BioLineRx Ltd. (NASDAQ:BLRX) Q4 2022 Earnings Call Transcript

We just know that there is a high demand in those sort of therapeutic areas.

John Vandermosten: Okay. And it seems like with the success of this has been done so far, there might be a lot of demand to perhaps use this in some investigator-led studies? Have you seen demand like that?

Philip Serlin: We have — we can’t disclose anything right now. We’ve only disclosed the Washington University but we are speaking with other potential sites and the hospitals and universities about some other things as well in gene therapy, yes.

John Vandermosten: Great. And I had a couple of questions on AGI-134. Do you expect any kind of expedited treatment as we move along for this?

Philip Serlin: Can you — development, is that what you mean?

John Vandermosten: Expedited treatment from the FDA regulatory agencies in terms of some kind of quicker perhaps approval on Phase II data or something like that or the expedited treatment in terms of accelerated review or closer contact with the FDA?

Philip Serlin: Yes. So I mean, we’re still — this is still quite early. We just completed a first-in-man study. We had some very interesting data from the study. We are looking at what our next steps are throughout 2023. So I think in this way, it might be a little early to ask from the FDA for any type of expedited program. I think the next step would theoretically be a Phase II of some sort. And again, we just finished our first-in-man study. So I think it’s probably too early. Ella, would you like to add anything to that?

Ella Sorani: No.

John Vandermosten: Okay, great. And then, a little bit more specific question on 134. I was reading through the press release and it said that some of the patients have been on checkpoint inhibitor therapy. Was that monotherapy or was that combination checkpoint therapy?

Ella Sorani: So, this is Ella. The therapy in our study with monotherapy with the AGI, just previous treatment, some of them were previously treated prior to participating in the study were treated with the checkpoint inhibitor. So it was no treatment during our study. It was previously treated. They’re based on checkpoint inhibitor and then were treated with our drug.

John Vandermosten: Right. So their checkpoint therapy that they had prior to AGI-134, is that a combination with another immunotherapy or another — or some other kind of therapy? Or was it just checkpoint inhibitor therapy alone prior to going into your study?

Philip Serlin: It was probably a combination, John but we don’t have that data in front of us. That’s a very specific question at this point. It could be both, it’s hard to say. But I mean — and we haven’t really disclosed that data in any event.

John Vandermosten: Okay. Just checkpoint there be a lot more efficacious when it’s used in combination sometimes, have you used it alone or…

Operator: There are no further questions at this time. 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 2 hours after the conference. In the U.S., please call 1-888-295-2634. In Israel, please call 0392-55904. Internationally, please call 972-3-9255-904. Mr. Serlin, would you like to make your concluding statements?