Holly May: Can I add on to that? I just want to be clear about the opportunity. This would be for ex-vivo type of approaches or those approaches — those gene therapy approaches which require CD34+ stem cells it would not be applicable for say a gene therapy, like an AAV gene therapy. So in looking at the gene therapy opportunities, our focus obviously would be on those that require stem cells in order to complete the gene therapy. That would be most definitely the focus as is with sickle cell as Phil just spoke of.
Phil Serlin: John, did that answer your question? Is there anything else?
John Vandermosten: No, I appreciate the answers, Phil. Thank you.
Operator: The next question is from Joe Pantginis of H. C. Wainwright.
Unidentified Analyst : This is [Lander] on for Joe. So regarding the Phase 2 study in pancreatic cancer in China with Gloria, I wonder if you could provide some color on the preparations. Do you anticipate any difficulties with the Chinese agency or recruitment or site activation of the trial? And also are there plans to expand to additional Asian territories besides Macau and Singapore?
Ella Sorani: Hi, this is Ella. With regards to the PDAC study in China — we are Gloria is planning to submit it to the regulatory authorities and hopefully the study can be initiated early by the end of this year or by the latest early next year that’s with regards to the PDAC. I think the question you asked of expanding in additional territories, you’re relating to the PDAC, was this related to PDAC or stem cell mobilization?
Unidentified Analyst : Maybe both. It’s Gloria. Are you planning on any agreement with Gloria to expand to additional territories beside China?
Phil Serlin: Yes. So maybe I can take that. So first of all, in PDAC, I also want to answer the second part of your question. We anticipate Gloria being able to recruit the patients quite quickly. As I mentioned in the prepared remarks, they were able to bring a drug in two indications for approval in China within four years, which is on Western terms very, very significant and very quick. And so I think their ability to recruit the patients for the Phase 2b study in PDAC is quite significant and some of the institutions there are quite large in comparison to institutions in the West. As far as where they’re going with the, for in other territories, I guess we can separate that into stem cell mobilization and PDAC. So with regard to stem cell mobilization, there are a number of territories because we have FDA approval, there are a number of territories in the Asia region, mostly in southeast Asia, like Singapore, some areas of China I think Macau, et cetera that have a sort of an early access type of program where you can use a drug, a U.S.-label drug based on FDA approval and sell into the territory to various hospitals, et cetera, et cetera.
And so they are working very diligently to try to start the commercialization very quickly in these smaller areas. But as far as the larger areas of the territory, for example, China, Japan and Korea, our assessment and their assessment as well is that there will probably be a bridging study, one or more bridging studies required that include Asian patients in order to get regulatory approval for stem cell mobilization. So that’s regarding stem cell mobilization. With regard to pancreatic cancer because pancreatic cancer has no approval anywhere, the pathway is obviously much longer. They’re still, they’re going to be starting the trial in China and I think that right now that’s sort of the main focus in pancreatic cancer is to get the trial up and initiated in China and see what the results are and then based on that expand perhaps into other areas.
We would be thinking as well about at some time down the road based on this data, interesting a partner, getting a partner interested in a large registrational Phase 2, 3 global trial but that’s a little bit down the road. But that’s sort of the pathway right now for Gloria in Asia. I hope that answers your question.
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 two hours after the conference. In the U.S., please call 1-888-295-2634. In Israel, please call 039-255-0904. Internationally, please call 9723-9255-904. Mr. Serlin, would you like to make your concluding statement?
Phil Serlin : Yes. Thank you, operator. In closing, we are progressing through 2024 with significant momentum both with our ongoing commercial ramp of APHEXDA as well as the advancement of our development programs in pancreatic cancer and sickle cell disease. I am excited for what we are poised to accomplish over the remainder of year and next. Thank you all very much for your continued interest in BioLineRx. We look forward to providing you our next comprehensive quarterly May. Be safe, and have a great day.
Operator: Thank you. This concludes the BioLineRx fourth quarter 2023 conference call. Thank you for your participation. You may go ahead and disconnect.
