BioLineRx (NASDAQ:BLRX) reported second-quarter 2026 results while highlighting continued enrollment in its early-stage GLIX1 study for glioblastoma and progress in preclinical work evaluating the drug candidate in combination with PARP inhibitors for ovarian cancer.
Chief Executive Officer Phil Serlin said the company initiated its Phase I/IIa trial of GLIX1 in glioblastoma and other high-grade gliomas in March, with the first patient dosed in April at NYU Langone Health. Northwestern University and Moffitt Cancer Center have also enrolled patients in the Phase I portion of the study.
GLIX1 Trial and Preclinical Findings
GLIX1 is an oral small molecule designed to activate the TET2 enzyme and induce tumor DNA damage. BioLineRx selected glioblastoma as the initial indication, citing suppressed TET2 activity in the disease and the need for additional treatment options.
The Phase I segment is expected to recruit up to 30 patients with recurrent or progressive glioblastoma and other high-grade gliomas. The company aims to establish a maximum tolerated dose or recommended dose using safety, pharmacokinetic, pharmacodynamic and preliminary efficacy data. BioLineRx continues to expect Phase I data in the first half of 2027.
Serlin said the planned Phase IIa expansion could include cohorts in newly diagnosed or recurrent glioblastoma and other cancers, potentially in combination with standard therapies such as PARP inhibitors.
BioLineRx plans to present GLIX1 data at the European Association of Neuro-Oncology 2026 Conference and the Society for Neuro-Oncology 2026 Annual Meeting. The company previously reported preclinical findings in multiple orthotopic glioblastoma models, including a temozolomide-resistant patient-derived xenograft model.
In three orthotopic cell-derived xenograft glioblastoma models, GLIX1 showed tumor-growth inhibition and survival benefit across tested doses, with greater benefit at higher doses, Serlin said. In the temozolomide-resistant patient-derived xenograft model, the company said GLIX1 demonstrated an antitumor effect while temozolomide showed no effect.
Ovarian Cancer Combination Work
In July, BioLineRx reported preclinical data showing synergy between GLIX1 and the PARP inhibitor olaparib in a patient-derived xenograft model of homologous recombination-proficient ovarian cancer. Serlin said the combination of low-dose GLIX1 and low-dose olaparib showed better efficacy than the control arm and either monotherapy, despite using lower doses of both agents.
The combination achieved tumor reduction comparable with cisplatin in that study, according to the company. BioLineRx plans to present data on GLIX1 and PARP inhibitor synergy across homologous recombination-proficient ovarian cancer lines, as well as the patient-derived xenograft model, at the ESMO Annual Conference in Madrid in October.
Chief Development Officer Ella Sorani said it was too early to determine the best clinical-development strategy for the combination. She noted that PARP inhibitors are currently approved as maintenance therapy following standard treatment and said BioLineRx is discussing potential development paths with ovarian cancer key opinion leaders.
Serlin added that the company has begun discussions with several PARP inhibitor developers regarding potential collaborations involving GLIX1.
Pancreatic Cancer and APHEXDA
BioLineRx retained rights to motixafortide in pancreatic ductal adenocarcinoma under its out-licensing agreement with Ayrmid. Columbia University, with support from Regeneron and BioLineRx, is conducting the randomized Phase IIb CheMo4METPANC study of motixafortide combined with Regeneron’s PD-1 inhibitor cemiplimab, gemcitabine and nab-paclitaxel.
Enrollment in the study remains on track, Serlin said. A pre-specified interim futility analysis is expected later this year, when 40% of progression-free survival events have been observed.
Asked whether a recent approval for Revolution Medicines’ daraxonrasib could alter BioLineRx’s approach to pancreatic cancer, Serlin said the company recognizes that the treatment landscape could change but still believes CXCR4 inhibition with motixafortide may have a role. He said BioLineRx will assess the interim analysis results before determining the best next steps.
Ayrmid generated $1.6 million in second-quarter 2026 sales of APHEXDA, resulting in $0.3 million in royalty revenue to BioLineRx. Serlin said the company could not provide detailed guidance on Ayrmid’s commercial activity, but said adoption at transplant centers takes time because it requires changes to treatment practices.
Financial Results and Cash Position
Chief Financial Officer Mali Zeevi reported second-quarter revenue of $0.3 million, unchanged from the prior-year period and primarily reflecting royalties on APHEXDA sales.
- Research and development expense was $2.9 million, compared with $2.3 million a year earlier, primarily due to the GLIX1 program, partly offset by lower motixafortide spending.
- General and administrative expense was $0.9 million, compared with $0.2 million in the prior-year quarter. The 2025 figure included a reversal of a $0.8 million doubtful-account provision after BioLineRx received an overdue milestone payment from Gloria Biosciences.
- Non-operating expense was $0.7 million, compared with $1.9 million in the prior-year period, primarily related to fair-value adjustments of warrant liabilities.
- Net loss was $4.3 million, compared with a $3.9 million loss in the second quarter of 2025.
BioLineRx ended June with $13.1 million in cash equivalents and short-term bank deposits, which management said should fund operations as currently planned into the first half of 2027. Subsequent to quarter-end, the company announced a $3.75 million registered direct offering that it expected to close later on the day of the call.
About BioLineRx (NASDAQ:BLRX)
BioLineRx (NASDAQ: BLRX) is a clinical-stage biopharmaceutical company that discovers and develops novel small-molecule therapies to address unmet medical needs. The company focuses on identifying promising drug candidates through licensing and collaboration agreements with academic institutions and biotech innovators, then advancing these candidates through preclinical and clinical development stages. BioLineRx’s pipeline spans oncology, immunology and inflammatory diseases, central nervous system disorders and pain management.
Among its clinical programs, BioLineRx is advancing targeted cancer therapies designed to improve outcomes for patients with difficult-to-treat tumors.
