GLIX1 First-in-Human Trial Initiation and Dosing
Phase I/IIa trial for GLIX1 in glioblastoma (GBM) initiated; first patient dosed at NYU Langone. Trial Phase I expects up to 30 recurrent GBM/high-grade glioma patients to determine MTD/RDose based on safety, PK/PD and preliminary efficacy. Periodic updates expected in H2 2026, full dose-escalation results anticipated in 2027.
Strong Preclinical Efficacy and Differentiators for GLIX1
New preclinical data: robust, dose-dependent tumor growth inhibition and survival benefit in two orthotopic CDx GBM models; robust antitumor effect in a temozolomide-resistant PDX where temozolomide showed no effect. GLIX1 crosses the blood-brain barrier and restores TET2 activity, supporting monotherapy and combinations (notably with PARP inhibitors) and two abstracts accepted for ASCO online publication.
Commercial Traction for APHEXDA via Partner Ayrmid
Ayrmid reported APHEXDA sales of $2.5M in Q1 2026 vs $1.4M in Q1 2025, an increase of approximately 78.6%, resulting in $0.5M of royalty revenue to BioLineRx.
Revenue Increase Driven by Royalties
BioLineRx revenues rose to $0.5M for Q1 2026 from $0.3M in Q1 2025 (an increase of ~$0.2M, or ~66.7%), reflecting higher royalties from APHEXDA commercialization.
Ongoing Motixafortide Clinical Activity in PDAC
Columbia University–led randomized Phase IIb CheMo4METPANC trial (motixafortide + cemiplimab + gemcitabine/nab-paclitaxel) is enrolling and tracking well; a prespecified interim futility analysis is planned when 40% of PFS events are observed (anticipated later this year).
Strategic Rights and Development Opportunities
BioLineRx retained PDAC rights to motixafortide and benefits from Ayrmid's broader development/commercial rights (excluding solid tumors and non-Asia territories). Ayrmid is also developing motixafortide in sickle cell disease, representing potential future revenue expansion.
Cash Position
Cash and equivalents of $17.4M at quarter end, which the company states is sufficient to fund the operating plan into the first half of 2027.