BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx second quarter 2025 financial results conference call. All participants are present in listen-only mode. Song management formal presentation instructions will be given for the question and answer session. I would now like to turn over the call to Irina Kossler, 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 6K. 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-X and our quarterly reports on Form 6-K that are filed with the U.S. Securities and Exchange Commissions. At this time, it is now my pleasure to turn the call over to Mr. Phil Sterling, 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 Molly Zeppe, our Chief Financial Officer, to briefly recap our financials. Afterwards, we will take your questions. Ellis Narani, our Chief Development Officer, is also available for Q&A. I'd like to begin this morning with an update on our search for additional early-stage assets, both clinical and preclinical, in the areas of oncology and rare diseases to support our pipeline expansion. I am pleased to report today that we are making excellent progress in our evaluation of promising assets, and we continue to target the execution of a transaction this year. giving us an additional opportunity to deliver innovation to patients while creating long-term value for our shareholders. For those who may be new to our story, in November of last year, we announced a transformational exclusive out-licensing agreement with Aramid Pharma Limited, which gave them the rights to commercialize effect stuff. Our FDA-approved stem cell mobilization agent indicated in combination with GCSF with a collection and subsequent oncology transplantation in patients with multiple myeloma. That agreement covers all indications, excluding solid tumor indications such as pancreatic ductal adenocarcinoma or PDAC, for which we retain the rights, and in all territories other than Asia. In exchange, we receive an upfront payment as well as commercial milestones and royalties. In addition to being approved for stem cell mobilization, Afexa is also being studied in two investigator-sponsored phase 1 trials, evaluating it for the mobilization of CD34-positive hematopoietic stem cells using the development of gene therapies for patients with tickle cell disease. The first study is evaluating metixoportide as monotherapy and in combination with natalizumab and is sponsored by Washington University School of Medicine in Cambridge. Data from this program are expected in the second half of this year. The second study is evaluating metixifortide as monotherapy and is sponsored by St. Jude's Children's Research Hospital. So while it is early, the potential broad clinical utility of metixifortide, including in sickle cell disease, represents an additional potential source of long-term milestones and royalties for our company. As previously mentioned, as part of the ARAMID agreement, we retain the rights to metixifortide in pancreatic cancer, and which continues to support its ongoing development in this education. To that end, a randomized Phase IIb PDAC trial sponsored by Columbia University and supported by both Regeneron and BioLineRx, known as Chemo4MedPank, continues to enroll patients. The Chemo4MedPank trial is evaluated in metixoportiside in combination with the PD-1 inhibitor, Simplimab, and standard of care chemotherapy, gemcitabine, and napaclitaxel. A pre-specified interim analysis is planned for when 40% of progression-free survival events are observed. Results from this trial, if positive, could be a significant value reflection point for our company and signal new hope for patients suffering from this very challenging tumor type. We look forward to keeping you up to date on our progress for this important program. And staying on the topic of the Columbia University PDAC study for a moment, We were very pleased to announce that an abstract detailing new data from the pilot phase of this trial was presented at the 2025 Annual Meeting of the American Society of Clinical Oncology, or ASCO, in May. Recall that in previously presented data, seven of the 11 patients in the pilot study experienced a partial response, with six of those confirmed. That equates to a partial response rate of 64%. which compares very favorably to the historical partial response rate of 23%. 10 of 11 patients, or 91%, exhibited disease control, which also compares very favorably to a historic disease control rate of 48%. Additionally, median PFS was 9.6 months compared to historic median PFS of 5.5 months. Notably, An analysis of biopsy samples demonstrated a significant increase in CB8-positive 2-cell density in tumors from all 11 patients treated, suggesting the ability of the multisupport type combination to overcome the immunosuppressive mechanisms within the tumor microenvironment that render other treatments ineffective. In the updated data that was presented at ASCO, more patients have now been progression-free for over a year. Two patients underwent definitive treatment for metastatic PDAC. One had a complete resolution of all radiologically detected liver lesions and underwent radiation to the primary pancreatic tumor, while the other had a sustained partial response and underwent a pancreatic code duodenectomy, better known as a Whipple procedure, with pathology demonstrating a complete response. We are very excited about the data that continue to emerge from this program. While Matissa Fortide represents an unequivocal demonstration of our ability to develop and launch a new therapeutic agent, the AMA transaction enabled us to return to our roots as a highly innovative company in complex drug development with a very experienced team and a validated track record of clinical and regulatory success. Recall that we successfully advanced Metixifortide, known commercially as Afexa, through clinical development and FDA approval in September 2023, giving new hope to the increasing number of multiple myeloma patients who may benefit from an autologous stem cell transplant, yet who have difficulty mobilizing the significant quantities of stem cells required for successful transplantation. Since the Aramid Agreement, we have been major focused on evaluating early clinical stage and late preclinical stage therapeutic assets in oncology and rare diseases that will allow us to leverage this proven expertise in drug development and expand our pipeline. I am pleased to report that we continue to evaluate several promising candidates that fit our criteria. Importantly, the subsequent development of any candidates that we identify will have an efficient, and clearly defined clinical development path, and will be partly funded through milestones and royalties from our license agreement, with Aramid as well as from our previously announced agreement with Gloria Bio. The current pace of due diligence is actively progressing, and as I said, we are targeting a definitive announcement this year. I want to underscore that our diligence process is lengthy and intensive and includes deep verification of preclinical data, intellectual property, and drug manufacturing processes. This thorough process is expected to generate the best result for our shareholders. Our whole team has been engaged in these activities since the beginning of the year. In this regard, we are pleased to be well financed as we undertake this endeavor. We ended the second quarter with cash and equivalents of approximately $28.2 million. which is sufficient to fund our operating plan as currently contemplated into the first half of 2027. Note that this represents an extension of our cash runway as compared to our previous license, which was through the second half of 2026. Following the announcement of the airman out licensing agreement, several BioLine RX commercial team members transitioned to Airbnb, and we also implemented the broad restructures of our company, including the shutdown of our U.S. operations. That resulted in more than a 70% reduction in our operating cash flow as we entered this year. These decisions, while difficult, have transformed us into a lean and nimble organization capable of quickly seizing on new opportunities that are consistent with our go-forward strategy for the company. In summary, with potential revenue from Airman and Gloria Biosciences, together with a significantly streamlined organization and strengthened balance sheet, we believe we are very well positioned to advance metixoportide and solid tumor indications such as pancreatic cancer while evaluating and licensing additional assets in oncology and rare diseases. Our goal continues to be to help as many patients as possible while creating enduring value for our shareholders. Before turning the call over to Molly to review our financials in more detail, I'd like to briefly touch on Apexa's performance in the second quarter. The Aramid team continues to make progress driving Apexa's adoption, generating sales of $1.7 million in Q2 2025, which resulted in $0.3 million of royalty revenue for myeloma effects. We remain optimistic about the role that Apexa can play in the new multiple myeloma treatment paradigm. as well as in sickle cell disease, and look forward to meaningful growth as proven protocols are updated to reflect the commercial availability of this next-generation stem cell mobilization agent. Now let me turn the call over to Molly to provide a financial update. Molly, please go ahead.

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 six-page filing we made this morning, which contains our financials and press release. Total revenues for the second quarter of 2025 were $0.3 million, reflecting the royalties paid by EIRMIT from the commercialization of Apexa in Spencer Mobilization in the U.S. Cost of revenues for the second quarter of 2025 was immaterial, compared to cost of revenues of $0.9 million for the second quarter of 2024. Both revenues and cost of revenues in 2025 are not comparable to the same period in 2024, which primarily related to direct commercial sales by BioLinerX prior to the AMI transaction in November 2024. Resource and development expenses for the second quarter of 2025 were $2.3 million, compared to $2.2 million for the second quarter of 2024. The small increase related primarily from certain one-time costs associated with the PIDAC study at Columbia University, offset by lower expenses related to MOTIC supported, due to out-licensing of U.S. rights to EIRMID, 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 second quarter of 2025 compared to $6.4 million for the second quarter of 2024. The decrease resulted from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the ERMI transaction. General and administrative expenses for the second quarter of 2025 were $0.2 million compared to $1.6 million for the second quarter of 2024. The decrease resulted primarily from the reversal of a provision for doubtful accounts following receipt of an overdue milestone payment from Gloria, a decrease in 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 second quarter of 2025 was $3.9 million compared to net income of $0.5 million for the second quarter of 2024. As of June 30, 2025, the company had cash, cash equivalents, and short-term bank deposits of $28.2 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, Molly, and thank you to everyone joining this call. Operator, we will now open the call to questions.

Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. If you have a question, please press star 1. Please stand by while we poll for your questions. The first question is from Joe Pantinus of H.C. Wainwright. Please go ahead.

Hey, everybody. Good morning. Thanks for taking the questions. A few, if you don't mind. So first, Phil, can you remind us, with regards to the Kela for MedTank study, does Regeneron have any options or right of first looks or refusals?

No, they do not. This is a clinical, both sides, it's just a clinical collaboration. We have access to the data down the road, but there's no option for, as far as I know, Well, on our part, for sure, and as far as I know, there's no option on the regenerative side either.

Got it. And then with regard to the conduct of the study and the data, you obviously state, and we all knew this anyway, that you need a 40% PFS event rate to be able to trigger an interim there. Do you anticipate that that would – release data or be sort of a continuous plan type of announcement? And then overall, when the studies are completed, you know, based on the unmet medical need, do you believe there's any potential for filing on this study for an accelerated standpoint? Ella, would you like to take that?

Yeah, I can take that. So with regards to the interim analysis, it's a pre-specified interim analysis in the protocol, so... it will be performed with regards to the publication. It's in, you know, Tim, I'll leave it to you. It's in the University of Michigan study.

I don't know if... Tim, I would like to... I think that we have every... we would like to publish that data, at least that the study is continuing, et cetera, et cetera. I think that that's our goal. I think we have to close that issue with Columbia. And also, I believe that they have the rights to publish that data first, so the timing of it might be, you know, we will have to discuss it with them to understand the timing. Understood. You go ahead, sorry.

I got to you a second. If based on this internal analysis, it would be, you know, a way forward with regards to accelerated approval. I doubt it because, you know, it's 40% of the events in this 108% patient study will probably not be sufficient in order to result in accelerated approval in terms of this and also it's based on PFS while as you know the standard primary endpoint for approval will be overall survival. So I don't see the result in accelerated approval based on interim analysis of reporting 40% of the event.

Okay, understood. Thank you. And then you guys are obviously busy with your academic collaboration, so I want to focus specifically on the sickle cell study. If you could sort of give us, you know, what should we in the street be looking for out of the study with regards to, you know, key metrics and endpoints, overall expectations?

I mean, you know, generally we'll be looking at the mobilization. There will be mobilization data coming out of these studies, both at the WashU, for example. The WashU study is both the metixoportide as a monotherapy and also metixoportide together with the natalizumab. And so there should be, again, these are initiated studies, but there should be data relating to the mobilization of both of those arms. Any other questions?

Yes, I can add to that. So, of course, one of the most important endpoints of this study is safety because it's the first time that sickle cell disease patients have been mobilized with motifs of heart attack. The second aspect is, of course, the mobilization into peripheral blood. So, cells for microliter in the peripheral blood, which is correlative to the collection years. And the first would be collection years in sickle cell disease patients. As you remember, there was preliminary results presented in last year's ASCO as an oral presentation, results from seven patients, which showed very promising results in all these parameters. especially if you compare it to this dose of control of fluoxifil-4. For example, just to remind you, the mobilization to peripheral blood, the mean and median values with motififil-4 types were the median was around 200 cells per microliter, the mean was 300 cells per microliter. If you compare this to the benchmark of mobilization with fluoxifil-4, you know, less than 100 days for microliters, just as a high-level comparison. And also the collection yields were very high and promising, and so this, I think, will be the outcome from this study. What you will not get from this study, of course, is the data on manufacturing.

Understood. And then my last question, if you will, obviously you've been very busy in the background with regard to all the due diligence and looking at new assets. So if I heard you correctly, Phil, correct me if I'm wrong, it seemed like there were sort of two that were sort of at the forefront right now. Are you able to share at least, I mean, you provided some timing of potential confirmation of the deals, but sort of the stages of these assets? Is the potential to be accretive or late stage? How should we sort of view this for near to intermediate term impact on the P&L?

Yeah, so we are targeting closing a transaction this year. I can't promise that it will happen, but we're targeting closing a transaction this year. We're looking for early stage. We're looking in our sweet spot, our wheelhouse, which is early clinical stage assets, from IND through Phase I. That's sort of where we're looking. We're also looking for assets that have a very clear and well-defined development plan, Something that we can afford. Also, transactability is important for us, right? So we're not looking at assets that require a significant upfront payment, et cetera, et cetera. So we've had a lot of experience in bringing in assets over the years. We've brought in over 50 assets over the 20-year life of the company. These assets that we're looking for are very much in our wheelhouse, both from a development perspective, a cost perspective, a transactability perspective, and also in the areas that we have expertise in, in oncology, et cetera.

Appreciate all the added details. Thanks a lot.

The next question is from Justin Walsh of Jones Trading.

Hi, thanks for taking the question. Can you provide any additional color on how your ASCO data was received? I don't know if you had an interesting feedback from physicians or potential partners or a conference.

The ASCO data from the pancreatic study you mean?

Yes, yes.

Okay, yes. So what I can tell you that there was excitement. aspects in the results that are very promising, in particular the results on the liver mets, which is something that is very, you know, unusual to see a reduction in liver mets. So we received very exciting feedback with that regard, in particular to that finding.

Great. Thanks for taking the question.

The next question is from John von der Molsten of ZAP. Please go ahead.

Great. Thank you. And just some more questions on your progress in finding new assets. What are the most attractive sources that you've identified for some of the pipeline candidates? You know, I generally think of their universities, public-private companies, big pharma that, you know, has something that they don't have time for, maybe too small. For them, what are some of the sources that you're looking at?

Yes, that's a good question. We're looking at all of those sources, of course. I'd have to say generally, and these are broad generalizations, academic institutions are less of a source from our perspective for clinical stage projects. They usually are at earlier stages of development. So, you know, we're looking at them, you know, also, of course, but we're finding that there's that they're a much better source of interesting and innovative early stage projects. On the other hand, if I go to the other extreme, so to speak, and that's the pharma companies, there are very interesting assets available. I think that from our perspective, we're finding that from a transactability perspective, it's difficult for us to compete in those areas that usually require a significant upfront payment and early-stage milestones, et cetera, et cetera. And we're trying as much as possible to spend very little to nothing upfront and enable us to spend all of the spend on development, et cetera, and have a back-ended type of deal. So I have to say, in conclusion, I have to say that overall, the best scores that we're finding are the smaller companies both private and public, mostly private because it's very difficult to raise money right now. And so we are finding interesting assets at smaller companies that have brought the assets to a certain milestone, so to speak, but don't have the capital or the development expertise necessarily to move those assets further. And so this is exactly our wheelhouse. Again, sort of early clinical stages, We have, you know, this is what we've been doing for the last 20 years. And so this is probably the best source of assets for our pipeline expansion activities.

Okay. Yeah, that makes perfect sense. And then, you know, given the funding environment, which you mentioned, you know, do you feel like you have the upper hand in negotiating? You know, you've got a long history of doing this, and I guess compared to previous years, Does it seem like you're in a little bit stronger position now than you were in the last 20 years?

That's a very good question. I think we are in a better position as far as that we have a validated development history. I think when we were looking for assets 10 years ago, because we really haven't done much in licensing activities. We spent the last 10 years or so primarily on most of the foresight. I think that before we had the validation from our entire clinical development capabilities that we've shown in the six reports, I think that there was maybe, again, years ago, there was skepticism about when we came and said that we can really do everything and bring this forward. I think we're finding that the validation that we have from having had the approval you know, it really resonates. And so, therefore, it is somewhat easier now versus in the past for us to make the case that, you know, if you give us the asset, maybe we can't compete financially with someone else, but we can bring it forward in the quickest, most efficient manner all the way through, you know, potential approval. And so that is resonating better.

Okay, great. Thanks, Bill.

This concludes the question and answer session. Before I ask Mr. Phil Furlan 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 03-9255-904. Internationally, please call 972-3-9255-904. Mr. Thurland, would you like to make your concluding statement?

Yes, thank you, Operator. In closing, we remain very excited about this new vision for BioLineRx, and we are making excellent progress in our due diligence as we work to identify new assets for in-licensing and development. that would expand our pipeline and give us additional opportunities for value creation. As mentioned, we are targeting a potential announcement this year. Thank you all very much for your continued interest in BioLineRx. We look forward to providing our next comprehensive quarterly update in November. Be safe and have a great day.

Thank you. This concludes the BioLineRx second quarter 2025 conference call. Thank you for your participation. You may go ahead and disconnect.