BioLineRx (NASDAQ:BLRX) reported first-quarter 2026 results and highlighted progress in its oncology pipeline, led by the start of a first-in-human clinical trial for GLIX1 in glioblastoma and continued development of motixafortide in pancreatic cancer.
Chief Executive Officer Phil Serlin said the company dosed the first patient in March in a Phase I/IIa trial of GLIX1, an oral small molecule being developed for glioblastoma, or GBM, and other cancers. The first patient was treated at NYU Langone Health under the supervision of Dr. Alexandra Miller, Chief of Neuro-Oncology and Co-Director of the Brain and Spine Tumor Center at Perlmutter Cancer Center.
GLIX1 Trial Begins in Glioblastoma
The Phase I portion of the trial is expected to recruit up to 30 patients with recurrent GBM and other high-grade gliomas. Serlin said the goal is to establish a maximum tolerated dose and/or recommended dose based on safety, pharmacokinetics/pharmacodynamics and preliminary efficacy.
BioLineRx expects to provide periodic updates on the trial during the second half of 2026, with full dose-escalation results anticipated in 2027. The Phase IIa expansion portion is planned to include additional indications, including newly diagnosed GBM and select cancers, with GLIX1 tested as monotherapy or in combination with standard of care, including PARP inhibitors.
Serlin described GLIX1 as an oral small molecule with a novel mechanism of action intended to restore TET2 activity and selectively target DNA damage repair in cancer cells. He said glioblastoma was selected as the first indication because of low TET2 activity in the disease and because of the significant unmet need for new treatments.
“GLIX1 has demonstrated its ability to cross the blood-brain barrier, which is a highly significant differentiator for treating GBM,” Serlin said.
The company also discussed new preclinical data showing that GLIX1 achieved dose-dependent tumor growth inhibition and survival benefit in several studies using two orthotopic cell-derived xenograft models in GBM. In a subcutaneous temozolomide-resistant patient-derived xenograft model, Serlin said GLIX1 demonstrated a robust anti-tumor effect while temozolomide showed no effect.
Serlin said BioLineRx has two GLIX1 abstracts accepted for online publication at the ASCO meeting, including data supporting the molecule’s mechanism of action and the rationale for combining GLIX1 with PARP inhibitors.
Management Sees Limited Enrollment Competition in Recurrent GBM
During the question-and-answer portion of the call, Justin Walsh of JonesTrading asked about the GBM development landscape and whether patient enrollment could be competitive. Serlin said the field remains “sort of a wide open area,” adding that while some drugs are in development, “nothing is really working at this point” in therapeutics.
Chief Development Officer Ella Sorani said the current study is focused on recurrent and progressive GBM patients, a population where the company does not see meaningful competition for recruitment.
“For this patient population, currently there is no real competition in terms of recruitment,” Sorani said.
In response to a question from H.C. Wainwright about site activation and early safety observations, Serlin said NYU is open and recruiting and that the company is working with the other sites, which he said will be open “very shortly.” He said BioLineRx was not yet providing initial safety observations but expects to give periodic updates rather than wait until the end of the trial.
Motixafortide Development Continues in Pancreatic Cancer
Serlin said BioLineRx continues to support the development of motixafortide in pancreatic cancer, noting that the company retained rights to the indication under its out-licensing agreement with Ayrmid.
Columbia University, supported by Regeneron and BioLineRx, is running the randomized Phase IIb CheMo4METPANC trial. The study is evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and the chemotherapies gemcitabine and nab-paclitaxel.
Serlin said enrollment continues to track well and that a pre-specified interim futility analysis is expected later this year when 40% of progression-free survival events have occurred.
Asked by John Vandermosten of Zacks about next steps if the study is successful, Serlin said the company is evaluating how emerging data in pancreatic cancer, including from Revolution Medicines, may affect the treatment landscape. He said BioLineRx will look at whether the data support CXCR4 inhibition as a “backbone agnostic adjunctive strategy across platforms” before deciding how best to proceed.
APHEXDA Sales Increase Year Over Year
BioLineRx also discussed APHEXDA, which Ayrmid is commercializing for stem cell mobilization in multiple myeloma. Serlin said APHEXDA generated $2.5 million in sales in the first quarter of 2026, up from $1.4 million in the first quarter of 2025. BioLineRx recorded $0.5 million in royalty revenue from those sales.
Serlin said the company remains optimistic about APHEXDA’s role in the multiple myeloma treatment paradigm and looks forward to continued growth. Under the Ayrmid agreement, Ayrmid also has rights to develop motixafortide across other indications, excluding solid tumors, and in all territories outside Asia.
Serlin said Ayrmid is continuing to develop motixafortide in sickle cell disease, where he said there is a need for better mobilization agents because G-CSF is contraindicated in patients with the disease.
First-Quarter Financial Results
Chief Financial Officer Mali Zeevi said revenue for the three months ended March 31, 2026, was $0.5 million, compared with $0.3 million in the same period of 2025. The increase reflected higher royalties from Ayrmid’s commercialization of APHEXDA.
Research and development expenses were $2.5 million, compared with $1.6 million a year earlier, primarily due to expenses related to the GLIX1 project. General and administrative expenses were $0.9 million, compared with $1 million in the prior-year period, with the decline attributed mainly to lower legal expenses and other administrative costs.
Net non-operating income was $0.5 million, compared with $7.6 million in the first quarter of 2025. Zeevi said the non-operating income primarily related to non-cash fair value adjustments of warrant liabilities tied to changes in the company’s share price, offset by warrant offering expenses.
BioLineRx reported a net loss of $2.6 million for the quarter, compared with net income of $5.1 million in the first quarter of 2025. The company ended the quarter with $17.4 million in cash and equivalents, which Zeevi said is sufficient to fund its current operating plan into the first half of 2027.
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.
