BioLineRx Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 27, 2025

There are 9 speakers on the call.

Operator

Ladies and gentlemen, thank you for standing by. Welcome to BioLineRx First 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,

Speaker 1

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 six ks. I'd like to remind you that certain statements we make during the call will be forward looking.

Speaker 1

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 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.

Speaker 1

Phil Serlin, Chief Executive Officer of BioLineRx.

Speaker 2

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 Zebi, 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. In November of last year, we announced a transformational exclusive out licensing agreement with Aramid Pharma Limited.

Speaker 2

The agreement gives Aramid the rights to commercialize EFFECTZAR, our FDA approved stem cell mobilization agent indicated in combination with G CSF 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 Effexxa also known as metixafortide through clinical development and FDA approval in September 2023. We believe AIRMID is the ideal partner for Effexxa given that team's track record of success.

Speaker 2

As a reminder, the current AIRMID team established AMRID Bio in 2015 to focus on rare diseases. And in less than eight years they grew Amyrt revenue to an annual run rate of several hundred million dollars ultimately selling the company for approximately $1,500,000,000 In addition, the Aramid commercial portfolio also includes Omnisearch, the first and only FDA approved nicotinamide NAM modified cell therapy for patients with hematologic malignancies in need of transplant. So the addition of Effexxa is very complementary and while it has taken a few months to complete the transition, Effexxa has returned to growth and is performing well under Aramid 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.

Speaker 2

Since that announcement we have been laser focused on evaluating early clinical stage and late preclinical stage therapeutic assets 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 Aramid as well as our previously announced agreement with Gloria Bio. We continue to conduct due diligence discussions with a number of parties and I am optimistic that we'll make a definitive announcement later this year. The Airmen agreement also covers ongoing development of Afeksa in patients with sickle cell disease undergoing gene therapy.

Speaker 2

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 c d 34 positive hematopoietic hematopoietic stem cells and its 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 one investigator initiated trials that are ongoing. The first sickle cell disease trial is being sponsored by Washington University in St. Louis.

Speaker 2

An abstract detailing the initial results from this proof of concept study was presented at the sixty sixth annual American Society of Hematology annual meeting last December. The findings suggest that patients with sickle cell disease given metixafortide alone or in combination with natalizumab can mobilize and potentially collect a number of stem cells required for approved gene therapies in a single apheresis cycle. The second sickle cell disease trial is being sponsored by St. 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 AIRMET agreement and the transition of several members of the FormBioLineRx commercial team to AIRMET, late last year we announced the shutdown of our U.

Speaker 2

S. 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 burn by over 70% from over 40,000,000 annually to less than $12,000,000 as we entered 2025. Including a $10,000,000 financing that we completed in January, we ended the first quarter on a firm financial footing with cash of $26,400,000 and a cash runway projected to fund our operations through the second half of twenty twenty six. Turning now to pancreatic cancer or PDAC.

Speaker 2

We are continuing to support the development of metixafortide in this indication. Recall that metixafortide is an inhibitor of CXCR four, 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 seventy percent of PDAC patients show an over expression of CXCR4. PD-one and PDL-one inhibitors have demonstrated significant efficacy in multiple solid tumor types but no survival benefit in PDAC. In contrast, we previously completed a phase two trial in second line PDAC patients with metixafortide plus a PD-one inhibitor plus standard of care chemotherapy that demonstrated improvements across all study endpoints.

Speaker 2

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 two b PDAC trial sponsored by Columbia University and supported by both Regeneron and BioLineRx known as chemo for MET Panc 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 prespecified specified interim analysis is planned for when forty percent 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.

Speaker 2

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 that an abstract detailing new data from the pilot phase of the chemo for med peng trial has been accepted for presentation at the twenty twenty five annual meeting of the American Society of Clinical Oncology or ASCO. The presentation will take place at 9AM Central Daylight Time on Saturdays, May thirty first. Recall that in data previously presented, seven 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 sixty four percent which compares very favorably to the historical partial response rate of twenty three percent.

Speaker 2

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 progression free survival was nine point six months compared to historic median PFS of five point five months. Notably, an analysis of the biopsy samples demonstrated a significant increase in CD eight positive T cell density in tumors from all 11 patients treated, suggesting the ability of the metixafortide 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.

Speaker 2

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 pancreatic codueodenectomy with pathology demonstrating a complete response. Recall that it was due to these exceptional results from the pilot phase that the chemo for MET PANK Phase II 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 AIRMET together with a significantly streamlined organization and a 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 disease. Our goal continues to be to help as many patients as possible while creating enduring value for our shareholders.

Speaker 2

Before turning the call over to Mali to review our financials in more detail, I'd like to briefly touch on Ephexxa's performance in the first quarter. After a brief transition period in late twenty twenty four and early twenty twenty five, the Armed team has made very encouraging progress in driving EFFECSTA sales generating sales of $1,400,000 in Q1 twenty twenty five which resulted in $300,000 of royalty revenues to BioLineRx. We anticipated some modest and temporary softness in EFFECSTA sales in the first part of Q1 as a result of the transition to AIRMET. However, we have now seen it return to growth in late Q1 and early Q2. Now let me turn the call over to Molly to provide a financial update.

Speaker 2

Molly, go ahead.

Speaker 3

Thank you, Phil. As 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 six ks filing we made this morning, which contains our financials and press release. Total revenues for the quarter ended 03/31/2025 were $300,000 as compared to $6,900,000 for the comparable period in 2024.

Speaker 3

The revenues in 2025 reflect the royalties paid by AIRMET from the commercialization of Effexxa in stem cell mobilization in The U. S. The revenues in 2024 primarily reflect the 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 $5,900,000 as well as $900,000 of net revenues from product sales of Effexxa in The U. S. Cost of revenues for the quarter ended 03/31/2025 was immaterial compared to cost of revenues of $1,500,000 for the comparable period in 2024.

Speaker 3

The cost of revenues in 2025 reflect sublicense fees on royalties paid by AIRMET from the commercialization of Affecta in stem cell mobilization in The U. S. The cost of revenues in 2024 primarily reflects sub license fees on a milestone payment received under the Gloria Biosciences license agreement and royalties on net product sales of Afexta in The U. S, as well as amortization of intangible assets and cost of goods sold on product sales. Research and development expenses for the quarter ended 03/31/2025 were $1,600,000 compared to $2,500,000 for the comparable period in 2024.

Speaker 3

The decrease resulted primarily from lower expenses related to motixafortide due to the out licensing of U. S. Rights to ERMID 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 03/31/2025 compared to $6,300,000 for the comparable period in 2024. The decrease resulted primarily from the shutdown of U.

Speaker 3

S. Commercial operations in the fourth quarter of twenty twenty four following the AIRMAID out licensing transaction. Net income for the quarter ended 03/31/2025 were $5,100,000 compared to a net loss of $700,000 for the comparable period in 2024. The increase in net income stems primarily from non operating income associated with the reevaluation of warrants on our balance sheet. As of 03/31/2025 the company had cash, cash equivalents and short term bank deposits of $26,400,000 And with that I'll turn the call back over to Phil.

Speaker 2

Thank you, Molly 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

Thank The first question is from Joe Pantginis of H. C. Wainwright. Please go ahead.

Speaker 4

Hi everybody. Good morning, good afternoon. Can you hear me? Yes, we can. Great.

Speaker 4

Thank you. So first a couple of questions on the balance sheet and the P and 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.

Speaker 4

Okay. Then second, could elaborate what I think is No. No. No. That that's fine.

Speaker 4

Look. I mean, I know there's a bit of vagary there because we don't know what the asset is yet. You know, you have better better visibility, but that that's definitely good to know. So, no. That that's helpful.

Speaker 4

And then regarding overall P and L costs have the costs from the November restructuring worked their way through the P

Speaker 5

and L already? Yeah absolutely. Actually those costs were fully accrued already by the end of twenty twenty four and so there are no more anticipated costs at all in 2025.

Speaker 4

Great, I wanted to make sure. And then for chemo for MET PANK 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 you know the underlying unmet need?

Speaker 5

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 in The United Beth Israel and Wisconsin.

Speaker 6

Yes. And Fred Hutch is also about to participate.

Speaker 5

Correct and Fred Hutch as well.

Speaker 4

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

Speaker 6

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. We'll show some of the exciting data from the pilot phase.

Speaker 6

There is a great figure where you can see one tumor completely disappearing. There's a beautiful figure there. Also, is one in that poster, there is one patient where LiberMed also disappeared. So these are things although, as you said, anecdotally, not in all the patients but these are definitely things that are very exceptional and exciting.

Speaker 4

Got it. And then I guess a couple of 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 plan type of announcement to the public or will more data provided? And then the second part of the question is, you know, any views on the potential regulars regulatory strategy going forward, you know, looking at, say, breakthrough designation or even the potential to file on the chemo for med tank data based on potential

Speaker 5

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.

Speaker 5

And so we are somewhat limited, vis a vis their communication strategy. And so we, you know, 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 Columbia but it initially has to be published by Columbia 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.

Speaker 6

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's really more the chances are not very high that based on this study one could get regulatory approval.

Speaker 4

No, understood. Thanks for all the details guys.

Speaker 5

All right. Have a good day, Joe.

Operator

The next question is from Justin Walsh of Dillon's Trading. Please go ahead.

Speaker 7

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

Speaker 5

Yes, mean, you're so right we can't speak for Amirate but I will say that, you know, we we thought all along, I mean, you know, we talked a little bit about the size of the market that, you know, this was we estimated when when it was when it was in our hands and it's and it hasn't changed materially that this is overall about a $300,000,000 market, not that our product would take that whole market, but overall it was a $300,000,000 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 plus million 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, you know, number of years. Again, these are our estimations having nothing to do with, you know, AIRMET. I can't speak for AIRMET, but those are sort of our estimations throughout.

Speaker 5

And, you know, if you take the that sort of curve going, you know, going up over the next number of years, think that you can sort of 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. That's about as much as I can say.

Speaker 7

Yes, 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 kind 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.

Speaker 7

So curious as you guys follow the space what your thoughts are from a high level?

Speaker 5

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

Speaker 6

I think the headwinds with regards to the gene therapy.

Speaker 5

That's what I'm saying. Yeah, the gene therapy, absolutely. So because of obviously there are headwinds 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, you know, we have, you know, there's there's we have composition of matter coverage well into, you know, 02/1941.

Speaker 5

And so I think that we did see this as sort of a an a very significant upside to the asset over the next number of years. Maybe not initially but we because this is curative I think we've seen gene therapy is really taking hold and then therefore Affects as well moving in because it, you know, we see it as a superior mobilization agent and allowing the gene therapy companies to, you know, to reduce their costs of goods sold. We see that as far as the patients being able mobilize many more cells in many fewer sessions etcetera. So for all of those reasons we do see this as a potential significant upside for the asset.

Speaker 7

Great, thanks for taking the question. Okay.

Operator

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

Speaker 8

Great. Thank you and good morning and afternoon to you guys. Do we expect the proportion of license revenues for FX to continue at the rate that we saw in the first quarter? Was it $255,000,000 to like $1,400,000 Should we expect that to go on?

Speaker 5

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

Speaker 8

Yes. Yes. The license revenues to product revenues about 18% or so I guess which is on the low end of your Yes.

Speaker 5

I mean, are this is very typical in a license deal, they're tiered revenues. So until we reach a certain level of revenue of effectively reach a certain level of revenues, it will stay at 80% then it will go up to the next tier and then to the next tier, the next year. I mean we also have milestone based payments as well. I think that it's a total of up to $87,000,000 in milestone payments. So those payments as well could potentially inert to us over the next number of years.

Speaker 5

But, so 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.

Speaker 8

Okay. And then what's the visibility on the milestones? And I know you've got a couple of different sources, Gloria, Gamida 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?

Speaker 5

Yes. 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.

Speaker 8

Okay. I mean are there any like geographic related milestones if it expands? You know, and I'm talking about also on Gloria as well.

Speaker 4

Yeah. I mean, there are some yeah. I mean,

Speaker 5

are you talking about the Airman agreement or the Gloria agreement? So I because I think I'm Either

Speaker 8

one either one really, just, you know, in terms of the potential geographic expansion. Right.

Speaker 5

So the Glory agreement has both commercial milestones and development and regulatory milestones, because there are a number of additional, you know, territories, you know, China, Japan, Korea that, that require, you know, some development work and also some regulatory work. So that has a different set of milestones as well as commercial milestones. I believe the AMR agreement also has both indication based milestones as well as some geographic milestones.

Speaker 8

Okay. And a question on your search. Again, know you're keeping things pretty close to the vest on that. But I wanted to see what your thought process was. And I guess one of the aspects would be, looking for either well validated mechanisms or novel molecules.

Speaker 8

Do you take a stand on either one of those sides of things? I mean obviously there's benefits to each one.

Speaker 5

We're looking at everything. I think that we're doing a large and comprehensive search, 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 need to be know, as a smaller company, we need to be opportunistic. So we do have obviously a set of of of principles that are guiding us as far as the search, but we're also trying to be nimble and opportunistic as well.

Speaker 5

And so I can't give you a clear answer to that. I think the answer is that we're looking at everything.

Speaker 8

Okay. And just one more question on that aspect. 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 actions?

Speaker 5

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 in order to get to a value creating event. So 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 two or phase three 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.

Speaker 5

I think that's our ideal type of asset that we're looking at.

Speaker 8

Okay, great. Thank you, Phil. Appreciate

Speaker 5

Okay, have a great day.

Operator

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 U. S, please call 809-0634.

Operator

In Israel, please call 25004. Internationally, please call 972025004. Mr. Serlin, would you like to make your concluding statement?

Speaker 5

Yes. Thank you, operator. In closing, we are excited about this new vision 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.

Speaker 5

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

Operator

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

Powered by Quartr

Key Takeaways

  • BioLineRx signed a transformational out-licensing agreement with Aramid Pharma for Effexxa (metixafortide), securing an upfront payment plus future milestones and royalties while leveraging Aramid’s commercial expertise.
  • A strategic restructuring—including U.S. operations shutdown and Israeli headcount reductions—cut operating cash burn by over 70%, leaving $26.4 million on hand and a cash runway into H2 2026.
  • The ongoing randomized Phase IIb PDAC trial (Chemo for MET-Panc) with metixafortide plus a PD-1 inhibitor has shown a 64% partial response rate in the pilot, with an interim analysis planned in 2026 and an ASCO presentation on May 31.
  • Two investigator-initiated Phase I sickle cell disease trials are evaluating metixafortide’s ability to mobilize stem cells for gene therapy, with early results suggesting single-session collections may be feasible.
  • Q1 revenues dropped to $0.3 million from $6.9 million year-over-year due to the shift from upfront licensing payments to royalties, although a $5.1 million net income was recorded largely from a warrant revaluation.
AI Generated. May Contain Errors.
Earnings Conference Call
BioLineRx Q1 2025
00:00 / 00:00