BioLineRx's (BLRX) BL-8040 Better Positioned as SOC Alternate in SC Mobilization - Roth Capital

Roth Capital reaffirms its Buy rating and $10.50 price target on BioLineRx (Nasdaq: BLRX) following topline data from the Phase I study of BL-8040 for stem cell (SC) mobilization in healthy volunteers, which showed that BL-8040 met all safety and efficacy endpoints.

Analyst Joseph Pantginis commented, We believe these data represent important proof of concept demonstrating BL-8040's efficacy in mobilizing SC as well as its differentiating characteristics from current SC mobilization procedure with G-CSF and Mozobil. Current procedures require a much more elaborate treatment and collection process, including up to five days of dosing with G-CSF and up to three days of collection through apheresis. This study showed that a single administration of single-agent BL-8040 was sufficient to allow a one day collection of SC through apheresis in all patients, four hours following BL-8040 administration. Moreover, the study found that the SC yield surpassed that needed for transplants.

We believe this study shows that BL-8040 offers an appealing alternative to current treatments used to mobilize stem cells out of bone marrow (for both allogeneic and autologous transplants). The company will present this study at EHA in June 2015.

BLRX will now analyze and discuss data with FDA and plans on initiating a Phase II in 1H16. Recall that data from the Phase II study of BL-8040 in r/r AML is expected in 2H15. Additionally, three new studies with BL-8040 are expected in 2Q15 in AML consolidation treatment, FLT3-ITD AML patients and in hMDS and aplastic anemia.

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BioLineRx closed at $2.28 yesterday.

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