BioLineRx Ltd. Q1 FY2025 earnings call

• Announced a transformational exclusive out-licensing agreement with Ayrmid Pharma for APHEXDA, receiving upfront payment, milestones, and royalties. APHEXDA returned to growth in Q1 2025 with sales of $1.4 million and $0.3 million in royalties.
• Focused on evaluating early clinical and late preclinical stage therapeutic assets in oncology and rare disease. Conducting due diligence on potential candidates, with development funded by milestones and royalties from license agreements.
• Continues to support development of motixafortide in pancreatic cancer. The CheMo4METPANC Phase 2 trial is enrolling patients, with an abstract from the pilot phase accepted for ASCO 2025 presentation showing promising results including high partial response and disease control rates, and increased CD8 positive T cell density in tumors.
• Streamlined organization and strengthened balance sheet, positioning to advance motixafortide in solid tumor indications and evaluate/in-license additional assets.

The main segment is APHEXDA. In Q1 2025, APHEXDA generated sales of $1.4 million, resulting in $0.3 million of royalty revenues to BioLineRx. Total revenues for the quarter ended March 31, 2025 were $0.3 million. Research and development expenses were $1.6 million, down from $2.5 million in the comparable period in 2024. Sales and marketing expenses were $0, compared to $6.3 million in 2024. Net income was $5.1 million, up from a net loss of $0.7 million in 2024.

• Cash runway projected to fund operations through the second half of 2026.
• Anticipate APHEXDA to continue growing, with potential for milestone payments and royalties from license agreements.
• Plan to evaluate and in-license additional oncology and rare disease assets, aiming to expand pipeline.

• Uncertainties associated with forward-looking statements; actual results may differ materially.
• Risks related to clinical trial outcomes and regulatory approvals for potential assets.
• Dependencies on license partners' success in commercializing APHEXDA and achieving milestones.

Q: Can you provide color on the cash runway and if projected development costs are offset by milestones and royalties?

A: Yes, the cash runway includes projected development costs and is offset by potential milestones and royalties.

Q: Have the costs from the November restructuring worked their way through the P&L?

A: Absolutely, those costs were fully accrued by the end of 2024 with no more anticipated costs in 2025.

Q: Any anecdotes on excitement for CheMo4METPANC study sites?

A: Sites are excited to join, with data from the pilot phase showing exceptional results like complete response in some patients.

Q: Communication strategy for CheMo4METPANC interim analysis and regulatory strategy?

A: Aligned with Columbia University's communication strategy; PFS is the primary endpoint, and regulatory approval based on PFS alone is unlikely.

Q: Expectations for APHEXDA royalty proportion and milestones?

A: Royalties are tiered, with potential for milestone payments up to $87 million, depending on commercial performance.

Q: Principles for searching new assets?

A: Looking for programs with short clinical development pathways, lean programs to reach value-creating events, and focusing on modest indications with short pathways.