Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 12

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 12
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 impose additional testing requirements for our therapeutic
candidates.

We and our licensees may
not obtain additional marketing approvals for motixafortide or initial approval for any other therapeutic candidates we may develop in
the future.

We and our licensees may not obtain additional marketing approvals
for motixafortide or any other therapeutic candidate that we may develop in the future. It is possible that the FDA or comparable foreign
regulatory agencies may refuse to accept for substantive review any future application that we or a licensee may submit to market and
sell our therapeutic candidates, or that any such agency may conclude after review of our or our licensee’s data that such application
is insufficient to obtain marketing approval of our therapeutic candidate.

If the FDA or other comparable foreign regulatory agency does not
accept or approve any future application to market and sell any therapeutic candidate, such regulators may require that we conduct additional
clinical trials, preclinical studies or manufacturing validation studies and submit that data before they will reconsider our application.
Depending on the extent of these or any other required trials or studies, approval of any application that we submit may be delayed by
several years, or may require us or our licensee to expend more resources than we or they have available. It is also possible that additional
trials or studies, if performed and completed, may not be considered sufficient by the FDA or other foreign regulatory agency to approve
our applications for marketing and commercialization.

Any delay in obtaining, or an inability to obtain, marketing approvals
would prevent us or our licensees from commercializing motixafortide in other jurisdictions and indications or any other therapeutic candidate
that we may develop in the future and generating revenues. If any of these outcomes occur, we would not be eligible for certain milestone
and royalty revenue under our license agreements, our licensees could terminate our license agreements and we may be forced to abandon
our development efforts, any of which could significantly harm our business.

8

Clinical trials involve
a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial
results.

Clinical trials are expensive and complex, can take many years
and have uncertain outcomes. We cannot necessarily predict whether we or any licensee will encounter problems with any of the completed,
ongoing or planned clinical trials that will cause us, any licensee or regulatory authorities to delay or suspend clinical trials, or
to delay the analysis of data from completed or ongoing clinical trials. In addition, because some of our clinical trials are investigator-initiated
st