Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 7

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 7
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, which would have a material adverse effect on our business, financial condition, prospects
or results of operations.

Management has concluded
that there is substantial doubt about our ability to continue as a going concern, which could prevent us from obtaining new financing
on reasonable terms or at all.

We have incurred significant losses and negative cash flows from
operations and have an accumulated deficit that raises substantial doubt about our ability to continue as a going concern. Our audited
consolidated financial statements for the year ended December 31, 2024 were prepared under the assumption that we would continue our operations
as a going concern. Our independent registered public accounting firm has included a “going concern” explanatory paragraph
in its report on our financial statements for the year ended December 31, 2024. If we are unable to improve our liquidity position, by,
among other things, raising capital through public or private offerings or reducing our expenses, we may exhaust our cash resources and
will be unable to continue our operations. If we cannot continue as a viable entity, our shareholders would likely lose most or all of
their investment in us.

Risks Related to Our Business and Regulatory Matters

We have earned limited commercialization
revenues to date. We may never achieve profitability.

We are a biopharmaceutical company pursuing life-changing therapies in oncology and
rare diseases. To date, we have generated only limited revenues from commercialization. We have FDA regulatory approval in the United
States for APHEXDA (motixafortide). In October 2023, we out-licensed to Gloria the rights to motixafortide for all indications in substantially
all of Asia, and in November 2024, we out-licensed to Ayrmid the global rights (other than in Asia) to motixafortide for all indications,
other than solid tumors. As a result of the November 2024 transaction, we shut down our independent commercialization activities in the
United States and refocused our operations on development activities in Israel in the fields of oncology and rare diseases, at a significantly
reduced annual cash burn rate.

Our ability to generate revenues from commercialization and achieve
profitability will be dependent on the ability of the licensees under the Gloria License Agreement (as defined below) and the Ayrmid License
Agreement to successfully commercialize the licensed products and the ability of any future partners or licenses to successfully commercialize
any other product candidates that we may develop, in-license or acquire in the future