BioLine RX Ltd (BLRX) 2025 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to BiolineRX first-quarter 2025 financial results conference call. (Operator Instructions) I would now like to turn over the call to Irena Kofler, Investor Relations. Irena, please go ahead.

Thank you, operator, and welcome everyone. Thank you for joining us on our quarterly results conference call. Earlier today, we issued a press release, a copy of which is available in the investor relations section of our website. It was also filed as a 6-K. I'd like to remind you that certain statements we make during the call will be forward-looking.

Because such statements deal with future events and are subject to many risks and uncertainties, actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 20-F and our quarterly reports on Form 6-K that are filed with the US 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.

In November of last year, we announced a transformational exclusive out licensing agreement with Ayrmid Pharma Limited. The agreement gives Ayrmid the rights to commercialize effects our FDA-approved stem cell mobilization agent indicated in combination with GCSF for the collection and subsequent autologous transplantation in patients with multiple myeloma. The agreement covers all indications excluding solid tumor indications and, in all territories, other than Asia. In exchange, we received an upfront payment as well as potentially significant commercial milestones and royalties.

Recall that we successfully shepherded Aphexda, also known as motixafortide, through clinical development and FDA approval in September 2023. We believe Ayrmid is the ideal partner for Aphexda, given that team's track record of success. As a reminder, the current Ayrmid team established Amrit Bio in 2015 to focus on rare diseases. And in less than eight years, they grew Ayrmid revenue to an annual run rate of several $100 million ultimately selling the company for approximately $1.5 billion.

In addition, the Ayrmid commercial portfolio also includes Omisirge, the first and only FDA approved nicotinamide NAM modified cell therapy for patients with hematologic malignancies in need of a stem cell transplant. So the addition of Aphexda is very complimentary. And while it has taken a few months to complete the transition, Aphexda has returned to growth and is performing well under Ayrmid stewardship, and I believe it will contribute incremental long-term value to our company through the potential milestones and royalties just mentioned. This 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.

Since that announcement, we have been laser focused on evaluating early clinical stage and late pre-clinical stage therapeutic acids in oncology and rare disease that will allow us to leverage our 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 efficient and clearly defined clinical development paths, and will be partly funded through milestones and royalties from our license agreements with Ayrmid as well as our previously announced agreement with Gloria Bio.

We continue to conduct due diligence and advance discussions with a number of parties, and I am optimistic that we will make a definitive announcement later this year. The Ayrmid Agreement also covers ongoing development of Aphexda in patients with sickle cell disease undergoing gene therapy.

Stem cell mobilization is a challenge for many sickle cell disease patients, as currently available gene therapies for sickle cell disease rely on the collection of significant quantities of CD34 positive hematopoietic stem cells, and this collection process often requires multiple apheresis sessions, which adds cost and complicates the patient journey.

In addition, many patients are ineligible for stem-cell transplantation because they are unable to mobilize the required numbers of cells for successful transplants. Hematopoietic stem cell transplantation after genetic modification is potentially curative for patients with sickle cell disease, and we eagerly await results from two Phase 1 investigator initiated trials that are ongoing.

The first sickle cell disease trial is being sponsored by Washington University in St. Louis. An abstract detailing the initial results from this proof of concept study was presented at the 66th annual American Society of Hematology Annual Meeting last December.

The findings suggest that patients with sickle cell disease, given motixafortide alone or in combination with natalizumab, can mobilize and potentially collect the number of stem cells required for approved gene therapies in a single apheresis cycle. The second sickle cell disease trial is being sponsored by Saint Jude Children's Research Hospital in Memphis, and is being executed by some of the leading sickle cell disease researchers in the world.

As a result of the Ayrmid agreement and the transition of several members of the Form BiolineRx commercial team to Ayrmid, late last year, we announced the shutdown of our US operations, and we also implemented a headcount reduction in Israel where BioLineRx continues to be based.

Together, these actions have allowed us to reduce our ongoing operating cash burden by over 70% from over $40 million annually to less than $12 million as we entered 2025. Including a $10 million financing that we completed in January, we ended the first quarter on a firm financial footing with cash of $26.4 million and a cash runway projected to fund our operations through the second half of 2026.

Turning now to pancreatic cancer or PDAC, we are continuing to support the development of motixafortide in this indication. Recall that motixafortide is an inhibitor of CXCR4, which plays a critical role in establishing and maintaining tumors. It is highly expressed in over 20 different tumor types, and it is estimated that greater than 70% of PDAC patients show an over expression of CXCR4.

PD-1 and PD-L1 inhibitors have demonstrated significant efficacy in multiple solid tumor types, but no survival benefit in PDAC. In contrast, we previously completed a Phase 2 trial in second line PDAC patients with the motixafortide plus a PD-1 inhibitor, plus standard of care chemotherapy.

That demonstrated improvements across all study endpoints. So while PDAC is an inherently challenging cancer to treat, there is very strong scientific rationale for continued development by us in this area.

To that end, a randomized Phase 2b PDAC trial sponsored by Columbia University and supported by both Regeneron and BioLineRx, known as CheMo4METPANC, continues to enroll patients. To further accelerate enrollment, last quarter, Columbia activated additional trial sites, and the trial is planned to be fully enrolled in 2027.

A pre-specified interim analysis is planned for when 40% of PFS events are observed, which is planned for 2026. 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 the CheMo4METPANC trial has been accepted for presentation at the 2025 Annual Meeting of the American Society of Clinical Oncology, or ASCO. The presentation will take place at 9 AM Central Daylight Time on Saturday, May 31.

Recall that in data previously presented 7 of the 11 patients in the pilot study experienced a partial response with six of those responses confirmed. That equates to a partial response rate of 64%, which compares very favorably to the historical partial response rate of 23%. 10 out of 11 patients, or 91% exhibited disease control, which also compares very favorably to a historic disease control rate of 48%. Additionally, median PFS progression pre-survival was 9.6 months compared to historic median PFS of 5.5 months.

Notably, an analysis of the biopsy samples demonstrated a significant increase in CD8+ T-cell density in tumors from all 11 patients treated, suggesting the ability of the motixafortide combination to overcome the immunosuppressive mechanisms within the tumor microenvironment that render other treatments ineffective. In the updated data to be presented at ASCO on Saturday, four patients have now been progression free for over a year. Two patients underwent definitive treatment for metastatic PDAC, one had complete resolution of all radiologically detected liver lesions, and underwent definitive radiations of the primary pancreatic tumor, while the other had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrated a complete response.

Recall that it was due to these exceptional results from the pilot phase that the CheMo4METPANC Phase 2 trial was amended to become the current ongoing randomized study with planned enrollment increasing from 30 patients to 108 patients. Suffice it to say that we continue to be very excited about the data emerging from this program.

In summary, with potential revenue from Ayrmid, together with a significantly streamlined organization and a strengthened balance sheet, we believe we are very well positioned to advance motixafortide and solid tumor indications such as pancreatic cancer while evaluating and in licensing additional assets in oncology and rare disease. 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 first quarter. After a brief transition period in late 2024 and early 2025, the Ayrmid team has made very encouraging progress in driving effects to sales, generating sales of $1.4 million in Q1 2025, which resulted in $0.3 million of royalty revenues to BioLineRx. We anticipated some modest and temporary softness in affects the sales in the first part of Q1 as a result of the transition to Ayrmid. However, we have now seen a return to growth in late Q1 and early Q2. Now, let me turn the call over to Mali to provide a financial update. Mali, please go ahead.

Thank you, Philip. It is our practice. I will only go over the most significant items in our financial statement: 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 financials and press release.

Total revenues for the quarter ended March 31, 2025, with $0.3 million as compared to $6.9 million for the comparable period in 2024. The revenues in 2025 reflect the royalties paid by Ayrmid from the commercialization of Aphexda in stem cell mobilization in the US.

The revenues in 2024 primarily reflect a portion of the upfront payments received under the Gloria license agreement, and the milestone payment achieved under the Gloria license agreement, which collectively amounted to $5.9 million as well as $0.9 million of net revenues from product sales of Aphexda in the US.

Cost of revenues for the quarter ended March 31, 2025, was immaterial compared to cost of revenues of $1.5 million for the comparable period in 2024.

The cost of revenues in 2025 reflects sub-license fees on royalties paid by Ayrmid from the commercialization of Aphexda in stem cell mobilization in the US. The cost of revenues in 2024 primarily reflects sub-license fees on a mass-on payment received under the Gloria Biosciences license agreement and royalties on net product sales of Aphexda in the US, as well as amortization of intangible assets and cost of goods sold on product sales. Research and development expenses for the quarter ended March 31, 2025, were $1.6 million compared to $2.5 million for the comparable period in 2024.

The decrease resulted primarily from lower expenses related motixafortide due to the outlicensing of US 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 quarter ended March 31, 2025, compared to $6.3 million for the comparable period in 2024.

The decrease resulted primarily from the shutdown of US commercial operations in the fourth quarter of 2024 following the Ayrmid out licensing transaction. Net income for the quarter ended March 31, 2025, worth $5.1 million compared to a net loss of $0.7 million for the comparable period in 2024. The increase in net income stems primarily from non-operating income associated with the revaluation of warrants on our balance sheet.

As of March 31, 2025, the company had cash equivalents and short-term bank deposits of $26.4 million. And with that, I'll turn the call back over to Phil.

Thank you, Mali, and thank you to everyone joining this call. We will continue to update you on our progress identifying new assets over the course of the year. With that, we have now concluded the formal part of our presentation. Operator, we will now open the call to questions.

(Operator Instructions) Joe Pantginis, HC Wainwright.

So first, a couple of questions on the balance sheet and the P&L, if you don't mind. So first, wanted to check on the cash runway stated. Does this include any new asset coming in for projected development costs on your end, which you also stated these costs could also be offset by potential milestones and effects to royalties?

Yes, it does.

Okay.

Then second, I could elaborate (multiple speakers) No, that's fine. Look, I mean, I know there's a bit of vagary there, because we don't know what the asset is yet, you have better visibility, but that, that's definitely good to know. So no, that's helpful. And then regarding overall P&L costs, have the costs from the November restructuring worked their way through the P&L already?

Yeah, absolutely. Actually, those costs were fully accrued already by the end of 2024. And so there were no more anticipated costs at all in 2025.

Great, wanted to make sure. And then for CheMo4METPANC, I guess first some anecdotal and then some specific questions. So any anecdotes you can add or provide with regard to the sites that have been added that might be linked to say excitement to join the study and the underlying unmet needs?

Yeah, I'm trying to think if we gave that information. It's probably in clinicaltrials.org, I imagine. I mean, the sites in the study originally were Columbia and Brown University, and two more sites have added [Beth] Israel and Wisconsin. (inaudible) And Fred Hutch as well.

Yeah. No more of the excitement that these sites wanted to join the study, from an anecdotal standpoint with regard to seeing the opportunities out there, and that sort of links to my amended question to that of -- any competition for enrollment and with regard to pancreatic studies out there?

Yes, okay. So yes, the sites definitely are excited to join. I think the poster that is going to be presented at [Ash], will show some of the data -- at ASCO sorry, will show some of the exciting data from the pilot phase. There's a great figure where you can see one tumor completely disappearing. There's a beautiful figure there.

Also, there is one -- in that poster there is one patient where [Liber Med] also disappeared. So these are things, although, as you said, anecdotal or -- not in all the patients, but these are definitely things that are very exceptional and exciting.

Got it. And then, I guess a couple looking-forward questions. I guess, part one is when you talked about the interim analysis at 40% PFS events, was just curious about the communication strategy around this. Is this a canonical, continuous plans type of announcement to the public, or will more data provided? And then the second part of the question is any views on the potential re regulatory strategy going forward, looking at say breakthrough designation or even the potential to file on the CheMo4METPANC data based on potential strength.

Okay, so I can start take the first part of that question. As you know, we're not running the study, right? It's a collaboration with Columbia University and the -- and Columbia is leading it. And so we are somewhat limited, vis-a-vis their communication strategy. And so we have to be aligned with their communication strategy.

So we certainly in our collaboration agreement we're allowed to put out data once it's published by Colombia, but it initially has to be published by Colombia, and so we're limited about as to what we can say right now and how much control we have over it. But of course we will be putting out that data as soon as it comes out.

With regard to the second part of your question, if based on this study, one could consider going for regulatory approval just to be fair. Usually, those studies in order to get approval, require primary endpoint of overall survival, and this study, as you know, has PFS as the primary endpoint. So of course, everything will depend if the results will be completely outstanding, but I think that that's really more -- the chances are not very high that based on this study one could get regulatory approval.

No, understood. Thanks for all the details, guys.

All right, have a good day, Joe.

Justin Walsh, Dylan's Trading (sic – JonesTrading).

Hi, thanks. This is Justin from JonesTrading. Now that Aphexda is returning to growth but out of your hands, I'm wondering if you can provide any color on what your expectations are and the long term opportunity for the asset there. I mean, obviously you can't speak for Ayrmid, of course.

Yeah, I mean, You're so right, we can't speak for Ayrmid, but I will say that we thought all along, I mean, we talked a little bit about the size of the market that this was we estimated when it when it was in our hands and it's -- and it hasn't changed materially, that this is overall about a $300 million market. Not that our product would take that whole market, but overall it was a $300 million market, and that we would be able to take a substantial portion of that market.

And so if you just look at the entire opportunity, I think that you could infer from that that this is an opportunity in the $100 million-plus range. And so I think that's more or less what you could say as far as -- how you see the revenues of this product going up over the next (inaudible) number of years. Again, these are our estimations having nothing to do with Ayrmid. I can't speak for Ayrmid, but those are sort of our estimations throughout. And if you take that sort of curve going in or up over the next number of years, I think that you can extrapolate from that. How we see this asset, if we're getting an 18% to 23% royalty on it as we move forward. I hope that helps as that's about as much as I can say.

Yeah, no, it does. And maybe one quick follow up. Curious what your thoughts are on the current trajectory of the cell and gene therapy fields. I think there's been a lot of headwinds from a funding perspective, and maybe some of the initial commercial opportunities haven't been quite as high as people had hoped. But of course, this is still potentially curative opportunities out there for a lot of these. So curious as you as you guys follow a space for your thoughts are from a high level.

Yeah, I mean, I think that we do see the same a little -- some headwinds at the beginning and et cetera. But you know this is a long term play. We didn't expect that Aphexda would immediately enter the market as far as from a sickle cell disease perspective. We see it long term as you know --

I think the headwind's as what's discussed, the gene therapy --

That's what I'm saying, yeah, the gene therapy, absolutely. So because obviously, there are heads in the gene therapy, the use of mobilization agents is obviously going to be limited as well. But I think that we always saw this as a longer term play and we have -- there's, we have composition of matter coverage well into 2041. And so I think that we did see this as -- and a very significant upside to the acid over the next (inaudible) number of years, not -- maybe not initially, but we -- because this is curative, I think we've seen gene therapy is really taking hold, and then therefore affects it as well moving in. Because it -- we see it as a superior mobilization agent and allowing the gene therapy companies to reduce their cost of goods sold. We see that as far as the patients being able to mobilize many more cells in many fewer sessions, et cetera. So for all of those reasons, we do see this as a potential significant upside for the acid.

Great, thanks for taking the question.

Okay.

John Vandermosten, Zacks.

Great, thank you and good morning and afternoon to you, guys. Do we expect the proportion of license revenues for Aphexda to continue at the rate that we saw in the first quarter $255 million to $1.4 million to expect that to go on --

You're saying that the ratio of royalty revenues to revenue to Aphexda revenues? I just want to make sure I understand your question.

Yes, yeah. The license revenues, the product revenues. About 18% or so, I guess, which is on the low end of your --

Yeah, well, I mean, these are -- this is very typical of a license deal. They're tiered revenues. So until we reach a certain level of [revenue] effectively reach a certain level of revenues, it will stay at 180%, then it will go up to the next tier, and then to the to the next tier, the next tier. I mean, we also have milestone based payments as well. I think that it's a total of up to $87 million in milestone payments.

So those payments as well could potentially inert to us over the next number of years. But so we we're expecting both royalty revenues on a regular basis and milestone payments if we reach the milestones that are set forth in the agreement.

Okay, and then what's the visibility on the milestones, and -- you've got a couple of different sources, Gloria [Gameda] cell for that. You may not be able to tell me the timing, but maybe just the milestone type or whatever kind of visibility you can provide us as we forecast out on that on future milestones?

Yeah, so because this is a commercial stage asset, the milestones are primarily commercial based, right? Not development based, and not regulatory based, but commercial based, but that's as bad as much as I could tell you.

Okay, I mean, are there any geographic related milestones if it expands, and I'm talking about Gloria as well?

I mean there are some, yeah, I mean, are you talking about the Ayrmid agreement or the Gloria agreement? So I --

I think either one, really. Just in terms of potential geographic expansion.

Right. So the Gloria Agreement has both commercial milestones and development and regulatory milestones because there are a number of additional territories in China, Japan, Korea, that require some development work and also some regulatory work. So that has a different set of milestones as well as commercial milestones. I believe the Ayrmid agreement also has both indication-based milestones as well as some geographic milestones.

Okay, and a question on your on your search. Again, I know you're keeping things pretty close to the vest on that. But I wanted to see what your pro -- your thought process was. And I guess one of the aspects would be looking for either well validated mechanisms or novel molecules. Do you take a stand on either one of those sides of things? I mean, obviously, there's benefits to each one.

We're looking at everything. I think that we're doing a large and comprehensive search of -- with the help of consultants, and we've identified a number of potential assets. And we're working to diligence these programs, we're also going to need to be -- as a smaller company, we need to be opportunistic. So we do have obviously a set of principles that are guiding us as far as the search, but we're also trying to be nimble and opportunistic as well. And so I can't give you a clear answer to that. I think that the answer is that we're looking at everything.

Okay. And just one more question on that aspect, and I know again, you're probably -- you're not going to share the whole thing with me. But there's also looking at small markets with little-to-no competition or deep markets where there's an unmet need that you think you can address. Is that -- when you talk about your principles, is that something that you look at as well on those two [actors]?

We're looking at everything. I do want to add, I mean, I think that we're looking for programs that have a relatively short pathway and a lean clinical development program and in order to get to a value-creating event.

So that I think that that's sort of something that. Could help you understand what we're looking at. I think we're not looking at massive indications that require an enormous -- a large Phase 2 or, Phase 3, or anything like that. We're looking at more modest programs again that have a short pathway, a short clinical development pathway, and a lean clinical development program. I think that's our ideal type of asset that we're looking at.

Okay, great, thank you, Phil. I appreciate it.

Okay, have a great day.

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 in two hours after the conference. In the US, please call 1-888-295-2634. In Israel, please call 039255-904. Internationally, please call 972-392-55904. Mr. Serlin, would you like to make your concluding statement?

Yes, thank you, operator. In closing, we are excited about this new visions for BioLineRx, and we are working diligently to identify new assets for in licensing and development that would expand our pipeline and give us additional opportunities for value creation. We believe this path forward best positions us to create value for our shareholders while developing novel new therapies for patients with cancer and serious rare diseases.

Thank you all very much for your continued interest in BioLineRx. We look forward to providing our next comprehensive quarterly update in August. Be safe and have a great day.

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