BioLineRx - Earnings Call - Q2 2025

Transcript

Speaker 5

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. Following the management's formal presentation, instructions will be given to the question and answer session. I would now like to turn over the call to Irina Koffler, Investor Relations. Irina, please go ahead.

Speaker 6

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 statement. For a full discussion of these risks and uncertainties, please review our annual report on Form 20F and our quarterly reports on Form 6K 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. Philip Serlin, Chief Executive Officer of BioLineRx.

Speaker 0

Thank you, Irina, and good morning, everyone. 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 the transformational exclusive out-licensing agreement with Ayrmid Pharma Ltd., which gave them the rights to commercialize Effexta, our FDA-approved stem cell mobilization agent indicated in combination with TCSF, with 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 all territories other than the U.S. In exchange, we received an upfront payment as well as commercial milestones and royalties. In addition to being approved for stem cell mobilization, Effexta 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 sickle cell disease.

The first study is evaluating motixafortide as monotherapy and in combination with natalizumab, and is sponsored by Washington University 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 Children's Research Hospital. 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 Pharma agreement, we retain the rights to motixafortide in pancreatic cancer, and we continue to support its ongoing development in this indication. To that end, a randomized Phase 2b PDAC trial sponsored by Columbia University and supported by both Regeneron and BioLineRx, known as chemo 4-MET Tank, continues to enroll patients.

The chemo 4-MET Tank trial is evaluating motixafortide in combination with a PD-1 inhibitor, simvapamab, and standard of care chemotherapy, gemcitabine and nab-paclitaxel. A pre-specified interim analysis is planned for when 40% of progressing stage 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 with this important program. Staying on the topic of the Columbia University PDAC study for a moment, we were very pleased to announce 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%. Ten 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 a 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 the motixafortide combination to overcome the immunosuppressive mechanisms within this tumor microenvironment that render other treatments ineffective. In the updated data that was presented at ASCO, four 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 lymph lesions and underwent radiation to the primary pancreatic tumor, while the other had a sustained partial response and underwent a pancreatic choledochoduodenectomy, better known as the 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 Effexta, to 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. 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 licensed agreements, with Ayrmid as well as from our previously announced agreement with Gloria Bio. The current phase 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 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 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. 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 Ayrmid and Gloria Bio, 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 enlightening additional aspects 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 Effexta's performance in the second quarter. The Ayrmid team continues to make progress driving Effexta 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 Effexta 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.

Speaker 3

Thank you, Pri. 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 G&A. 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 Ayrmid Pharma from the commercialization of Effexta in stem cell 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 Ayrmid Pharma 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 to certain one-time 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 Pharma, 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 Pharma 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 a slip and an overdue milestone payment from Gloria Bio, 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 a 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. I'll turn the call back over to Phil.

Speaker 0

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

Speaker 5

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

Speaker 4

Hey, everybody. Good morning. Thanks for taking the questions. A few, if you don't mind. First, Phil, can you remind us, with regard to the chemo 4-MET Tank study, does Regeneron have any options or right of first look for refusals?

Speaker 0

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

Speaker 4

Got it. 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? When the study's completed, 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?

Speaker 2

Yeah, I can take that. With regards to the interim analysis, it's a pre-specified interim analysis in the protocol. It will be performed with regards to the publication. It's in, you know, Phil, I'm leaving it to you. It's an investigative study. I don't know if.

Speaker 4

I think that we have every, we would like to publish that data at least, or at least that the study is continuing, etc. I think that's our goal. I think we have to close that issue with Columbia University. 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.

Speaker 0

Understood. You go ahead. Sorry.

Speaker 2

regards to your second, if based on this interim 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. Also, it's based on PFS, while, as you know, the standard primary endpoint for approval will be overall survival. I don't see it as a result in accelerated approval based on interim analysis of following 40% of the events.

Speaker 0

Okay. Understood. Thank you. You guys are obviously pretty 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 in the suite be looking for out of the study with regard to key metrics and endpoints, the overall expectations?

Speaker 4

I mean, you know, generally, we'll be looking at the mobilization. There'll be mobilization data coming out of these studies, both as a walkthrough. For example, the walkthrough study is both motixafortide as a monotherapy and also motixafortide together with nab-paclitaxel and natalizumab. 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?

Speaker 2

Yes, I can add to that. Of course, one of the most important endpoints of this study is safety because it's the first time that the sickle cell disease patients have been mobilized with motixafortide. A second aspect is, of course, the mobilization into peripheral blood. Cells per microliter in the peripheral blood, which is the correlative to the collection years, and the third would be collection years in sickle cell disease patients. As you remember, there were 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 the historical control of motixafortide. For example, just to remind you, the mobilization to peripheral blood, the mean and median value of motixafortide 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 peripheral, it's less than 100 cells per microliter, just as a high-level comparison. Also, the collection years were very high and promising. This, I think, will be the outcomes from this study. What you will not get from this study, of course, is the data on manufacturing.

Speaker 0

Understood. 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. If I heard you correctly, Phil, correct me if I'm wrong, it seemed like there were sort of two that were 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 the stages of these assets, is the potential to be accretive or late stage? How should we view this for near to intermediate-term impact on the P&L?

Speaker 4

Yeah. We are targeting closing a transaction this year. I can't promise that it'll 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 one. 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? We're not looking at assets that require a significant upfront payment, etc. 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.

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, etc.

Speaker 0

Appreciate all the added details. Thanks a lot.

Speaker 5

The next question is from Justin Walsh of Drones Trading.

Speaker 1

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 interesting feedback from physicians or potential partners at a conference.

Speaker 2

I mean, ASCO data from the pancreatic study, you mean?

Speaker 1

Yes. Yes.

Speaker 2

Okay. What I can tell you is that 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, to see reduction in liver mets. We received very exciting feedback with that regard, in particular to that finding.

Speaker 1

Great. Thanks for taking the question.

Speaker 5

The next question is from John Vandermosten of Zacks. Please go ahead.

Speaker 4

Thank you. This is 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? I generally think of various 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?

Speaker 0

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. We're looking at them also, of course, but we're finding that they're a much better source of interesting and innovative early-stage projects. On the other hand, if you look at, and 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. These usually require a significant upfront payment, and early-stage milestones, etc., etc.

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, etc., and back end, and have a back-ended higher deal. 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. 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. This is exactly our wheelhouse. Again, sort of early clinical stages. We have a, this is what we've been doing for the last 20 years. This is probably the best of the list of assets for our pipeline expansion activities.

Speaker 4

Okay. Yeah, that makes perfect sense. 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. 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, another period in the last 20 years?

Speaker 0

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? I think that before we had the validation from our entire clinical development capabilities that we've shown with motixafortide, there was maybe, years ago, skepticism about when we came and said that we can really do everything and bring this forward. I think that the validation that we have from having FDA approval really resonates.

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. That is resonating better.

Speaker 4

Okay. Great. Thanks, Phil.

Speaker 5

This concludes the question and answer session. Before I ask Mr. Philip Serlin 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 9723-9255-904. Mr. Serlin, would you like to make your concluding statement?

Speaker 0

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.

Speaker 5

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