Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 60

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 60
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 numbers of long-term engrafting HSCs
(CD34+CD38-CD45RA-CD90+CD49f+) as compared to G-CSF.

Motixafortide also mobilizes cancer cells from the bone marrow,
detaching them from their survival signals and sensitizing them to chemotherapy. In addition, motixafortide has demonstrated a direct
anti-cancer effect by inducing apoptosis (cell death) and inhibiting proliferation in various cancer cell models (multiple myeloma, non-Hodgkin’s
lymphoma, leukemia, non-small-cell lung carcinoma, neuroblastoma and melanoma).

34

In the field of immuno-oncology, motixafortide mediates infiltration
of T-cells while reducing immune regulatory cells in the tumor microenvironment, or TME. In clinical studies, the combination of motixafortide
with immune checkpoint inhibitors, such as anti PD-1, has shown T-cell activation and a reduction in tumor cell numbers.

In September 2023, the FDA approved motixafortide in combination
with G-CSF to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients
with multiple myeloma. Following this approval, we commenced commercialization of motixafortide in the U. S. independently in order to
accelerate its availability to patients and to maximize the value of this innovative therapeutic candidate.

The FDA approval of APHEXDA was based on results from the 2-part,
Phase 3 GENESIS trial, a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of APHEXDA plus G-CSF compared
to placebo plus G-CSF, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients. Top-line
results announced in May 2021 showed highly statistically significant evidence across all primary and secondary endpoints favoring motixafortide
in combination with G-CSF (p<0.0001). In addition, the combination was found to be safe and well tolerated.

During 2023, we completed the build-out of the infrastructure for
commercial operations in the U. S. designed to support the commercialization of APHEXDA and launched the product in the U. S. In November
2024, we entered into the Ayrmid License Agreement with Ayrmid, pursuant to which we granted to Ayrmid an exclusive, transferable, royalty