BioLineRx Ltd. Q3 FY2024 earnings call

• Announced exclusive license agreement with Ayrmid Limited for motixafortide (APHEXDA), including $10M upfront, $87M potential milestones, and 18%-23% royalties. - Shut down U.S. commercial operations, reduced cash burn, and extended cash runway to 2026. - Reviewed PDAC program progress, including CheMo4METPANC Phase 2b trial with positive pilot phase results. - CFO Mali Zeevi recapped financials, noting revenue, expenses, net loss, and cash position.

Total revenue for the three months ended September 30, 2024 was $4.9 million. Revenue included $3.2 million from the Gloria Biosciences license and $1.7 million from APHEXDA product sales. Cost of revenue was $0.8 million. Research and development expenses were $2.6 million, sales and marketing expenses were $5.5 million, general and administrative expenses were $1.4 million. Net loss for the period was $5.8 million. As of September 30, 2024, cash, cash equivalents, and short-term bank deposits were $29.2 million, expected to fund operations into 2026.

• Anticipate adding 3 new clinical trial sites to CheMo4METPANC Phase 2b trial in first-line PDAC, with interim data in 2026. - Expect continued progress with Gloria Bio on stem cell mobilization bridging and Phase 2b combination study. - Plan to evaluate early-stage clinical assets in oncology and rare disease, seeking to add 1 asset in 2025 and 1 in 2026.

Q: Did you say potential in-licensing of one asset in '25 and one in '26?

A: Yeah. I think that's what our plan is. We have a number of assets that we're already looking at. It's hard to say, BD things don't always go exactly according to plan. But I think overall, that's our plan.

Q: How do we mix the pancreatic program with potential motixafortide in additional solid tumor indications and business development discussions?

A: As far as the PDAC, I think that we look at PDAC as sort of, as a prototype, so to speak for other solid tumors. We are probably not going to put a lot more money at this point into PDAC. As you know, we have the two collaborations that are ongoing that are really running in the background with -- at a very low cost to the company, basically drug, the supply of drug product. And so, we think the best use for our current capital is to bring some new assets into pipeline while these programs are still ongoing. And we hope that there will be some initial data sometime next year -- I'm sorry, next in 2026, some interim data from the Columbia study, which then would serve as probably the launching off point for some potential business development discussions, etc.

Q: Do they have any potential option on the solid tumor program?

A: They do not.

Q: With regard to the company restructuring, it sounds like that it's mostly or largely the field force that they'll be assimilating?

A: Not necessarily. I mean, I don't think we're going to -- liberty to tell you to speak for them. But they have -- they are taking a piece of our organization or a number of our personnel. And I don't think it's only limited to field to customer-facing employees.

Q: From a financial standpoint and the important details you shared with regard to the drug launch to-date. How should we sort of view to the level of detail you can, sort of, the integration time within their program of APHEXDA and how that might impact any potential lags or dips in sales?

A: Yeah. So I mean, I'm hoping that there won't be too much of a lag in anything. I mean they're taking, like I said, a significant number of employees with them. We’re also according to the agreement, we’re providing them with transition services for the next number of months. And so we think we’re going to ASH. We’ll probably going to Tandem as well. So I think that we believe that the transition period should be quite seamless. And I don’t believe there will be a significant lag in sales or in the uptick of sales.

Q: Can you provide some color on where you view the company's core competencies as we wait to hear more about the addition of potential assets to your pipeline?

A: Thanks, Justin. Good morning. So I mean, as we mentioned, we'll be returning to our roots as an Israeli-based development company. But with many -- I think that we have many positive attributes that other companies may not have. We have a highly experienced development team, with fully validated capabilities from early-stage projects all the way to approval and of course, commercialization, but I'll just talk about until approval. So those are some of our capabilities. We have full -- our Israeli team has full capabilities in regulatory affairs and CMC, and quality assurance, in clinical operations in preclinical development, etc. So I mean, we've got in medical affairs and etc. So we've got a full complement of the disciplines necessary to move forward in development. I think if you just even to go further with that, I think that we also have cash flows from two partnering arrangements that will provide commercial milestones and royalty revenues on an ongoing basis that other development companies might have. And we also have, as I mentioned, we have the significant trials in PDAC that are ongoing under these meaningful collaborations that are really forward at a de-minimis cost to the company. So I think all-in-all, I think that we feel that we're very well placed moving forward. And again, as I mentioned, we're looking to bring in at two new assets in the 2025, 2026 period. We have a list of potential in-license candidates. All of them sort of meet our criteria of a low upfront payment in oncology and rare disease with relatively modest and affordable clinical development program. So I mean that's sort of how we see ourselves moving forward. I hope that gave you a comprehensive answer to your question.

Q: Looking at the 2025 expenses. I think you indicated there would be a 70% reduction in spend next year. And I guess if we look at kind of the estimates out there, it seems like we just took out sales and marketing expense and leave R&D and G&A kind of as they have been -- is that a fair way to look at it?

A: I think it's going to be a little bit more than that. I think we're going to -- as a company that also had operations in the U.S. besides the actual U.S. commercial operations, I think that some of our spend from Israel, having a U.S. subsidiary that was active, created some additional spend. So I think it's a little bit more than that. I think you can expect a decrease in G&A expenses as well and etc. So we're looking to be lean and mean going forward. And as I said, we believe that we will be on the right track with moving forward with development only in Israel. Again, I think I also want to mention that Israel itself is sort of a low cost place to have development and so I think that we are looking at over 70% reduction overall in the spend.

Q: On the R&D side, should we think of that kind of continuing on at the same level? And what are those obligations going to be? I mean, I think there's PDAC in there. Is there anything else in there that's ongoing?

A: Yeah. So we are -- we have some obligations regarding some five year commitment, post-marketing commitment with the FDA, but that's not very significant. And as well our PDAC commitments are more -- our drug supply plus some small grant, nothing significant. So I mean, we're going to be having two PDAC -- two Phase 2b studies, hopefully ongoing at almost no cost to the company. The post-margin commitment will be quite low. And then the rest of our spend will be on new projects as we bring them in.

Q: As we look at potentially a pivotal or registrational trial in PDAC. I guess you seem to indicate that, that would be taken over by partners and that you would probably have limited contribution there?

A: Yeah. I mean, listen, everything is possible, but I think we believe that something of this size in solid tumors in general, it would make sense to partner, especially have very robust data from the Phase 2b -- or from the Phase 2b. So I think our probably -- our main path we forward would be to look to partner it out and this being such a blockbuster indication, we don't really think that it would be difficult depending, of course, on the data.

Q: On China, it seemed like you had mentioned that there's a clearance there, I guess, in some areas that don't require the bridging study. When would you expect the first revenues to show up from that region?

A: That's hard to say. I mean, it could -- it's hard for us to say right now, and we haven't given any guidance on that. We're hoping that 2025 will be a year where there is revenues, although we do have a lot of -- we don't have a lot of control over what's going on, what Gloria is doing. We are obviously meeting with them on a regular basis. I would imagine that, that first sale should occur sometime in 2025.

Q: On Gamida Cell, obviously, the only other product that they're commercializing the omni-search (ph) product or do they have something else to be I think.

A: I think right now, that's what they have. I think they may have plans to bring in some additional products. But right now, they have omni-search of course, now they have APHEXDA.