic cancer.

Speaker 2

This Phase 2 study showed proof of mechanism of the synergistic effect with PD-one in multiple late stage treatment lines as well as promising efficacy when metixifortide is combined with both a PD-one inhibitor and chemotherapy in second line pancreatic cancer patients. Based on this promising data, we entered into a Phase 2 study collaboration in first line pancreatic cancer sponsored by Columbia University and supported equally by BioLineRx and Regeneron. Recall that the trial known as chemo for metpanc originally had an initial pilot phase and based on the results of this pilot phase an assessment would be made on advancing to an expansion phase of the study. As we presented at the AACR Special Conference on pancreatic cancer last September, the data in the pilot phase of the study was quite compelling. 7 of 11 patients or 64% experienced a partial response, of which 5 were confirmed PRs as of the July 2023 cutoff date with 1 patient experiencing complete resolution of the metastatic lesion in the liver.

Speaker 2

Along with the 3 patients with 27% experiencing stable disease, this resulted in a disease control rate of 91%. These findings compare favorably to historic partial response and disease control rates of 23% 48% respectively reported with the current standard of care. Based on these compelling data, the collaboration partners in this study Columbia, Regeneron and BioLineRx agreed to amend the original expansion phase of the study from a single arm expansion study with a target enrollment of 30 patients to a much larger randomized Phase 2b study of 108 patients with 2 arms, metixoportide, the PD-one inhibitor cemiplimab and standard of care chemotherapy versus standard of care chemotherapy alone. The trial's primary endpoint is progression free survival. Secondary objectives include safety, response rates, disease control rate, duration of clinical benefit and overall survival.

Speaker 2

And last month, we announced that the first patient was dosed in this randomized Phase 2b study. We believe the combination potential of matixiforta and PD-one inhibitors in pancreatic cancer and other solid tumors could be a significant multibillion dollar opportunity and our work in pancreatic cancer, one of the most difficult to treat cancers is the starting point. Also in pancreatic cancer, a license agreement with Gloria Biosciences covers pancreatic cancer as well and we are working with them on the design of a randomized Phase 2b clinical trial evaluating matixiportet in combination with GLORIA's commercially approved PD-one inhibitor zembrolumab and standard of care combination chemotherapy in first line pancreatic cancer. Zembrolumab is approved in the Asia region for relapsed or refractory classical Hodgkin's lymphoma and for recurrent or metastatic cervical cancer. Gloria Biosciences went from IND to commercialization of zimberilumab and its first indication in China within 4 years.

Speaker 2

So we believe they are uniquely positioned to explore the potential utility of in the first half of twenty twenty five. We are also evaluating matixoportide as a mobilization agent in autologous hematopoietic stem cell based gene therapy patients suffering from sickle cell disease, one of the most common genetic diseases globally. Hematopoietic stem cell transplantation after genetic modification is potentially cured for patients with sickle cell disease. However, significant quantities of hematopoietic stem cells are required for genetic manipulation and transplant success and the most commonly used drug for collection of stem cells, G CSF, is contraindicated in patients with sickle cell disease. Therefore, peripheral blood mobilization of stem cells using Plurixa 4 is the current strategy to collect hematopoietic stem cells for sickle cell disease gene therapies.

Speaker 2

As with multiple myeloma patients, in many cases, the current mobilization treatment fails to reliably yield optimal numbers of stem cells and sickle cell disease patients often require 2 to 4 mobilization cycles with each cycle including 2 or more apheresia sessions with a minimum 14 day washout period between each cycle to collect an adequate number. As such, this patient population is very much in need of an effective new mobilization regimen. To that end, last March, we announced the clinical trial collaboration with Washington University School of Medicine in St. Louis to evaluate matixifortide in this indication. Together with WashU, we are conducting a proof of concept trial to study matixifortide as both a single agent and in combination with the immunomodulator natalizumab.

Speaker 2

The study is evaluating the safety and tolerability of 2 regimens as mobilization agents of CD34 positive hematopoietic stem cells in patients with sickle cell disease as well as efficacy endpoints. Sickle cell disease is an important lifecycle strategy for AFFXTA and we are in discussions with multiple stakeholders to understand its potential usage in patients who may qualify for the 2 recently approved gene therapies in the United States. We were very pleased to have to dose the first patient in this important trial in December and we anticipate data in the second half of this year. In summary, we are very excited by both our pancreatic cancer and sickle cell disease clinical development programs, which may provide incredible value and shareholders. At this point, I'd now like to turn the call over to Mollie, who will review our financials.

Speaker 2

Mollie, please go ahead.

Speaker 4

Thank you, Phil. As is our practice, in our financial discussion on this call, we will go over the most significant items in our financial statements: revenues, sales and marketing expenses, research and development expenses, non operating expenses, net loss and cash. I invite you to review the filings we made this morning that contain our financial 20 F and press release for additional information. Total revenues for the year ended December 31, 2023, were $4,800,000 compared to no revenues for the year ended December 31, 2022. Revenues in 2023, all of which were recorded in the 4th quarter, primarily reflect a portion of the upfront payment from the Gloria Biosciences license agreement, of which $4,600,000 was recorded in 2023 as well as $200,000 of revenues from product sales of AFFXTA in the U.

Speaker 4

S. Cost of revenues for the year ended December 31, 2023 amounted to $3,700,000 compared to no cost of revenues for the year ended December 31, 2022. The cost of revenues in 2023, all of which was recorded in the Q4, primarily reflect a $3,000,000 sublicense fee to the upstream licensor of Onpixa Fortis payable on closing of the exclusive license agreement in Asia as well as amortization of an intangible asset in respect of this license revenues in the amount of $500,000 Cost of product sales were insignificant, representing approximately 6% of related sales. Research and development expenses for the year ended December 31, 2023, were $12,500,000 as compared to $17,600,000 for the year ended December 31, 2022. The decrease resulted primarily from lower expenses related to motixaforat NDA supporting activities as well as lower expenses associated with completion of the AGI-one hundred and thirty four study.

Speaker 4

Sales and marketing expenses for the year ended December 31, 2023 were $25,300,000 as compared to $6,500,000 for the year ended December 31, 2022. The increase resulted primarily from the ramp up of pre commercialization and commercialization activities related to forte. Non operating expenses for the year ended December 31, 2023 were $10,800,000 compared to non operating income of $5,700,000 for the year ended December 31, 2022. Non operating expenses and income primarily relate to the non cash revaluation of outstanding warrants resulting from changes in the company's share price during the respective periods. Net loss for the year ended December 31, 2023 was $60,600,000 compared to $25,000,000 for the year ended December 31, 2022.

Speaker 4

The net loss for 2023 included $17,800,000 of non cash expenses, specifically an expense of $11,100,000 for the revaluation of warrants and a one time $6,700,000 impairment of intangible assets associated with discontinuation of the AGI-one hundred and thirty four development program. The net loss for 2022 included $6,400,000 of non cash income, specifically related to the reevaluation of warrants. As of December 31, 2023, the company had cash, cash equivalents and short term bank deposits of $43,000,000 The company anticipates that this amount and other available resources, including amounts available under a debt facility with Curis Capital, will be sufficient to fund operations as currently planned into 2025. And with that, I'll turn the call back over to Phil.

Speaker 2

Thank you, Mollie. In closing, as is our custom, I would like take a few moments to summarize our key upcoming milestones. 1st, continued commercial ramp up of Effexa in the U. S. Next, commercial expansion in Asia with collaboration partner Gloria Biosciences.

Speaker 2

Then initiation of bridging study by Gloria Biosciences in 2024 to support approval of Effexa in stem cell mobilization for multiple myeloma in China. Next is completion of recruitment in the Phase 1 pilot study of metixifortide for hematopoietic stem cell mobilization for gene therapies in sickle cell disease led by Washington University School of Medicine with initial data expected in the second half of this year. Next is continued recruitment in the chemo for medpanc Phase 2 randomized clinical trial in first line metastatic pancreatic cancer sponsored by Columbia University. And lastly, preparation activities with Gloria Biosciences on a randomized Phase 2 clinical trial evaluating metixifortide in combination with the PD-one inhibitors imberilumab and standard of care chemotherapy in first line pancreatic cancer. With that, we have now concluded the formal part of our presentation.

Speaker 2

Operator, we will now open 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 John Vandermosten of Zacks. Please go ahead.

Speaker 1

Good morning, Phil and everyone else, and thanks for taking my questions. Let me start out with the just to get a little bit better understanding about how the formularies work. And when a text is added to the formulary, is it immediately replacing third support and other alternatives? Or is there it sounds like there's some education that's required to get to get on board with it, is that correct?

Speaker 2

John, so I just want to make sure, I guess the line isn't that clear. I want to make sure I understand, first of all, good morning. And Samuel, I think are you asking about the formulary process, how it works and how long the process takes? Is that did I understand correctly?

Speaker 5

Yes. And also, are the teams immediately picking up the use of OpExda or is there some education required to get them to get on board with it?

Speaker 2

Okay. Thanks very much. Holly, would you like to take that?

Speaker 3

Yes. That would be great. Good morning, John. Thanks for the question. So you're right.

Speaker 3

With this type of a product, formulary acceptance is critically important. It behaves while this is an outpatient product, it is sold in transplant centers associated with hospital institutions and therefore does require a P and T approval. So the way that it works is that, I mean, this is work. This is work and that's exactly why we put the 3 field teams in place, sales, medical, as well as the payer team. And what's required is always having a clinical champion, an MD clinical champion, and then making sure that the message gets out to those who are associated with making the decision.

Speaker 3

And then you need to get on the schedule for formulary for the P and T committees. This can take several months. And then once the decision is made, the formulary decision is made, then protocols need to be in place, order sets then need to go in place. So that takes some time. Some institutions have PMT meetings monthly, some are every other month.

Speaker 3

These are things that the field team knows and understands, and we are working critically hard on getting on those formularies. So once on, yes, we have gotten several acceptances and we are very happy to be selling Effexka in many institutions. It's really very much up to the institution as to what those protocols look like and whether it's kind of sole formulary or if it's a shared formulary. I will say that we have had some institutions which have made the full switch over to AFFXTA for multiple myeloma. But I do want to make sure that I've answered your question clearly and that everyone understands that this cycle does take some time and therefore the uptake ramp for FX that is exactly as we were expecting.

Speaker 3

It's a little bit of a slower uptake than something such as like a retail product, etcetera. Now does that answer the question? Yes.

Speaker 5

Thank you, Holly. That does. And then kind of continuing on from there, it sounds like there is somewhat of a standardized process to getting on the formulary. But is there a big level of difference in difficulty? I mean, maybe there's a lot more hoops you have to jump through for some formularies rather than others.

Speaker 5

Is it pretty similar or some a lot harder?

Speaker 3

Yes. Okay. Well, we have a saying that if you've seen one transplant center, you've seen one transplant center. So certainly there are ranges of ease or difficulty by center. So it's not that standard.

Speaker 3

Getting to know who the decision makers are is always the first challenge and then being able to get to those individuals is important. You did ask a question that I part of the question initially that I don't think I answered. It is really, really important that there is either during and then after the formulary decision that education and in servicing, we call it in servicing with the institutions, is in place so that, everyone knows how to dose the product, everybody knows how to administer and have best patient care. So it is definitely a process and it differs most certainly by institutions. Some are quicker and some have a little bit more of a prolonged formulary process.

Speaker 3

So we the field teams understand these differences, and then they work center by center on what is required.

Speaker 1

Okay, great. Yes, thank you for the thorough description

Speaker 5

of how that works. And second question is on the gene therapy opportunities. I think you suggested that

Speaker 1

the 2 approved sickle cell gene therapy,

Speaker 5

I think it's Kastegbe and Lithunia, are being used in that in the Washington University study. Have you been contacted by other gene therapies to possibly look at other uses of matixifortide in gene therapy processes?

Speaker 2

Yes. So first of all, John, I think there might be a mistake, I don't know, or a misunderstanding because we are doing a Phase 1 trial for mobilization of sickle cell patients at WashU, but these are not patients that are receiving any gene therapy, neither Vertex is nor Bluebirds at this point. So I just wanted to make sure that you understand that and if there was a misunderstanding, I apologize. So how but we are I mean, I just I can say that we are speaking with companies and with institutions, etcetera, etcetera. This is an area of real interest to us.

Speaker 2

I mean, we see this as a huge potential upside for the company. These patients require huge amounts of cells, 15,000,000 to 20,000,000 hematopoietic cells per kilogram and have very a lot of difficulty mobilizing, especially since they can't get G CSF. So we think that we have a great product for them and we're very much looking forward to getting the safety data and some initial efficacy data so that we can continue to make noise in this area and enter into other collaborations on the way towards being able to sell the product.

Speaker 6

Can I

Speaker 3

add on to that? I just want to be clear about the opportunity. This would be for ex vivo type of approaches or those approaches, those gene therapy approaches which require CD34 positive stem cells, it would not be applicable for say a gene therapy like an AAV gene therapy. So in looking at the gene therapy opportunities, our focus obviously would be on those that require stem cells in order to complete the gene therapy. That would be most definitely the focus as is with sickle cell as Phil just spoke of.

Speaker 2

Thanks, Holly. John, did that answer your question? Is there anything else?

Speaker 5

No, no, I appreciate the answers, Joe. Thank you.

Speaker 2

All right. Thanks so much. Have a great day.

Operator

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

Speaker 1

Hi, everyone. This is Lander on for Joe. Thanks for taking our question. So regarding the Phase 2 study in pancreatic cancer in China with Gloria, I wonder if you could provide some color on the preparations. Do you anticipate any difficulties with the Chinese agency or recruitment or site activation of the trial?

Speaker 1

And also, are there plans to expand to additional Asian territories besides Macau and Singapore? Thank you.

Speaker 6

Hi, this is Ella. Thank you for the question. With regards to the PDAC study in China, we are Gloria is planning to submit it to the regulatory authorities. And hopefully, the study can be initiated early by the end of this year or by the latest early next year. That's with regards to the PYDAC.

Speaker 6

I think the question you asked of expanding in the additional territories, you're relating to the PDAC. Was this question related to PDAC or stem cell mobility?

Speaker 1

Yes. Maybe both. It's Gloria. Are you planning on any agreement with Gloria to expand traditional territories besides China?

Speaker 2

Yes. So maybe I can take that. So first of all, in PDAC, I also want to answer the second part of your question. We patients able to bring a drug in 2 indications for approval in China within 4 years, which is on Western terms very, very significant and very quick. And so I think their ability to recruit the patients for the Phase 2b study in PDAC is quite significant and some of the institutions there are quite large in comparison to institutions in the West.

Speaker 2

As far as where they're going with the in other territories, I guess we can separate that into stem cell mobilization and PDAC. So with regard to stem cell mobilization, there are a number of territories because we have FDA approval, there are a number of territories in the Asia region, mostly in Southeast Asia like Singapore, some areas of China, I think Macau, etcetera that have a sort of an early access type of program where you can use a drug, a U. S. Labeled drug based on FDA approval and sell into the territory to various hospitals, etcetera, etcetera. And so they are working very diligently to try to start the commercialization very quickly in these smaller areas.

Speaker 2

But as far as the larger areas of the territory, for example, China, Japan and Korea, our assessment and their assessment as well is that there will probably be a bridging study, 1 or more bridging studies required that include Asian patients in order to get regulatory approval for stem cell mobilization. So that's regarding stem cell mobilization. With regard to pancreatic cancer, because pancreatic cancer has no approval anywhere, the pathway is obviously much longer. They're still they're going to be starting the trial in China. And I think that right now that's sort of the main focus in pancreatic cancer is to get the trial up and initiated in China and see what the results are and then based on that expand perhaps into other areas.

Speaker 2

We would be we're thinking as well about sometime down the road based on this data, interesting a partner or getting a partner interested in a large registrational Phase IIIII global trial, but that's a little bit down the road. But that's sort of the pathway right now for Gloria in Asia. I hope that answers your question.

Speaker 1

Perfect. Yes, that's very helpful. Thank you so much.

Speaker 2

Thank you.

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 3,9,250,904. Internationally, please call 9723 9,255,904. Mr. Serlin, would you like to make your concluding statement?

Speaker 2

Yes. Thank you, operator. In closing, we are progressing through 2024 with significant momentum, both with our ongoing commercial ramp of AFFXTA as well as the advancement of our development programs in pancreatic cancer and sickle cell disease. I am excited for what we are poised to accomplish over the remainder of this year and next. Thank you all very much for your continued interest in BioLineRx.

Speaker 2

We look forward to providing you our next comprehensive quarterly update in May. Be safe and have a great day.

Operator

Thank you. This concludes the BioLineRx 4th quarter 2023 conference call. Thank you for your participation. You may go ahead and disconnect.

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