BioLineRx Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 14, 2025

Key Takeaways

  • Positive Sentiment: Company is making “excellent progress” in identifying and evaluating early-stage oncology and rare disease assets, targeting execution of a new licensing transaction this year to expand its pipeline.
  • Positive Sentiment: Interim data from the Phase 2b PDAC trial showed a 64% partial response rate and median progression-free survival of 9.6 months versus a historic 5.5 months, with four patients now progression-free over a year and a prespecified interim analysis at 40% PFS events expected to be a potential value inflection point.
  • Positive Sentiment: Two investigator-sponsored Phase 1 studies in sickle cell disease are evaluating motixafortide as both monotherapy and in combination with natalizumab, with key safety and mobilization data—including CD34+ cell yields—expected in the second half of this year.
  • Neutral Sentiment: The company closed Q2 with $28.2 million in cash and equivalents—extending its runway into 2027—after reducing operating cash burn by over 70% through restructuring and the Aramid and Gloria licensing agreements.
  • Positive Sentiment: Q2 sales of Afexa reached $1.7 million, generating $0.3 million in royalties, reflecting growing adoption in multiple myeloma stem cell mobilization protocols.
AI Generated. May Contain Errors.
Earnings Conference Call
BioLineRx Q2 2025
00:00 / 00:00

There are 4 speakers on the call.

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second Quarter twenty twenty five Financial Results Conference Call. I would now like to turn over the call to Irina Koffler, Investor Relations. Irina, please go ahead. Thank you, operator, and welcome, everyone.

Operator

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 six ks. 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.

Operator

For a full discussion of these risks and uncertainties, please review our annual report on Form 20 F and our quarterly reports on Form six ks 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 Curlin, Chief Executive Officer of BioLineRx.

Speaker 1

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 Zebbe, our Chief Financial Officer, to briefly recap our financials. Afterwards, we will take your questions. Ella Sarani, our Chief Development Officer, is also available for q and a.

Speaker 1

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 the 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, we announced a transformational exclusive out licensing agreement with Aramid Pharma Limited, which gave them the rights to commercialize Effexxa, our FDA approved stem cell mobilization agent indicated in combination with G CSF with 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 all territories other than Asia. In exchange, we received an upfront payment as well as commercial milestones and royalties.

Speaker 1

In addition to being approved for stem cell mobilization, Effexxa is also being studied in two investigator sponsored Phase one 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 with tixaportide 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 metixafortide as monotherapy and is sponsored by St.

Speaker 1

Jude Children's Research Hospital. So while it is early, the potential broad clinical utility of metixafortide, 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 retained the rights to metixafortide 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 for med tank, continues to enroll patients. The chemo for MET PANK trial is evaluating metixafortide in combination with the PD-one inhibitor cineplimab and standard of care chemotherapy gemcitabine and nab paclitaxel.

Speaker 1

A prespecified interim analysis is planned for when forty percent 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 PDX study for a moment, we were very pleased to announce an abstract detailing new data from a pilot phase of this trial was presented at the twenty twenty five 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.

Speaker 1

That equates to a partial response rate of sixty four percent, which compares very favorably to the historical partial response rate of twenty three percent. Ten of eleven patients or ninety one percent exhibited disease control, which also compares very favorably to a historic disease control rate of forty eight percent. Additionally, median PFS was nine point six months compared to historic median PFS of five point five months. Notably, an analysis of biopsy samples demonstrated a significant increase in CD8 positive T cell density in tumors from all eleven 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, four patients have now been progression free for over a year.

Speaker 1

Two patients underwent definitive treatment for metastatic PDAC. One had a complete resolution of all radiologically detected liver lesion and underwent radiation to the primary pancreatic tumor, while the other had a sustained partial response and underwent a pancreatic codulodenectomy, 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 metixafortide represents an unequivocal demonstration of our ability to develop and launch a new therapeutic agent, the Amory 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 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.

Speaker 1

Since the Aramed 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 continued 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.

Speaker 1

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 $28,200,000 which is sufficient to fund our operating plan as currently contemplated into the 2027.

Speaker 1

Note that this represents an extension of our cash runway as compared to our previous guidance, which was through the 2026. Following the announcement of the AIRMID Allied licensing agreement, several BioLineRx commercial team members transitioned to AirMed, and we also implemented a broad restructuring of our company, including the shutdown of our US 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 AIRMID and Gloria Biosciences, together with a significantly streamlined organization and strengthened balance sheet, we believe we are very well positioned to advance metixafortide in solid tumor indications such as pancreatic cancer, while evaluating and in licensing additional assets in oncology and rare diseases.

Speaker 1

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 Ephexxa's performance in the second quarter. The Aramid team continues to make progress driving Ephexxa adoption, generating sales of $1,700,000 in Q2 twenty twenty five, which resulted in $300,000 of royalty revenues to BioLineRx. We remain optimistic about the role that affects the 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 Molly to provide a financial update.

Speaker 1

Molly, please go ahead. Thank you, Phil.

Speaker 2

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 case filing we made this morning, which contains our financials and press release. Total revenues for the 2025 were 300,000, reflecting the royalties paid by Aramid from the commercialization of Afexta in Stem Cell Mobilization in The US. Cost of revenues for the 2025 was immaterial compared to cost of revenues of $900,000 for the 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 Hermit transaction in November 2024.

Speaker 2

Research and development expenses for the second quarter of twenty twenty five were $2,300,000 compared to $2,200,000 for the 2024. The small increase related primarily from certain onetime costs associated with the PEDEX study at Columbia University, offset by lower expenses related to motixafortab due to out licensing of U. S. Rights to Aramid, 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 2025 compared to $6,400,000 for the 2024.

Speaker 2

The decrease resulted from the shutdown of U. S. Commercial operations in the 2024 following the AirMe transaction. General and administrative expenses for the 2025 were $200,000 compared to $1,600,000 for the 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.

Speaker 2

Net loss for the 2025 was $3,900,000 compared to net income of $500,000 for the 2024. As of 06/30/2025, the company had cash, cash equivalents and short term bank deposits of $28,200,000 sufficient to fund operations is currently planned into the 2027. And with that, I'll turn the call back over to Phil.

Speaker 1

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

Operator

Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. The first question is from Joe Pantginis of H. C. Wainwright.

Operator

Please go ahead.

Speaker 1

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

Speaker 1

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 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. Got it.

Speaker 1

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 forty percent 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, 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?

Speaker 3

Yeah. I can take this. So with regards to the interim analysis, it's it's it's a pre specified interim analysis in the protocol. So if we will perform with regards to the publication, it's in, you know, same. I'm I'm maybe to you, it's an investor initiated study.

Speaker 3

I don't know if Yes.

Speaker 1

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

Speaker 1

You go ahead. Sorry.

Speaker 3

Because here, second, if based on this internal analysis, it would be, you know, a a way forward with regards to accelerated approval. I doubt it because, you know, it's it's forty percent of the events in this 108 patient study will probably not be sufficient in order to to result in accelerated approval in terms of of of this. And also, it's 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 falling forty percent of the event.

Speaker 1

Okay. Understood. Thank you. And then you guys are obviously busy with your academic collaboration. So I wanna to focus specifically on the sickle cell study.

Speaker 1

If you could sort of give us what should we in the street be looking for out of the study with regard to key metrics and endpoints, the overall expectations? I mean, generally, we'll be looking at the mobilization. There'll be mobilization data coming out of these studies, both at the WashU, for example, the WashU study is both metixaplortide as a monotherapy and also metixaplortide together with metanatolizumab. 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 Yes.

Speaker 3

I I can answer 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 with motixa for that. The second aspect is, of course, the mobilization into peripheral blood. So sales per microliter in the peripheral blood, which is correlative to the collection yield. And the the first would be collection use in sickle cell disease patients.

Speaker 3

As you remember, the there was a 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 source control of PLEXO4. For example, just to remind you, the mobilization to peripheral blood, the mean and median value of this Clarixa four type where 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 Glorixafor, it's less than 100 sales per microliter, just as a high level comparison. And also the collection yields very high and promising. And so this this, I think, will be the outcome from from this study.

Speaker 3

What you will not get from this study, of course, is the data on manufacturing.

Speaker 1

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 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 consummation of the deals, but sort of the stages of these assets?

Speaker 1

Is potential to be accretive or late stage? How should we sort of view this for near to intermediate term impact on the P and L? Yes. 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.

Speaker 1

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. 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?

Speaker 1

So we're not looking at assets that require a significant upfront payment, etcetera, etcetera. So we have a lot of experience in bringing in assets over the years. We've brought in over 50 assets over the twenty 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, in oncology, etcetera. The

Operator

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 if you had an interesting feedback from physicians or or potential partners at conference.

Speaker 1

Let me ask you.

Speaker 3

Ask for data from from the pancreatic study, you mean?

Operator

Yes. Yes.

Speaker 3

Okay. Yeah. So so what I can tell you 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 reduction in liver mass. So received very exciting feedback with that regards in particular to that finding.

Operator

Great. Thanks for taking the question. The next question is from John Vundermilson of Zacks. Please go ahead.

Speaker 1

Great. Thank you. And just to ask 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? Generally think of their universities, public private companies, big pharma that has something that they don't have for, maybe it's too small for them.

Speaker 1

What what are what are 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 now these are broad generalizations.

Speaker 1

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 they're a much better source of interesting and innovative early stage projects. On the other hand, if you look at you 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.

Speaker 1

Those usually require a significant upfront payment and early stage milestones, etcetera, etcetera. 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, etcetera, in 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.

Speaker 1

Again, sort of early clinical stages, we have this is what we've been doing for the last twenty 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?

Speaker 1

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 twenty years other periods in the last twenty 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 ten years ago, because we really haven't done much in licensing activities.

Speaker 1

We've spent the last ten 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 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.

Operator

Okay. Great.

Speaker 1

Thanks, Phil.

Operator

This concludes the question and answer session. Before I ask mister 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 two hours after the conference. In The US, please call +1 (888) 295-2634. In Israel, please call 039255904. Internationally, please call 97239255904.

Operator

Mr. Thirlin, would you like to make your concluding statement?

Speaker 1

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.

Speaker 1

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

Operator

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

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