Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 16

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 16
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  a licensee could move forward with a competing                                                                        

  out-licensing arrangements are often terminated                                                                                
  or allowed to expire, which would delay the development and may increase the development costs of our therapeutic candidates.  
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Under the Gloria License Agreement, Gloria is late in the payment
of $2.4 million to us for the achievement of a specific milestone under the Gloria License Agreement and for certain product supply that
was due during 2024. In addition, the planned studies of motixafortide in China under the Gloria License Agreement are currently not advancing
according to schedule and it is unclear when such studies will be initiated, if at all. There can be no assurance that Gloria will meet
its payment obligations or any other obligations under the Gloria License Agreement.

If we or any licensee breaches or terminates its agreement with
us, or if any licensee otherwise fails to conduct its development and commercialization activities in a timely manner or there is a dispute
about their obligations, we may need to seek other licensees, or we may have to develop our own internal sales and marketing capability.

Our dependence on a licensee’s experience and the rights
of a licensee will limit our flexibility in considering alternative out-licensing arrangements for any therapeutic candidate. Any failure
to successfully develop these arrangements or failure by a licensee to successfully develop or commercialize any therapeutic candidate
in a competitive and timely manner will have a material adverse effect on the commercialization of any therapeutic candidate.

We depend on our ability
to identify and in-license technologies and therapeutic candidates.

We employ a number of methods to identify therapeutic candidates
that we believe are likely to achieve commercial success. In certain instances, disease-specific third-party advisors evaluate therapeutic
candidates as we deem necessary. However, there can be no assurance that our internal research efforts or our screening system will accurately
or consistently select among various therapeutic candidates those that have the highest likelihood to achieve, and that ultimately achieve,
commercial success. As a result, we may spend substantial resources developing therapeutic candidates that will not achieve commercial
success, and we may not advance those therapeutic candidates with the greatest potential for commercial success. For example, we
recently determined to terminate development of AGI-134 and provided notice of our intent to terminate the Agalimmune Development Agreement
(as defined below) effective March 15, 2024 and intend to either transfer ownership of our subsidiary Agalimmune Ltd., or Agalimmune