BioLineRx Ltd. Q3 FY2025 earnings call

• Established JV with Hemispherian to develop GLIX1 for glioblastoma and other cancers, with plan to initiate Phase I/IIa trial in Q1 2026.
• APHEXDA had sales of $2.4 million in Q3 2025, generating $0.4 million royalty revenue.
• Motixafortide Phase I trial for sickle cell disease showed positive results, with abstract accepted for ASH Annual Meeting.
• Balance sheet strong with $25.2 million in cash and equivalents, sufficient to fund operations into first half of 2027.

APHEXDA generated sales of $2.4 million in Q3 2025, resulting in $0.4 million of royalty revenue to BioLineRx. The JV with Hemispherian for GLIX1 is a key segment, with Hemispherian contributing global rights of GLIX1 and BioLineRx responsible for clinical development. Cash and equivalents ended the third quarter at approximately $25.2 million, sufficient to fund operations into the first half of 2027.

• Cash and equivalents of $25.2 million sufficient to fund operating plan into first half of 2027.
• Plan to initiate GLIX1 Phase I/IIa glioblastoma trial in Q1 2026.
• Anticipate data from GLIX1 Phase I part of trial in first half of 2027, with periodic updates possible.

Q: Regarding PK and PD markers for GLIX1 trial, potential PD markers and manufacturing needs, and preclinical data readouts for additional tumor indications.

A: Ella Sorani responded that PK data will be extensive, PD markers from biopsies may be difficult early but could use surgeries if available; manufacturing with current CDMO is sufficient for Phase IIa; preclinical results expected to be presented at conferences next year.

Q: Medium-term target for APHEXDA market penetration and reasonable overall survival improvement for GBM to interest stakeholders.

A: Phil Serlin stated no guidance on APHEXDA market penetration as it's no longer BioLineRx's product; Ella Sorani mentioned for newly diagnosed GBM, improvement of ~2.5 months in median overall survival like temozolomide, and lower bar for recurrent GBM.

Q: How investments in JV will appear on financial statements.

A: Phil Serlin said BioLineRx consolidates the JV in financial statements, so JV expenses will be reflected in R&D expenses like direct operations