BioLineRx (BLRX) Study Update summary

Joint Venture and Asset Overview

• A joint venture was established with Hemispherian AS to develop GLIX1 (also referred to as GLYCS1), a first-in-class oral small molecule targeting DNA damage response in glioblastoma and other cancers, with Hemispherian contributing global rights and BioLineRx managing and funding development.

• The JV structure allows gradual investment, risk sharing, and access to Hemispherian's pipeline, with initial focus on GLIX1; ownership can increase from 40% to 70% as investment grows.

• No upfront payment was made; all funding is directed to development activities, and the JV has first look rights to other DNA repair-focused molecules in Hemispherian's pipeline.

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

• BioLineRx affirms a cash position of ~$28.2 million as of June 30, 2025, with a runway into the first half of 2027.

GLIX1 Mechanism, Preclinical Data, and Clinical Plan

• GLIX1 targets TET2, restoring DNA demethylation in cancer cells, leading to lethal DNA breaks while sparing normal cells, and shows strong efficacy in multiple cancer cell lines and glioblastoma models.

• Preclinical studies demonstrated potent anti-tumor activity, complete tumor growth prevention in GBM models, excellent blood-brain barrier penetration, and safety at high doses in GLP toxicology studies.

• GLIX1 is orally formulated, has robust manufacturing and stability profiles, and is effective in temozolomide-resistant glioblastoma cell lines.

• IND clearance was obtained from the FDA, and orphan drug designation was granted by both FDA and EMA.

• A phase 1/2a open-label trial is planned for Q1 2026, led by Northwestern University, with phase 1 focusing on safety, PK/PD, and preliminary efficacy in up to 30 recurrent GBM patients; data expected in H1 2027.

Market Opportunity and Intellectual Property

• Glioblastoma is a highly aggressive brain cancer with poor prognosis and limited treatment options; current standard of care benefits only a minority of patients.

• The addressable market is estimated at $2.5 billion in the U.S. and $1.3 billion in the EU5 by 2030, with some estimates exceeding $3.7 billion globally.

• Annual incidence is projected at 18,500 in the US and 13,400 in the EU5 by 2030.

• GLIX1 is protected by patents in the U.S., Europe, and other countries until at least 2040, with possible extensions up to five years; additional applications may extend protection to 2044.

• Additional patent applications cover use in broader cancer types and in combination with PARP inhibitors.