BioLineRx Ltd. (BLRX) Q2 2025 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second Quarter 2025 Financial Results Conference Call. [Operator Instructions] 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 were 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'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 Ayrmid Pharma Limited, which gave them the rights to commercialize APHEXDA, our FDA-approved stem cell mobilization agent indicated in combination for the collection and subsequent autologous 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 received an upfront payment as well as commercial milestones and royalties. In addition to being approved for stem cel mobilization, APHEXDA is also being studied in 2 investigator-sponsored Phase I trials, evaluating it for the mobilization of CD34-positive hematopoietic stem cells used in the development of gene therapies for patients with sickle cell disease. The first study is evaluating motixafortide as monotherapy and in combination with natalizumab and is sponsored by Washington University School of Medicine in St. Louis. Data from this program are expected in the second half of this year. The second study is evaluating motixafortide as monotherapy and is sponsored by St. Jude's Children's Research Hospital. So while it is early, the potential broad clinical utility of motixafortide, 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 Ayrmid agreement, we retained the rights to motixafortide in pancreatic cancer, and we continue to support its ongoing development in this indication. To that end, a randomized Phase IIb PDAC trial sponsored by Columbia University and supported by both Regeneron and BioLineRx known as CheMo4METPANC continues to enroll patients. The CheMo4METPANC trial is evaluating motixafortide in combination with the PD-1 inhibitor, cemiplimab, and standard of care chemotherapy, gemcitabine and nab-paclitaxel. A prespecified 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 inflection 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 with 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 previous presented data, 7 of the 11 patients in the pilot study experienced a partial response, with 6 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 CD8-positive T cell density in tumors from all 11 patients treated suggesting the ability of motixafortide combination to overcome the immunosuppressive mechanisms within the tumor microenvironment that render other treatments ineffective. In the updated data that was presented at ASCO, 4 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 a pancreatic 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 motixafortide represents an unequivocal demonstration of our ability to develop and launch a new therapeutic agent, the Ayrmid 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 motixafortide known commercially as APHEXDA 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 Ayrmid agreement, we have been laser-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. 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 Ayrmid 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 results for our shareholders. Our whole team has 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 guidance, which was through the second half of 2026. Following the announcement of the Ayrmid out-licensing agreement, several BioLineRx commercial team members transitioned to Ayrmid, and we also implemented a broad restructuring of our company, including the shutdown of our U.S. operation that resulted in more than a 70% reduction in our operating cash burn 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 Ayrmid and Gloria Biosciences, together with a significantly streamlined organization and strengthened balance sheet, we believe we are very well positioned to advance motixafortide in solid tumor indications such as pancreatic cancer, while evaluating and in-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 Mali to review our financials in more detail, I'd like to briefly touch on APHEXDA's performance in the second quarter. The Ayrmid team continues to make progress driving APHEXDA adoption, generating sales of $1.7 million in Q2 2025, which resulted in $0.3 million of royalty revenues to BioLineRx. We remain optimistic about the role that APHEXDA can play in the new multiple myeloma treatment paradigm as well as in sickle cell disease and look forward to meaningful growth as treatment protocols are updated to reflect the commercial availability of this next-generation stem cell mobilization agent. Now let me turn the call over to Mali to provide a financial update. Mali, 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 6-K filing we made this morning, which contains our financial and press release. Total revenues for the second quarter of 2025 were $0.3 million reflecting the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. Cost of revenues for 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 Ayrmid transaction in November 2024. Research 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 onetime costs associated with the PDAC study at Columbia University, offset by lower expenses related to motixafortide due to 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 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 Ayrmid 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, 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.

A few, if you don't mind. So first, Phil, can you remind us with regard to the CheMo4METPANC study, does Regeneron have any options or right of first looks or refusals?

No, they do not. This is a clinical -- for 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 for a part for sure. And as far as I know, there's no option on the Regeneron side either.

Got it. And then with regard to the conduct of the study and the data, you obviously stated 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 study is completed based on the unmet medical need, do you believe there's any potential for filing on this study for an accelerated standpoint?

Mali, would you like to take that?

Yes, I can take that. So with regard to the interim analysis, it's a prespecified interim analysis in the protocol. It will be performed with regards to the publication. It's in -- Phil, I'll leave it to you, it's an investigor-initiated study. I don't know if...

Yes. I would like to -- I think that we have every -- we would like to publish that data or 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 Colombia. And also, I believe that they have the rights to publish that data first. So the timing of it might be -- we will have to discuss it with them to understand the timing.

Understood. Go ahead, sorry.

With regard to your second, if based on this interim analysis, it would be a way forward with regards to accelerated approval. I doubt it because it's -- 40% of the events in this 100 patient study will probably be sufficient in order to result in accelerated approvals 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 it result in accelerated approval based on interim analysis of following 40% of the events.

Okay. Good. 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 what should we and the industries be looking for out of the study with regard to key metrics and end points, the overall expectations?

I mean, generally, we'll be looking at the mobilization. There will be mobilization data coming out of these studies, both at the WSHU, for example, the WAHU study is both motixafortide as a monotherapy and also motixafortide together WITH natalizumab. And so there should be -- again, these are investigator-initiated studies, but there should be data relating to the mobilization of both of those arms. Any other data...

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 motixafortide. The second aspect is, of course, the mobilization into peripheral blood. So cells per microliter in the peripheral blood, which is correlative to the collection yield. And the third would be collection yield in sickle cell disease patients. As you remember, there was a preliminary results presented in last year's ASCO as an oral presentation, results from 7 patients, which showed very promising results in all these parameters, especially if you compare it to the historical control of plerixafor. For example, just to remind you, the monetization to peripheral blood, the mean and median values with motixafortide where the median was around 200 cells per microliter. That mean was 300 cells per microliter, you compare this to the benchmark of mobilization with plerixafor. It's less than 100 cells per microliter, just as a high-level comparison. And also the collection yields, the very high and promising. And so this, I think, will be the outcomes from this study. What you will not get from this study, of course, is data on manufacturing.

Understood. And then my last question, if you will. Obviously, you've had -- you've been very busy in the background with regard to all the due diligence in looking at new assets. So if I heard you correctly, Phil, correct me if I'm wrong, it seemed like there were sort of 2 that were sort of at the forefront right now. Are you able to share at least -- I mean you provided some timing of potential consummation of the deals, but sort of the stages of these assets? Is it potential to be accretive or late stage? How should we sort of view this for near to intermediate-term impact on the P&L?

Yes. So we're 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. These are -- 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 have 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. And so this is sort of 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 oncology, et cetera.

The next question is from Justin Walsh of Jones Trading.

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 at the conference.

ASCO data.

ASCO data from the pancreatic study, you mean?

Yes. Yes.

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

The next question is from John Vandermosten of Zacks.

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

Yes, that's a good question. I -- We're looking at all of those sources, of course. I'd have to say generally, and these are broad generalization. Academic institutions are less of a source from our perspective for clinical stage projects. They usually are at earlier stages of development. So we are looking at them 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 you look -- and if I go to the other extreme, so to speak, and that's the -- for 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. There 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 back end and have a back-ended type of deal. So I have to say -- in conclusion, I have to say that overall, the best source 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 -- 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. Yes, that makes perfect sense. And then given the funding environment, which you mentioned, how -- do you feel like you have the upper hand in negotiating? You've got a long history of doing this. And I guess compared to previous periods, does it seem like you're in a little bit stronger position now than you were in the last 20 years -- other periods 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've spent the last 10 years or so primarily on motixafortide, right? So I think that before we had the validation from our entire clinical development capabilities that we've shown in -- with motixafortide, 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 that we -- I think we're finding that with the validation that we have from having FDA approval and even is -- really resonates. And so therefore, it is somewhat easier now versus in the past for us to make the case that 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 potential approval. And so that is resonating better.

This concludes the question-and-answer session. 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 (888) 295-2634. In Israel, please call (03) 9255-904. Internationally, please call 9723-9255-904. Mr. Serlin, 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.