BioLineRx Ltd. Q4 FY2025 earnings call

1. GLICS-1: Highly innovative molecule for glioblastoma and other cancers. On track to initiate Phase 1-2A glioblastoma trial by end of current month. FDA and EMA orphan drug designations. Pending U.S. patent for use in 90% of cancers. Preclinical results in other cancers. 2. Pancreatic cancer (PDAC): Chemo4MedPANC trial enrollment accelerated. Pre-specified interim futility analysis planned for 2025. 3. Sickle cell disease: Phase 1 trial for metixiportide in sickle cell disease concluded with positive results. Second study ongoing. 4. Legal matter: Arbitration award in favor of BioLine Rx, removing financial overhang.

In 2025, Fexted generated sales of $6.5 million, resulting in $1.2 million of royalty revenue to BioLineRx. Revenues for the year were $1.2 million, down from $28.9 million in 2024. Research and development expenses in 2025 were $8.1 million vs $9.2 million in 2024, due to lower MOTIX expenses and initiation of GLIX-1 project. General and administrative expenses were $3.1 million vs $6.3 million in 2024, due to reversal of doubtful accounts provision and headcount decrease.

1. GLICS-1 Phase 1-2A glioblastoma trial to initiate by end of current month, with data from phase one expected in first half of next year. 2. Chemo4MedPANC trial's interim futility analysis planned for 2025. 3. Gloria's bridging study in stem cell mobilization expected to have data sometime next year.

1. Uncertainty in clinical trial outcomes for GLICS-1 and other programs. 2. Dependence on license agreements and milestone payments from partners. 3. Financial difficulties of partners like Gloria impacting development timelines.

Q: About upcoming Phase I study in GBM, potential for interim overall response data?

A: Major objective is safety and recommended dose, not primarily efficacy. Secondary look at efficacy but not major objective.

Q: Enthusiasm from PIs for GLICS-1 trial?

A: High enthusiasm due to novel mechanism and preclinical results.

Q: Status of Gloria's phase 3 bridging trial and PDAC trial?

A: Gloria working on bridging study in stem cell mobilization, PDAC solid tumor indications still in discussion.

Q: Blood brain barrier penetration measurement in GLICS-1 study?

A: Biopsies possible but not mandatory, no guarantee of measurement.

Q: Airbit's guidance on Effects sales?

A: Airbit is private, hasn't provided long-term guidance to BioLine Rx yet