Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Third Quarter 2025 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn over the call to Irina Koffler, Investor Relations. Irina, please go ahead.

Thank you, operator, and welcome, everyone. Thank you for joining us on our quarterly 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 as a 6-K. I'd like to remind you that certain statements we make during the call will be forward-looking. Because 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-K that are filed with the U.S. Securities and Exchange Commission. At this time, it is now my pleasure to turn the call over to Mr. Phil Serlin, Chief Executive Officer of BioLineRx.

Thank you, Irina, and good morning, everyone, and thank you for joining us on today's call. As has been our practice, I will begin with a few prepared remarks before turning the call over to Mali Zeevi, our Chief Financial Officer, to briefly recap our financials. Afterwards, we will take your questions. Ella Sorani, our Chief Development Officer, is also available for Q&A. I would like to begin this morning with a recap of our very significant and transformational announcement that we established a JV with Hemispherian, a Norwegian privately held biotech company to develop GLIX1, a highly innovative molecule for the treatment of glioblastoma and other cancers. The JV combines our proven track record of clinical and regulatory success, having advanced APHEXDA through clinical development and FDA approval with Hemispherian's expertise in small molecule cancer drug discovery, specifically in the area of DNA damage response research that leverages a unique mechanism of action and targets cancer cells. With these complementary capabilities, I believe we are very well positioned to bring much needed innovation to the most challenging cancer types while creating long-term value for our respective shareholders. GLIX1 is a first-in-class oral small molecule. As mentioned, GLIX1 is a very innovative molecule with a unique mechanism of action that targets DNA damage response in cancer cells while sparing healthy cells. Based on this unique MOA, the fact that it crosses the blood-brain barrier as well as highly impressive preclinical results, the first indication to be investigated will be glioblastoma or GBM, both newly diagnosed and recurrent. The FDA cleared Hemispherian's IND in August. And with the JV now up and running, we are planning to initiate a first-in-human Phase I/IIa glioblastoma trial in the first quarter of next year. At the same time, GLIX1 is a versatile molecule that…

Thank you, Phil. As is our practice, I will only go over the most significant items in our financial statements, revenues, cost of revenues, research and development expenses, sales and marketing expenses, net loss and cash. I invite you to review the 6-K that we filed this morning, which contains our financials and press release. Total revenues for the third quarter of 2025 were $0.4 million, reflecting the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. Cost of revenues for the third quarter of 2025 was immaterial. Both revenues and cost of revenues in 2025 are not comparable to the same period in 2024, which primarily reflect a portion of the upfront payments received by us under the Gloria license agreement as well as direct commercial sales of APHEXDA by BioLineRx prior to the Ayrmid transaction in November 2024. Research and development expenses for the third quarter of 2025 were $1.7 million compared to $2.6 million for the third quarter of 2024. The decrease resulted primarily from lower expenses related to motixafortide following the out-licensing of U.S. rights to Ayrmid as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount. There were no sales and marketing expenses for the third quarter of 2025 compared to $5.5 million for the third quarter of 2024. The decrease resulted primarily from the shutdown of our U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid out-licensing transaction. General and administrative expenses for the third quarter of 2025 were $0.8 million compared to $1.4 million for the third quarter of 2024. The decrease resulted primarily from lower payroll and share-based compensation, primarily due to a decrease in headcount as well as small decreases in a number of general and administrative expenses. Net loss for the third quarter of 2025 was $1 million compared to net loss of $5.8 million for the third quarter of 2024. As of September 30, 2025, the company had cash, cash equivalents and short-term bank deposits of $25.2 million, sufficient to fund operations as currently planned into the first half of 2027. And with that, I'll turn the call back over to Phil.

Thank you, Mali, and thank you to everyone joining this call. Operator, we will now open the call to questions.

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

If you don't mind, I'm going to ask all 3 of my questions at the same time because there is some background noise. So please bear with me. So first, I wanted to get a sense as we look towards the upcoming clinical study for GLIX1, as you look early on for PK and PD markers, are there any potential PD markers that you look to release that might be correlated with clinical activity as people look to tease out any additional information from the study, number one. Number two, what would you say your intermediate or longer-term needs are for manufacturing capacity for GLIX1? And number three, thank you for taking these as you look towards additional tumor indications, when do you think we might see some preclinical data readouts and what those indications might be?

Thanks, Joe. So first of all, thanks for joining the call. Ella, do you want to take the question?

Yes, sure. Joe, thanks for your question. So the first question with regards to PK and PD markers during the clinical trial of GLIX. PK is an easy one. Of course, we are planning to take extensive PK data during this trial. With regards to pharmacodynamic markers, we do have pharmacodynamic markers for GLIX1. However, they are from biopsies. And since we are talking in the first part at least of the study, about recurrent GBM -- biopsies during or following treatment will not be easy to be obtained. Having said that, if there are going to be surgeries along the trial, then we are planning to use those in order to get some input with regards to these biomarkers. I hope this answers the question.

Yes.

And as far as the immediate needs for manufacturing, I can say that we're manufacturing at a world-class CDMO. We don't anticipate any need to change manufacturers or whatever. I think the current manufacturer has more than enough capacity and the batch size is correct for us to move forward all the way to Phase IIa.

And regarding your third question on results of preclinical models. So we are performing then with regards to when we will be able to present results probably in -- well, the plan would be in one of the conferences next year.

The next question is from John Vandermosten of Zacks.

So why the activities to commercialize APHEXDA are responsible at Ayrmid, I wanted to see if you can help me think about like a medium-term target for market penetration based on today's vantage point. Is that something you can help me with, Phil?

We can't really help you with it. We're not -- we're no longer the owner, so to speak, of the asset in the territories that Ayrmid holds. And so we're not really giving guidance at this time since it's no longer our product. I wish I could give you a better answer than that, but I'm really not able to.

Okay. And then shifting on to GBM. What would be a reasonable target for an improvement in overall survival for GBM that would get established pharma interested and get the FDA to be on board with approval? I know, again, that's well down the road, but I was wondering what you had in mind in terms of what would be material enough to get all parties, all stakeholders interested?

Yes. So with regards to that, I think it depends, of course, if you're talking recurrent GBM or newly diagnosed GBM. I think for the newly diagnosed, the benchmark would be -- I mean, temozolomide was approved based on improvement of median overall survival of approximately 2.5 months. So that would probably be sufficient for -- in terms of improvement of overall survival for newly diagnosed GBM. For recurrent GBM, I think the bar would even be lower in terms of improved efficacy.

Okay. That's very helpful. And then just a question on the financial statements. So your investments in the JV, how will they appear on your financial statements? Is that considered R&D expense? Or will it end up somewhere else? And I know there's a few different components there, like a periodic piece and then the investments in the JV itself.

Yes. So we ultimately control the JV. We have control of the Board of Directors, and we also have control of the joint development committees, et cetera. So we're actually consolidating the JV in our financial statements. And so therefore, all of the expenses in the JV will be reflected in the specific financial statement line items as if we were -- as if it was just being done directly at BioLine.

Okay. So those are all considered R&D expense, including that, I think that $80,000 amount.

Yes, of course. Yes. That $80,000 amount is actually -- is for specific services, transition services and what have you. So it will all be reflected in R&D expenses, I believe you're correct.

[Operator Instructions] There are no further questions at this time. Mr. Serlin, would you like to make your concluding statement?

Yes, I would. Thank you, operator. In closing, we remain very excited about this new vision for BioLineRx and believe we have the expertise and resources to drive meaningful innovation for patients with some of the most challenging cancer types. I am very excited about what the future holds for BioLineRx in 2026 and beyond. Thank you all very much for your continued interest in BioLineRx. Be safe, and have a great day.