Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 28

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 28
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, if approved.

Further, the Centers for Medicare and Medicaid Services, or CMS,
frequently change product descriptors, coverage policies, product and service codes, payment methodologies and reimbursement values. The
IRA will modify 60 drugs and biologics through negotiation of a fair maximum pricing for CMS. Third-party payors often follow Medicare
coverage policy and payment limitations in setting their own reimbursement rates, and both CMS and other third-party payors may have sufficient
market power to demand significant price reductions.

Our business has a substantial
risk of clinical trial and product liability claims. If we are unable to obtain and maintain appropriate levels of insurance, a claim
could adversely affect our business.

Our business exposes us to significant potential clinical trial
and product liability risks that are inherent in the development, manufacturing and sales and marketing of human therapeutic products.
Claims could be made against us based on the use of our therapeutic candidates in clinical trials and in marketed products. In addition,
we have a cyber insurance policy with a coverage amount of $5.0 million per each claim and in the aggregate However, our insurance may
not provide adequate coverage against potential liabilities. Furthermore, clinical trial and product liability insurance is becoming increasingly
expensive. As a result, we may be unable to maintain current amounts of insurance coverage or to obtain additional or sufficient insurance
at a reasonable cost to protect against losses that could have a material adverse effect on us. If a claim is brought against us, we might
be required to pay legal and other expenses to defend the claim, as well as damage awards beyond the coverage of our insurance policies
resulting from a claim brought successfully against us. Furthermore, whether or not we are ultimately successful in defending any claims,
we might be required to direct significant financial and managerial resources to such defense, and adverse publicity is likely to result.

Significant disruptions
of our information technology systems or breaches of our data security could adversely affect our business.

A significant invasion, interruption, destruction or breakdown
of our information technology systems and/or infrastructure by persons with authorized or unauthorized access could negatively impact
our business and operations. We could experience business interruption, information theft and/or reputational damage from cyber-attacks
or cyber-intrusions over the Internet, computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical
failures, and attachments to emails. Any of the foregoing may compromise our systems and lead to data leakage either internally or at
our third-party providers. The risk of a security breach or disruption, particularly through cyber