BioLineRx (BLRX) Study Update summary

Joint Venture Formation and Strategic Focus

• Entered a joint venture with Hemispherian AS to develop GLIX1, a first-in-class oral small molecule targeting DNA damage response in glioblastoma and other cancers.

• Hemispherian contributes global rights to GLIX1; BioLineRx manages and funds development, with ownership increasing as investment grows.

• No upfront payment; all funding directed to development activities, and the JV has first look at other Hemispherian pipeline molecules.

• Hemispherian initially holds 60% of the JV, with BioLineRx's stake potentially increasing to 70% with further investment.

• The JV structure allows gradual investment, risk sharing, and maximizes synergies between the partners.

GLIX1 Mechanism, Preclinical Data, and Intellectual Property

• GLIX1 targets TET2, restoring DNA demethylation and inducing double-stranded DNA breaks selectively in cancer cells while sparing healthy tissue.

• Demonstrated potent anti-tumor activity, excellent blood-brain barrier penetration, and efficacy in temozolomide-resistant glioblastoma cell lines.

• Preclinical studies showed complete tumor growth prevention, improved survival in mouse models, and strong efficacy in multiple cancer cell lines.

• GLP toxicology studies in rats and dogs showed safety at high doses; Orphan Drug Designation granted by FDA and EMA.

• GLIX1 is covered by patents in the US, Europe, and other countries, valid until at least 2040, with possible extensions.

Clinical Development Plan and Trial Design

• IND cleared by FDA; phase I/IIA trial planned to start in Q1 2026, led by top investigators at Northwestern University.

• Phase I will enroll up to 30 recurrent GBM patients to determine maximum tolerated or recommended dose based on safety, PK, PD, and preliminary efficacy.

• Phase IIA will include cohorts for GLIX1 monotherapy in recurrent GBM, GLIX1 plus standard of care in newly diagnosed GBM, and GLIX1 with PARP inhibitors in other solid tumors.

• Open-label design allows ongoing data review and timely updates; data from phase I expected in the first half of 2027.

• Manufacturing is established with sufficient drug product for trial initiation and robust stability profile.