BLRX

Business Context and Reporting Period

Company: BioLineRx Ltd.
Filing Type: Annual Report on Form 20-F
Reporting Period: Fiscal year ended December 31, 2025
Business Overview: BioLineRx is a biopharmaceutical company focused on oncology and rare diseases. Its primary asset is APHEXDA (motixafortide), approved for stem cell mobilization in multiple myeloma. In late 2024, the company out-licensed global rights (excluding Asia and solid tumors) to Ayrmid Pharma Ltd., shutting down its independent U.S. commercial operations to reduce cash burn. In September 2025, the company entered a collaboration with Hemispherian AS to develop GLIX1, a novel oral small molecule for glioblastoma, via a new subsidiary, Tetragon Biosciences Ltd.

Key Financial Metrics (Year Ended Dec 31, 2025)

Note: Revenue in 2025 consists primarily of royalties from Ayrmid. The 2024 revenue included significant one-time upfront and milestone payments from licensing deals with Gloria and Ayrmid.

Material Changes vs. Prior Period

• Revenue Decline: Revenues decreased by 96% ($27.7 million) compared to 2024. This reflects the absence of large upfront licensing payments recorded in 2024 and the cessation of direct product sales in the U.S. following the Ayrmid out-licensing.
• Expense Reduction:
  • Sales & Marketing: Dropped to $0 in 2025 from $23.6 million in 2024 due to the shutdown of U.S. commercial operations.
  • General & Administrative: Decreased by 50% to $3.1 million, driven by headcount reductions and the reversal of a doubtful accounts provision.
  • R&D: Decreased slightly to $8.1 million, offset by costs related to the new GLIX1 project.
• Non-Operating Income: Net non-operating income was $8.1 million in 2025, primarily driven by fair value adjustments on warrant liabilities due to share price fluctuations.
• Debt Restructuring: In November 2024, the company amended its BlackRock loan agreement, making a $16.5 million partial repayment and restructuring the remaining balance over three years.

Guidance, Outlook, and Risks

Going Concern: Management and the independent auditor have expressed substantial doubt about the company's ability to continue as a going concern due to recurring losses and negative cash flows. However, management believes existing cash resources ($20.9 million) and anticipated royalties/milestones will fund operations into the first half of 2027.

Outlook:

• GLIX1: IND cleared by FDA in August 2025; Phase 1/2 study expected to initiate in Q1 2026.
• Motixafortide (Solid Tumors): Retained rights for solid tumors (e.g., pancreatic cancer). A randomized Phase 2b trial is ongoing with an interim futility analysis planned for 2026.
• Liquidity: Future funding may require additional equity/debt offerings or further out-licensing.

Key Risks:

• Geopolitical Instability: Ongoing conflicts in Israel and the Middle East pose risks to operations, supply chains, and employee safety.
• Collaborator Dependence: Success relies heavily on Ayrmid and Gloria to commercialize motixafortide and generate royalties.
• Debt Covenants: Default on the BlackRock loan could result in forfeiture of assets.
• Regulatory/Clinical Failure: Risks associated with the development of GLIX1 and motixafortide in solid tumors.

Investor Verification Checklist

• Cash Runway: Verify if the $20.9 million cash balance is sufficient to cover the $5 million investment commitment to Tetragon (GLIX1) and ongoing operational costs through mid-2027.
• Debt Obligations: Confirm the repayment schedule for the BlackRock loan and the impact of the 10% milestone payment clawback provision.
• Collaborator Performance: Monitor Ayrmid's commercialization progress of APHEXDA to ensure expected royalty streams materialize.
• Geopolitical Exposure: Assess the impact of ongoing military conflicts in Israel on the company's ability to conduct R&D and retain key personnel.
• Warrant Liability: Review the volatility of the warrant liability on the balance sheet, which significantly impacts non-operating income/loss.